PROMIS Pain Interference Research Articles

Defining Substantial Clinical Benefits of PROMIS Pain Interference and Physical Function in Patients Undergoing Lumbar and Thoracolumbar Spine Surgery.

Prospective cohort study. This study aims to define Substantial Clinical Benefit (SCB) thresholds for PROMIS physical function (PF) and pain interference (PI) in lumbar or thoracolumbar spine surgery population. Patient-reported outcome measures (PROMs) are widely used in spine surgery to assess treatment efficacy. SCB is a relatively new concept that represents a substantial improvement perceived by the patient. This is a prospective study that included adults aged 21-85 years, undergoing lumbar/ thoracolumbar surgery for degenerative spine disease, and reporting at least 3/10 back or leg pain on a numeric rating scale. PROMs including Oswestry Disability Index, PROMIS PF, and PROMIS PI were collected preoperatively and at one year postoperatively. The North American Spine Surgery Patient Satisfaction (NASS) Index was collected one year postoperatively. SCB thresholds of absolute and percentage changes were calculated using anchor-based methods with ODI and NASS index as anchors. ROC analysis was used to determine optimal SCB cutoffs. We included 137 patients. Using a fixed 19-point reduction in ODI as an anchor yielded SCB thresholds of 6.8 and 11.3 points for PROMIS PF and PI respectively. When using a dynamic anchor based on preoperative disability (50% ODI improvement), SCB thresholds were defined as achieving 18 and 27% of maximum possible improvement for PROMIS PF and PI respectively. Using NASS index, thresholds were 11 points or 24% for PROMIS PF, and 11.2 points or 21% for PROMIS PI. ROC values ranged from 0.81 to 0.9, with the dynamic ODI anchor cutoffs demonstrating the best discrimination. Our study is the first to define SCB thresholds for PROMIS PF and PROMIS PI using both fixed and dynamic cutoffs based on preoperative disability in lumbar and thoracolumbar patients. These thresholds will help in patient counseling and outcome evaluation for spine surgery research.

Outcomes of Concentrated Bone Marrow Aspirate with Extracellular Matrix in Pediatric and Adolescent Patients with Capitellar Osteochondritis Dissecans.

Humeral capitellar osteochondritis dissecans (OCD) lesions can be challenging to treat. Past studies have demonstrated grafting with extracellular matrix with bone marrow aspirate concentrate (ECM-BMAC) to be a viable technique for treatment of talar dome OCD, though little literature exists regarding application of this technique to the capitellum. This study aimed to report patient-reported outcomes (PROs) and return to sport (RTS) of pediatric patients at ≥1-year postoperatively who underwent ECM-BMAC grafting for capitellar OCD lesions. A consecutive, single surgeon series of patients aged <18 years with unstable, contained humeral capitellum OCD who underwent ECM-BMAC grafting and had ≥1-year of clinical follow-up were included. Elbow range of motion (ROM), RTS time, postoperative sport level, and complications were recorded at follow-up visits. PROs, including Hospital for Special Surgery (HSS) Pedi-FABS, QuickDASH, Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility, PROMIS Pain Interference, and PROMIS Upper Extremity, were obtained at baseline and ≥1-year postoperatively. Both PROs and ROM were compared pre- and postoperatively using Wilcoxon Signed-Rank tests based on normality testing with Shapiro-Wilk tests. Twenty patients were included (mean age 12.8 ± 1.4 years) with an average 22.2 ± 13.0 months follow-up. Fifteen (75%) patients were female. The most common primary sports were gymnastics, baseball/softball, and racquet sports. Flexion improved significantly at ≥1-year postoperative, while extension remained close to full pre- and postoperatively. PROs improved from pre- to postoperative for all assessed instruments except for the HSS Pedi-FABS. Eighteen patients returned to their primary sport at the same competitive level or higher at a mean 5.8 ± 1.2 months. The two patients who did not return to their primary sport changed sports due to preferences unrelated to their elbow. There were no complications (e.g. infection, stiffness, revision surgery). This study demonstrated that ECM-BMAC grafting is a viable treatment strategy for pediatric patients with unstable, contained capitellar OCD lesions. We observed favorable PROs with a ∼90% RTS rate ≥1-year postoperatively, supporting the results of this technique that has demonstrated success in other anatomic regions and adult populations. These findings suggest ECM-BMAC grafting to be a viable treatment option for contained capitellar OCD lesions. Although these early results are promising, longer-term research studies are paramount in determining the outcomes of patients with capitellum OCD lesions treated with ECM-BMAC grafting.

Responsiveness and clinical utility of PROMIS instruments in pediatric Crohn's disease: insights from a longitudinal study.

Inflammatory bowel disease (IBD) may adversely affect physical, psychological, and social well-being. Integrating patient-reported outcomes (PROs) into clinical practice is crucial for comprehensive disease management. To evaluate the responsiveness and clinical utility of Patient-Reported Outcomes Measurement Information System (PROMIS) instruments, compared with standard clinical assessment tools in pediatric CD patients. A longitudinal, prospective study with 31 pediatric Crohn's disease (CD) patients aged 8-17 years recruited from a Pediatric Gastroenterology Unit. Data were collected at baseline and every 6 months over 18 months. PROMIS pediatric measures assessed PROs. Disease activity was evaluated using the pediatric Crohn's disease activity index (PCDAI) and clinical markers. IMPACT-III was also applied. Linear mixed-effects models (LMMs) and bivariate analyses were used to assess changes over time. PROMIS Global Health scores showed significant improvement over time, indicating enhanced overall health perceptions among patients. Notable reductions were observed in PROMIS Pain Interference and Fatigue scores, indicating better physical health. PROMIS depression scores generally decreased, suggesting improved mental health. PCDAI scores, hemoglobin, and platelet count significantly changed and correlated with PROMIS measures. Globally, the study demonstrated significant and clinically relevant changes in multiple PROMIS measures, confirming their responsiveness to changes in disease activity. PROMIS instruments are clinically useful in managing pediatric CD, providing valuable insights into global health and quality of life. Integrating PROMIS measures into routine clinical practice may enhance disease management and treatment strategies for pediatric IBD patients.

Long-term Postural Stability Changes After Correction of Spinal Deformity: A prospective, controlled pilot study.

Prospective cohort study. This study aimed to investigate the durability of postural stability after ASD correction surgery and its' association with clinical outcomes. The prevalence of symptomatic adult spinal deformity (ASD) necessitates surgical intervention, aiming to correct global spinal balance and spinopelvic parameters. Short-term studies have shown improvements in postural control following surgery, but the long-term impact remains unclear. This single-center prospective cohort study included adult patients undergoing long-segment fusion surgery between November 2019 and July 2021. Preoperative and postoperative balance assessments, radiographic analyses, and patient-reported outcome measures (PROMs) were conducted. Statistical analyses evaluated changes in postural stability and clinical outcomes. Fifteen ASD patients were analyzed. Significant improvements were observed in the early postoperative period in coronal center of pressure (COP) sway (P=0.048) and amplitude (P=0.027), total COP sway (P=0.042), coronal center of gravity (COG) amplitude (P=0.013), total COG sway (P=0.044), and head sway in the coronal plane (P=0.025). These improvements were maintained at the final postoperative visit for all measurements except coronal COG amplitude (early vs. last postoperative visit, P=0.040). Radiographic parameters, including pelvic incidence - lumbar lordosis mismatch (P=0.041) and sagittal vertical axis (P=0.032), also significantly improved postoperatively. PROMs revealed significant enhancements in VAS back pain (P=0.045), RAND SF-36 pain (P=0.016), RAND SF-36 physical functioning (P=0.008), and PROMIS pain interference (P=0.032) scores at the last follow-up. These results demonstrate that the postural stability improvements seen after ASD correction are durable and correlate with enhanced clinical outcomes, such as reduced back pain and improved physical functioning. These findings underscore the clinical importance of achieving sagittal alignment in ASD patients. Further research with larger cohorts and extended follow-up periods is warranted to confirm these associations and establish postural stability assessment as a vital parameter in evaluating patients' quality of life postoperatively. Level 3.

Back pain disability and PROMIS scores in children with hyperkyphosis are worse than children with idiopathic scoliosis.

To compare health-related quality-of-life (HRQOL) between children with hyperkyphosis and idiopathic scoliosis using 9-item Oswestry Disability Index (ODI-9) and Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference, Mobility, and Anxiety. Children with hyperkyphosis, idiopathic scoliosis, and controls with no structural diagnosis ages 10-18years who completed the PROMIS Pediatric Pain Interference, Mobility, and Anxiety domains were retrospectively evaluated from April 2021 to June 2023. Comparisons were made between hyperkyphosis, idiopathic scoliosis, and control groups. Within the hyperkyphosis group, comparisons were made between Scheuermann kyphosis and postural kyphosis subgroups. 304 children with hyperkyphosis, 1134 with idiopathic scoliosis, and 1493 controls were included. Children with hyperkyphosis had increased age, male sex, BMI percentile, Spanish than English speakers, and public insurance type. They also had worse ODI-9, PROMIS Pain Interference and Mobility scores which remained significant after multivariate regression analysis included age, sex, BMI percentile, language, insurance type, and race/ethnicity (p < 0.01). The Scheuermann kyphosis (n = 67) subgroup had increased age, male sex, area deprivation index (ADI), BMI percentile, concern by their appearance, and worse PROMIS Pain Interference and Mobility scores than the postural kyphosis (n = 237) subgroup. However, Scheuermann kyphosis subgroup score differences did not remain significant after considering age, sex, ADI, and BMI percentile. Children with hyperkyphosis (both Scheuermann and postural kyphosis subtypes) have worse HRQOL scores than their peers with idiopathic scoliosis. Worse ODI-9, PROMIS Pain Interference and Mobility scores remained significant only in the hyperkyphosis group as a whole after adjusting for confounding variables, but not between hyperkyphosis subgroups.

Lower socioeconomic status is correlated with worse outcomes after arthroscopic rotator cuff repair

BackgroundSocioeconomic status has been recognized as a crucial social determinant of health influencing patient outcomes. Area Deprivation Index (ADI) is a validated measure of an area’s socioeconomic status. Limited data exists on the impact of ADI and clinical outcomes and complications following rotator cuff repair (RCR). The purpose of this study was to investigate the impact socioeconomic factors have on outcomes following primary arthroscopic RCR.MethodsThis is a retrospective cohort study with 1-year follow-up. Patients who underwent primary rotator cuff repair at a single institution from March 2014 to September 2022 were identified. Patient demographics, pre-and post-operative visual analog scale (VAS) scores, Patient-Reported Outcomes Measurement Information System (PROMIS) scores, range of motion, complications, and subsequent ipsilateral shoulder surgeries were collected. ADI was collected from an online mapping database using each patient’s home address. Patients were split into ADI terciles, with ADI1 representing the least disadvantaged group and ADI3 representing the most disadvantaged group. Analysis of variance and T-test were used for continuous variables, and chi-square analyses were conducted for categorical variables.ResultsIn total, 467 patients underwent RCR and had complete demographic data and postoperative follow-ups over a year. There was a significant difference in race, with 78.2% of patients identifying as black in ADI3 and 18.1% in ADI1 (P < .001). Pre-operative PROMIS-Pain Interference, VAS, forward flexion, and abduction were significantly worse in ADI3 compared to ADI1 (P = .001, P < .001, P = .012, and P = .023). At one-year postoperative, patients in ADI3 scored significantly worse than patients in ADI1 in PROMIS- Upper Extremity score (P = .016), PROMIS- Pain Interference (P < .001), VAS (P < .001), forward flexion (P < .001) and abduction (P = .034). Higher ADI scores were associated with a positive correlation for pain (r = .258, P = < 0.001) a negative correlation with upper extremity function (r = − .233, P = .026), a positive correlation with pain interference (r = .355, P < .001), and negative correlation with forward flexion (r = − .227, P < .001). There were no significant differences in postoperative complications (P = .54), retears (P = .47), or reoperations rates (P = .22).ConclusionLower socioeconomic status measured by ADI is associated with worse preoperative and 1-year postoperative pain, shoulder function, and range of motion following RCR. However, no differences were appreciated between cohorts regarding reoperation or complications.Level of Evidence IIIRetrospective Cohort Study.

The Psychological Impact of Adult Traumatic Brachial Plexus Injury.

Adult traumatic brachial plexus injuries (BPIs) present a significant medical challenge, potentially leading to life-altering consequences for patients' upper extremity pain and function. However, the psychological impact on patients has not been extensively studied. Adult patients with traumatic BPIs treated at 2 tertiary referral centers in the United States from 2015 to 2019 were retrospectively identified. This cohort of 84 patients was targeted for prospective interviews, and 44 patients (52%) responded. Validated measures including the posttrumatic stress disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders: Fifth Edition (PCL-5), Decision Regret Scale, Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity, PROMIS Pain Interference, PROMIS Upper Extremity, and Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) were obtained through telephone-based interviews. Additional data were collected through electronic medical record review. On average, patients experience low post-traumatic stress (median score 6, interquartile range [IQR] 3-20) and decision regret (median score 5, IQR 0-22.5). However, a notable fraction (18%) of patients met the clinical threshold for PTSD. Significant correlations were observed between PCL-5 scores and worse PROMIS Pain Intensity, PROMIS Pain Interference, PROMIS Upper Extremity, and QuickDASH. Decision regret scores correlated with worse PROMIS Upper Extremity and QuickDASH. While the overall incidence of PTSD and treatment decision regret after adult traumatic BPI is low, clinical PTSD was found in a significant percentage of patients associated with pain and functional impairment. This study highlights the importance of understanding and addressing the psychological burden of traumatic BPI.

Opioid-Induced Constipation and Associated Symptoms After Orthopedic Trauma

PurposeOpioid-induced constipation is an adverse effect often experienced among patients taking prescription opioid medication. Despite frequent opioid prescribing after orthopedic injury, there is a dearth of research examining opioid-induced constipation presentations in this population. This analysis examines the frequency of opioid-induced constipation manifestations and association with patient-reported outcomes among participants prescribed opioid medication following orthopedic injury. DesignSecondary analysis of 86 clinical trial participants following orthopedic trauma. MethodsParticipants were assessed 2-weeks postoperatively with the following measures: Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference, PROMIS Physical Function, past 24-hour average pain intensity captured on the numeric pain rating scale, and the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. Linear regressions examined the association between PAC-SYM scores and both pain intensity and PROMIS T-scores while accounting for injury severity and opioid medication dosage. ResultsMost participants (69%) reported experiencing opioid-induced constipation symptoms and 7% reported moderate to severe symptoms. Compared to those without symptoms, participants reporting opioid-induced constipation symptoms were found to have a 3-point increase in PROMIS Pain Interference (95% Confidence Interval [CI]: 0.28-5.90; p = .032), a 3-point decline in PROMIS Physical Function (95% CI: -6.57 to -0.02; p = .049), and a 1.7-point increase in average pain scores (95% CI: 0.50-3.01; p = .007) at 2-weeks following surgery. ConclusionsOpioid-induced constipation symptoms are common after orthopedic trauma and linked to increased pain interference and pain intensity as well as reduced physical function. Clinical ImplicationsNurse-led assessments of opioid-induced constipation can support the timely delivery of interventions to alleviate symptoms and potentially improve patient-reported outcomes after injury.

Patient-Reported Outcomes Associated With "Completely Better" Status at 2 Years After Hip Arthroscopy.

Measures such as the Patient Acceptable Symptom State and minimum clinically important difference have been used to contextualize patient-reported outcomes (PROs). Assessment of patients' perception of being "completely better" (CB) after hip arthroscopy has not been studied. To (1) determine the prevalence and characteristics of patients who report being CB at 2 years after hip arthroscopy; (2) determine whether PROs measuring function, pain, and mental health are associated with CB status; and (3) determine threshold values for PROs predictive of achieving CB status. Case-control study; Level of evidence, 3. Patients undergoing hip arthroscopy at a single institution from October 2015 to January 2020 were administered electronic surveys assessing sociodemographic variables and PROs at baseline and 2 years postoperatively. The CB anchor question was "Is the condition for which you underwent surgery completely better now?" Threshold values for PROs associated with achieving CB status at 2 years postoperatively were identified with 90% specificity. Variables with an area under the curve of >0.80 on a receiver operating characteristic curve were selected for multivariate analysis. Overall, 29 of 62 patients (47%) achieved CB status. There were no differences in age, sex, body mass index, race, prior hip surgery, preoperative opioid use, smoking status, or preoperative expectations between the CB and no-CB groups. The CB group had better 2-year postoperative and pre- to postoperative change values on all PROs (P < .05 for all) except for the Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression and the Numeric Pain Scale (NPS) for whole-body pain. Two-year postoperative PRO thresholds for achieving CB status were determined as PROMIS-Physical Function (PF) ≥51.3 or increase in PROMIS-PF ≥12 points, PROMIS-Pain Interference ≤46.6 or decrease in PROMIS-Pain Interference ≥12.2 points, NPS for operative hip pain of ≤1.0, Musculoskeletal Outcomes Data Evaluation and Management System-expectations met ≥95.0, and Surgical Satisfaction Questionnaire (SSQ-8) ≥87.5. Multivariate analysis demonstrated that higher SSQ-8 score and greater improvement on the PROMIS-PF were independent predictors of achieving CB status. Almost half of the study patients perceived being CB at 2 years after hip arthroscopy. Multiple postoperative PROs scores were associated with achieving CB status.

Patient-Reported Outcomes after Surgery for Pigmented Villonodular Synovitis in the Knee: A Cohort Study.

Pigmented villonodular synovitis (PVNS) is a rare neoplastic proliferation of large joints, including the knee, with both localized PVNS (LPVNS) and diffuse PVNS (DPVNS) types. DPVNS is known to recur at a higher rate following resection; however, there is little evidence comparing patient-reported outcomes (PROs) between the two types. The purpose of this study was to compare PROs between patients with LPVNS and DPVNS involving the knee 2 years after surgical resection. We hypothesized that DPVNS would have worse 2-year PROs than LPVNS.Sixteen patients who underwent arthroscopic resection of pathology-confirmed PVNS involving the knee were enrolled in a prospective registry. Several PROs, including six Patient-Reported Outcomes Measurement Information System (PROMIS) domains and the International Knee Documentation Committee (IKDC) Subjective Knee Form, were assessed at baseline and at 2 years postoperatively. Mean scores between LPVNS and DPVNS groups were compared using a Wilcoxon exact test, while categorical variables were compared using a Fisher's exact test.Eleven patients (seven LPVNS and four DPVNS) completed both the baseline and 2-year PRO surveys. There were no significant differences in the demographic variables between groups, including age, body mass index, or prior surgical history (p < 0.05). There was a trend toward higher mean PRO scores in the DPVNS group at 2 years postoperatively in all measures, despite lower reported baseline levels of activity as measured by Marx Activity Rating Scale (26.3 vs. 76.7, p = 0.02). The DPVNS group also trended toward more improvement in PROMIS Physical Function (9.7 vs. -2.7), PROMIS Pain Interference (-9.0 vs. -2.5), PROMIS Anxiety (-5.4 vs. -4.4), and IKDC (26.7 vs. 18.9). However, these differences did not reach statistical significance (p < 0.05). There were two recurrences in the DPVNS group and none in the LPVNS group.Patients with knee DPVNS do not report worse outcomes 2 years after arthroscopic resection compared with LPVNS patients.

Oral ketamine for acute postoperative analgesia (OKAPA) trial: A randomized controlled, single center pilot study

Study objectiveAlthough opioids represent the mainstay of treating surgical pain, their use is associated with significant side effects. There is an urgent need to find new pain relievers with safer side effect profiles. One drug that has been receiving increasing attention is ketamine. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. This study aims to examine the role of oral ketamine in improving recovery after major spine surgery. DesignA prospective, single-center, double blinded parallel arm, placebo controlled randomized feasibility trial. SettingToronto Western Hospital (TWH), UHN, Toronto, Canada. PatientsAdult patients (aged 18–75) undergoing multi-level lumbar spine decompression and fusion with planned overnight admission in hospital. InterventionsStudy treatment (oral ketamine 30 mg) or matching placebo for three days (nine doses total) or until hospital discharge. MeasurementsThe primary outcome was the patient-reported Quality of Recovery-15 score (QoR-15). Secondary outcomes were opioid use, pain intensity, pain interference (PROMIS-pain interference questionnaire), mood (PHQ-9) and, side-effects (Generic Assessment of Side Effects Scale). Main resultsData from 35 patients were analyzed, of which 18 patients in the ketamine group and 17 patients in the placebo group. There were no significant differences identified in QoR-15 scores at postoperative days 1,3,7, and 30. There were also no significant differences found in pain intensity scale scores at postoperative days 1, 3, 7, and 30, and PROMIS and PHQ-9 scores at postoperative days 7 and 30. Significantly less oral opioids were used in the ketamine group compared to the placebo group on postoperative day 3 and by postoperative day 7. In addition, patients in the ketamine group spent significantly less days on oral opioids and trended to be discharged from hospital earlier. ConclusionThis pilot study demonstrated that low dose oral ketamine can be safely used as an adjunct in postoperative pain treatment to help reduce opioid consumption after major spine surgery.

Defining Clinically Significant Outcome Thresholds for the Patient-Reported Outcomes Measurement Information System (PROMIS) at 2 Years After Gluteus Medius and/or Minimus Repair.

Clinically significant outcome (CSO) thresholds are invaluable to the interpretation of patient-reported outcomes (PROs). The Patient-Reported Outcomes Measurement Information System (PROMIS) is gaining popularity among the orthopaedic community; however, CSO thresholds for PROMIS are yet to be defined for outcomes after gluteus medius and/or minimus (GM) repair. To (1) define CSO thresholds for PROMIS-Pain Interference (PROMIS-PI) and PROMIS-Physical Function (PROMIS-PF) after GM repair, (2) correlate these PROMIS scores with legacy hip-specific PROs, and (3) quantify their floor and ceiling effects. Case series; Level of evidence, 4. Consecutive patients who underwent primary GM repair between September 2017 and June 2021 with completed PROMIS at minimum 2-year follow-up were evaluated. The minimal clinically important difference, Patient Acceptable Symptom State, and substantial clinical benefit thresholds were defined for the PROMIS-PI and PROMIS-PF as well as for legacy PROs: Hip Outcome Score-Activities of Daily Living (HOS-ADL) and Hip Outcome Score-Sports Subscale (HOS-SS); modified Harris Hip Score (mHHS); 12-item International Hip Outcome Tool (iHOT-12); and the visual analog scale (VAS) for pain and satisfaction. Pearson correlations were performed between PROMIS scores and legacy PROs. Rates of floor and ceiling effects were quantified. Overall, 107 patients (81.7% follow-up compliance; mean age, 59.8 ± 8.8 years; 92.5% female; mean body mass index, 28.6 ± 6.3 kg/m2) were included in the analysis. GM tears were partial thickness in 56.1% of cases and treated endoscopically in 64.5% of cases. The minimal clinically important difference, Patient Acceptable Symptom State, and substantial clinical benefit thresholds, respectively, were as follows: PROMIS-PI (-4.6, 56.0, 52.6), PROMIS-PF (3.5, 42.7, 43.7), HOS-ADL (10.7, 68.2, 78.6), HOS-SS (16.5, 58.6, 60.6), mHHS (9.0, 64.3, 71.5), iHOT-12 (14.2, 63.6, 69.4), VAS pain (-16.1, 34.9, 28.1), and VAS satisfaction (not applicable, 70.9, 93.6). Moderate to strong correlations were observed between the PROMIS and legacy PROs. The PROMIS-PI showed a significant postoperative floor effect of 18.7%. Study findings indicated that the PROMIS is effective for use in GM repair patients, given the moderate-to-strong correlations between the PROMIS and legacy hip-specific PROs, the mostly limited floor and ceiling effects, and large effect sizes. Use of PROMIS instead of legacy PROs may aid in limiting survey burden.

Does the Use of a Tourniquet Influence Five-Year Outcomes Following Total Knee Arthroplasty?

BackgroundA tourniquet is commonly used during total knee arthroplasty (TKA) to improve surgical field visibility and minimize blood loss. While the short-term effects of tourniquet use on postoperative outcomes have been studied extensively and found to be minimal, its influence on longer-term outcomes remains underexplored. This study examined tourniquet use in TKA with up to five-year follow-up. MethodsIn this post hoc analysis of a randomized controlled trial, 227 patients who underwent primary TKA in the tourniquet (T) group (n = 112) or no tourniquet (NT) group (n = 115) were evaluated. Clinical outcomes and patient-reported outcome measures (PROMs) were compared between the two groups. ResultsThe T group had non-significant trends toward reduced blood loss (131.8 versus 116.7 ml, P = 0.098) and shorter operative time (97.8 versus 95.7 minutes, P = 0.264), with slightly higher postoperative day-one Visual Analog Scale (VAS) pain scores (3.1 versus 3.6, P = 0.197). Length of stay (2.0 versus 2.1 days, P = 0.837) and home discharge rate (88.7 versus 92.0%, P = 0.340) were comparable. The NT group had three 90-day readmissions, while none occurred in the T group (2.7 versus 0%, P = 0.081). The active range of motion at the final follow-up was similar between groups (108.3 versus 106.5 degrees, P = 0.457). All-cause revision rates at five years were comparable between the NT and T groups (5.2 versus 3.6%, P = 0.546). Kaplan-Meier survivorship analysis revealed comparable aseptic implant survival at five years (P = 0.769). There were no significant differences in Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR), Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity, PROMIS pain interference, or PROMIS physical health scores at three months, one year, and five years postoperatively. ConclusionUsing a tourniquet during primary TKA was not associated with differences in clinical or patient-reported outcomes at up to five-year follow-up. These findings suggest that tourniquet use in TKA can be left to the surgeon’s discretion.

Influence of Social Deprivation on Patient-Reported Outcomes in Foot and Ankle Patients.

The impact of social health on patient-reported outcomes (PROs) is gaining increasing attention within the orthopaedic community. Few studies have explored any relationship between social deprivation levels and PROs in orthopaedic foot and ankle patients. We retrospectively identified patients who presented to an orthopaedic foot and ankle clinic for new evaluation. Patients completed PROs including PROMIS physical function (PF), PROMIS pain interference (PI), and the Foot and Ankle Ability Measure (FAAM). Social deprivation was measured using the Area Deprivation Index (ADI), a metric that incorporates various domains of poverty, education, housing, and employment. The ADI score quantifies the degree of social deprivation based on the 9-digit home zip code but is not a specific measure to an individual patient. Briefly, a lower ADI indicates less deprivation whereas a higher score denotes greater deprivation. Patient characteristics and outcomes were summarized and stratified by the nationally defined median ADI. Multivariable linear regression models assessed the relationships between PROs and continuous ADI controlling for demographics (age, sex, race/ethnicity, marital status, and employment status). Our cohort consisted of 1565 patients with PRO and appropriate zip code data. Patients in the most-deprived median ADI split had more pain (median PROMIS-PI 62.7 vs 61.2, P = .001) and less function (median PROMIS-PF 37.1 vs 38.6, P = .021) compared with the least-deprived median ADI split. The clinical significance of these findings is unclear, though, given the minimal differences between groups for PROMIS measures. There was no relationship between ADI and FAAM scores. More socially deprived patients presented to the clinic with marginally less function and greater pain. Although statistically significant, the clinical significance of these relationships is unclear and merits further exploration. We plan to continue to study the connection between social deprivation and patient outcomes in specific clinical conditions as well as before/after surgical interventions. Level IV, retrospective cases series.

Cobalt-Chrome 3D-Printed Total Talus Replacement with and without Combined Total Ankle Replacement Improve Functional Scores and Radiographic Outcomes

Category: Hindfoot; Ankle Introduction/Purpose: Collapse of the talus and peri-talar arthritis pose treatment challenges due to the anatomy and location of the talus as a keystone of the foot and ankle. Custom 3D-printed total talus replacement (TTR) and combined total ankle total talus replacement (TATTR) have emerged as treatment options for peri-talar arthritis, avascular necrosis of the talus and talus insufficiency. However, long-term data on the safety and efficacy of these implants is unknown due to the limited number of cases and short follow-up durations. Methods: This was a retrospective study to assess surgical outcomes of patients who underwent a TTR and TATTR with or without subtalar fusion. Patient demographics, intraoperative parameters, device related surgical and non-surgical events, imaging and clinical evaluations, and patient reported outcome (PRO) measures were compiled for each case. The Odds Ratio (OR) for secondary surgery was calculated for each binary outcome using univariate and multivariate logistic regression. The multivariable model included significant variables from the univariate analysis to address potential confounders. Pre- and postoperative radiographic measurements and range of motion were compared using pairwise t-tests. Pain VAS, PROMIS Pain Interference (PI), and PROMIS Physical Function (PF) scores were compared across all timepoints using one-way ANOVA (p&lt; 0.05 significance level). Results: A total of 38 patients received a custom 3D-printed implant with mean follow-up time of 22.1 (range: 12-45) months. In this cohort, 7 (18.4%) required secondary surgery and 3 (7.9%) required removal of the implant. The mean time to secondary surgery was 19.9 (range: 11-32) months. Multivariate logistic regression revealed that patient diagnosis of depression was a significant predictor of secondary surgery with an OR 17.50 (p= 0.037). Significant postoperative improvements were observed in talocalcaneal height (p=0.005) and talar declination angle (p=0.013) for the TATTR group. VAS and PROMIS PI scores demonstrated an initial significant decrease in pain, but this improvement did not maintain significance at most recent follow-up. However, there was a significant increase in the PROMIS PF scores (p=0.037) at most recent follow-up. Conclusion: These results demonstrate that TTR and TATTR provide improvement in radiographic foot and ankle alignment and physical function. PRO findings suggest that patients are more active despite steady pain increase over time. Surgeons considering proceeding with either of these procedures should counsel patients about pain and functional outcomes as well as realistic expectations in patients with depression. Larger cohorts of patients should be studied to identify other high-risk groups and possible interventions. Future studies should investigate the association between diagnoses like depression and PROs.

Prevalence and Factors Associated With High-Impact Chronic Pain in Knee Osteoarthritis: The Johnston County Health Study

Pain is a hallmark symptom of knee osteoarthritis (KOA), yet intensity and severity vary widely among individuals. There is a knowledge gap in understanding key characteristics of high-impact chronic pain (HICP) within the context of KOA. Therefore, our first purpose was to examine the prevalence of HICP in a cohort of individuals with radiographic evidence of KOA, and our second purpose was to assess patient-level factors associated with HICP. Data from the Johnston County Health Study were used to compare those with and without HICP. Variables included sociodemographic factors, clinical factors, health care use, and psychosocial distress. HICP status was classified with Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Physical Function measures. The results indicated that 15.5% (48/310) of participants were classified as having HICP when the PROMIS-Pain Interference cutoff score was used, while 21.2% (66/310) were classified as having HICP with a PROMIS-Physical Function cutoff score. Multivariable analyses indicated that HICP was consistently characterized by increased kinesiophobia and somatization, regardless of PROMIS measure used for HICP status. A secondary insight was that HICP was not consistently characterized by sociodemographic and clinical variables, as these findings were dependent on PROMIS measure used. These findings could be used to develop intervention approaches specific to individuals with KOA and to inform future investigations of sociodemographic and clinical factors associated with HICP. PerspectiveThese findings provide additional information on the characterization of HICP for individuals with KOA. There was consistency in psychosocial factors associated with HICP, while sociodemographic and clinical factors varied based on how HICP status was defined.

Sleeve gastrectomy prior to primary total hip and total knee arthroplasty is associated with increased risk of early complications

AimsThe purpose of this study was to determine the association between prior sleeve gastrectomy in patients undergoing primary total hip and knee arthroplasty, and 90-day complications, incidence of revision arthroplasty, and patient-reported outcome scores at final follow-up.MethodsThis is a retrospective, single-centre analysis. Patients undergoing primary hip or knee arthroplasty with a prior sleeve gastrectomy were eligible for inclusion (n = 80 patients). A morbidly obese control group was established from the same institutional registry using a 1:2 match, for cases:controls with arthroplasty based on propensity score using age, sex, pre-sleeve gastrectomy BMI, Current Procedural Terminology code to identify anatomical location, and presurgical haemoglobin A1C. Outcomes included 90-day complications, incidence of revision arthroplasty, and patient-reported outcome scores at final follow-up. Multivariable logistic regressions evaluated associations of underlying preoperative demographic and treatment characteristics with outcomes.ResultsComplications within 90 days of surgery were increased in the sleeve gastrectomy group relative to the obese control group after controlling for underlying preoperative demographic characteristics (odds ratio (OR) 4.00 (95% CI 1.14 to 13.9); p = 0.030). Postoperative revisions were similar in the sleeve gastrectomy group relative to the obese control group after controlling for underlying preoperative demographic characteristics (OR 17.8 (95% CI 0.64 to 494.3); p = 0.090). Patient-Reported Outcomes Measurement Information System (PROMIS) depression decreased by a greater amount from pre- to postoperative in the obese controls relative to the sleeve gastrectomy group (OR 4.04 (95% CI 0.06 to 8.02); p = 0.047). PROMIS pain interference and physical function change from pre- to postoperative was not associated with sleeve gastrectomy status.ConclusionWe found a higher rate of complications at 90 days in patients who underwent sleeve gastrectomy prior to primary hip or knee arthroplasty relative to a matched, obese control population. Prosthetic revision rates were similar between the two groups, while improvements in PROMIS depression scores were larger in the obese cohort. This study suggests that sleeve gastrectomy to achieve preoperative weight loss prior to arthroplasty surgery may not mitigate early complication risks in obese patient populations.Cite this article: Bone Joint J 2024;106-B(9):935–941.

Feasibility of Obtaining Patient-Reported Outcome Measures in a High-Volume Multidisciplinary Surgical Limb Salvage Center.

Completion of patient-reported outcome measures (PROMs) is labor-intensive but paramount in improving patient-centered care, allowing for advancement of techniques and scrutinization of outcomes. We report the feasibility of PROM collection and reporting for patients seen in a high-volume, multidisciplinary, tertiary limb salvage center to determine pain and functionality outcomes. The center received grant funding resources for large-scale PROM collection. Patients completed either tablet or paper surveys. Functionality and pain PROMs included 1) Neuro-QoL Lower Extremity Function-Mobility, 2) Numerical Rating Scale, 3) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity, and 4) PROMIS Pain Interference. Research assistants attended clinic daily to administer surveys. Patients were categorized into the following groups: amputation, flap reconstruction, other surgical management, and nonsurgical management. Five hundred sets of each survey were administered to 420 patients across 2 months, with 16% of patients (n = 80) completing multiple sets at separate visits. The completion rate among eligible patients was 90% or greater for each PROM. Of the respondents, 133 (31.7%) were seen for previous amputation, 32 (7.6%) for local or free flap reconstruction, 68 (16.2%) for other surgical management (eg, debridement, arthroplasty), and 295 (70.2%) for nonsurgical management (eg, lymphedema, hidradenitis). We report that integration of PROM collection in a high-volume limb salvage center is feasible. These metrics allow measurement of the impact and effectiveness of salvage or amputation surgeries from patients' perspectives, providing quantification of satisfaction and aspects of health-related quality of life, improved patient advocacy, and an evidence-based approach to surgical management.

The Impact of Blood Flow Restriction Training on Tibial Bone Stress Injury Rehabilitation: An Exploratory Case Series.

Lower extremity bone stress injuries (BSI) are common injuries among athletes and military members. Typical management involves a period of restricted weightbearing which can have rapid detrimental effects upon both muscle and bone physiology. Few studies have investigated the effect of blood flow restriction (BFR) training on bone in the rehabilitative setting. The purpose of this study was to investigate the effects of lower extremity exercise with the addition of BFR upon bone mineral density, bone mineral content, and lean body mass in military members with tibial BSIs. Case series. Twenty military members with MRI-confirmed tibial BSI were recruited to complete lower extremity exercise with the addition of BFR twice per week for four weeks. The BFR cuff was applied proximally to the participant's involved limb while they performed gluteal, thigh, and leg resistance exercises. Outcomes were assessed at baseline and four weeks. The primary outcomes were whole leg bone mineral density (BMD), bone mineral content (BMC), and lean body mass (LM) as measured by dual-energy x-ray absorptiometry. Secondary outcomes included thigh and leg circumference measures and patient-reported outcomes, including the Lower Extremity Functional Scale (LEFS), Patient-Reported Outcomes Measurement Information System 57 (PROMIS-57), and Global Rating of Change (GROC). No significant differences were found in BMD (p=0.720) or BMC (p=0.749) between limbs or within limbs over time. LM was generally less in the involved limb (p=0.019), however there were no significant differences between or within limbs over time (p=0.404). For thigh circumference, significant main effects were found for time (p=0.012) and limb (p=0.015), however there was no significant interaction effect (p=0.510). No significant differences were found for leg circumference (p=0.738). Participants showed significant mean changes in LEFS (15.15 points), PROMIS physical function (8.98 points), PROMIS social participation (7.60 points), PROMIS anxiety (3.26 points), and PROMIS pain interference (8.39 points) at four weeks. The utilization of BFR in the early rehabilitative management of tibial BSI may help mitigate decrements in both bone and muscle tissue during periods of decreased physical loading. 4.

COMPARISON OF PROMIS SCORES AFTER TOTAL HIP AND TOTAL ANKLE ARTHROPLASTY: A PROPENSITY SCORE-MATCHED STUDY

This study evaluates patient reported outcome measurement information system (PROMIS) scores after total hip arthroplasty (THA) and total ankle arthroplasty (TAA) in matched cohorts, while simultaneously evaluating implant survivorship and 90-day hospital utilization. It is hypothesized that while both procedures would yield similar PROMIS score improvements, THA would demonstrate superior mid-term implant survivorship.Primary THA and TAA patients from 2015–2022 with minimum one-year follow-up were retrospectively reviewed. After applying exclusion criteria, 2,092 THAs and 478 TAAs were included for analysis. Demographics, pre- and post-operative patient reported outcome measures (PROMs), revision surgeries, ED visits, and re-admissions were collected. THA and TAA patients were then propensity score matched at 2:1 ratio for age, sex, race, BMI, ASA, and comorbidities, resulting in a final cohort of 844 THAs and 455 TAAs for comparison.There were similar pre-operative PROMIS Pain Interference (PI) scores between THA and TAA, with both showing improvement at six weeks. However, THA patients exhibited lower PI scores at one year (53.0 versus 54.0; p=0.009). Pre-operative PROMIS Physical Function (PF) was worse in THA patients but showed greater improvement compared to TAA patients at both six weeks (p&lt;0.001) and one year (p&lt;0.001). Pre-operative PROMIS depression scores were similar and improved similarly in both groups. Joint-specific PROMs (HOOS for THA and FAAM for TAA) improved in both cohorts. THA demonstrated superior survivorship free of all-cause revision at five years compared to TAA (95% versus 77%; p&lt;0.0001).Patients undergoing THA or TAA experienced significant improvements in their general and joint-specific PROMs post-operatively. However, patients undergoing THA demonstrated higher PROMIS PI and PF scores at one-year when compared to TAA, as well as improved survivorship. Generic PRO instruments enable comparison of medical treatments in different anatomic sites to the patients overall health.