Evaluating the efficacy of intra-articular human amniotic suspension allografts for knee osteoarthritis management: A systematic review and meta-analysis.

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BackgroundThere is conflicting clinical evidence whether platelet-rich plasma (PRP) therapies could translate to an increased meniscus healing rate and improved functional outcomes. The objective of this systematic review and meta-analysis was to compare the failure rate and patient-reported functional outcomes in meniscus repair augmented with and without PRP.MethodsWe comprehensively searched the PubMed, Web of Science, Medline, Embase, and Cochrane Library databases to identify studies that compared the clinical efficacy of meniscus repair performed with PRP versus without PRP. The primary outcome was the meniscus repair failure rate, while the secondary outcomes were knee-specific patient-reported outcomes, including the International Knee Documentation Committee (IKDC) score, Lysholm knee scale, visual analog scale, Tegner activity level score, Western Ontario and McMaster Universities Osteoarthritis Index score, Single Assessment Numeric Evaluation score, and Knee injury and Osteoarthritis Outcome Score. Furthermore, subgroup analyses were performed by stratifying the studies according to the PRP preparation technique to investigate the potential sources of heterogeneity among studies.ResultsOur meta-analysis included nine studies (two RCTs and seven non-RCTs) with 1164 participants. The failure rate in the PRP group was significantly lower than that in the non-PRP group [odds ratio: 0.64, 95% confidence interval (CI) (0.42, 0.96), P = 0.03]. Furthermore, the PRP group was associated with a statistically significant improvement in the visual analog scale for pain [Mean difference (MD): − 0.76, 95% CI (− 1.32, − 0.21), P = 0.007] and Knee injury and Osteoarthritis Outcome Score-symptom [MD: 8.02, 95% CI (2.99, 13.05), P = 0.002] compared with the non-PRP group. However, neither the IKDC score nor the Lysholm knee scale showed any differences between the two groups. In addition, the results of subgroup analyses favored PRP over platelet-rich fibrin matrix (PRFM) regarding the IKDC score.ConclusionsAlthough meniscus repairs augmented with PRP led to significantly lower failure rates and better postoperative pain control compared with those of the non-PRP group, there is insufficient RCT evidence to support PRP augmentation of meniscus repair improving functional outcomes. Moreover, PRP could be recommended in meniscus repair augmentation compared with PRFM. PRFM was shown to have no benefit in improving functional outcomes.

We conducted this updated meta-analysis to evaluate the effects of PRP in patients with knee or hip OA. PubMed, Embase, and Web of Science were searched to identify randomized controlled trials (RCTs) that compared the efficacy of PRP with other intra-articular injections. The outcomes of interest included Western Ontario and McMaster (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), Visual Analog Scale (VAS), Harris Hip Score (HHS), and International Knee Documentation Committee (IKDC). Twenty-four RCTs with 21 at knee OA and three at hip OA were included in this meta-analysis. The PRP injections significantly improved the WOMAC score, VAS score, IKDC score, and HHS score as compared with comparators. The WOMAC pain, stiffness, and physical function scores were also significantly better in the PRP group than in the control group. Most of the evaluated parameters that favored PRP were observed in knee OA but not in hip OA, at short-term (at 1, 2, 3, 6, 12months) but not long-term follow-up (at 18months), in RCTs with low risk of bias. Intra-articular PRP injection provided better effects than other injections for OA patients, especially in knee OA patients, in terms of pain reduction and function improvement at short-term follow-up. Key Points • This updated meta-analysis, based on great sample size and high-quality studies, evaluates the effects of PRP in patients with knee or hip OA. • Intra-articular PRP injection provided better effects than other injections for OA patients. • Most of the evaluated parameters that favored PRP were observed in knee OA at short term (at 1, 2, 3, 6, 12months).

This study aims to evaluate clinical and patient-reported outcome measures (PROMs) of patients 40 years and older that underwent anterior cruciate ligament reconstruction (ACLR) and determine the influence of preexisting arthritis and chondral wear on ACLR outcomes. We hypothesized that patients aged 40+ with ACLR would have excellent clinical outcomes and PROMs regardless of preexisting arthritic changes. A total of 118 patients were included. Patients aged 40 years and older who underwent ACLR in a single healthcare system between 2009 and 2016 were eligible. Outcomes assessed include Knee Injury and Osteoarthritis Outcome Scores (KOOS), Single Assessment Numeric Evaluation (SANE) scores, intraoperative Outerbridge grading, preoperative Kellgren-Lawrence (KL) grading and postoperative complication rates over a 2-year period. Average increase in KOOS and SANE scores were 21.2 19.9 and 23.5 31.3, respectively. Patients with Outerbridge grade III and IV lesions in weight-bearing compartments had lower baseline SANE and KOOS scores than those without (47.1 ± 22.0 vs. 64.5 ± 23.6 baseline SANE and 43.1 ± 18.1 vs. 63.5 ± 15.9 baseline KOOS; p = 0.002 and p < 0.001, respectively) with no significant difference in the amount of change in SANE or KOOS scores (p = 0.111 and p = 0.165 respectively). Patients with KL-grade 2+ osteoarthritis experienced similar changes in KOOS and SANE over the 2-year period to their counterparts (p = 0.598 and p = 0.643, respectively). There is no correlation between preexisting osteoarthritic changes or chondral defects and PROs. KOOS and SANE scores both increased postoperatively. When treating older patients with an ACL tear, surgeons should consider the activity level and desires of the patient as they determine appropriate treatment. Preexisting osteoarthritis does not correlate with patient-reported outcomes for ACLR. Level IV.

Background:Knee injury among young, active female patients remains a public health issue. Clinicians are called upon to pay greater attention to patient-oriented outcomes to evaluate the impact of these injuries. Little agreement exists on which outcome measures are best, and clinicians cite several barriers to their use. Single Assessment Numerical Evaluation (SANE) may provide meaningful outcome information while lessening the time burden associated with other patient-oriented measures.Hypothesis:The SANE and International Knee Documentation Committee (IKDC) scores would be strongly correlated in a cohort of young active female patients with knee injuries from preinjury through 1-year follow-up and that a minimal clinically important difference (MCID) could be calculated for the SANE score.Study Design:Observational prospective cohort.Methods:Two hundred sixty-three subjects completed SANE and IKDC at preinjury by recall, time of injury, and 3, 6, and 12 months postinjury. Pearson correlation coefficients were used to assess the association between SANE and IKDC. Repeated-measures analysis of variance was used to determine differences in SANE and IKDC over time. MCID was calculated for SANE using IKDC MCID as an anchor.Results:Moderate to strong correlations were seen between SANE and IKDC (0.65-0.83). SANE, on average, was 2.7 (95% confidence interval, 1.5-3.9; P < 0.00) units greater than IKDC over all time points. MCID for the SANE was calculated as 7 for a 6-month follow-up and 19 for a 12-month follow-up.Conclusion:SANE scores were moderately to strongly correlated to IKDC scores across all time points. Reported MCID values for the SANE should be utilized to measure meaningful changes over time for young, active female patients with knee injuries.Clinical Relevance:Providing clinicians with patient-oriented outcome measures that can be obtained with little clinician and patient burden may allow for greater acceptance and use of outcome measures in clinical settings.

System Physical Function (PROMIS-PF) measure based on rising popularity and the amount of research dedicated for its use in a variety of knee conditions. A basic summary of the properties of the different measures is displayed in table 1. Psychometric data pertaining to the floor and ceiling effects, validity, reliability, responsiveness, and minimum clinically important difference of each patient reported outcome is displayed in table 2. Floor and ceiling effects were considered to be absent if no participants scored the bottom or top score, respectively, and acceptable if <15% of the cohort scored the bottom or top score, respectively. Validity was measured by assessing content, face, and construct validity. Content validity was present if patients were involved in development. Face validity was present if expert reviewers made a similar assessment and considered the measured items adequate. Construct validity was considered adequate if expected correlations were found with existing measures that assess similar (convergent construct validity) and dissimilar (divergent construct validity) constructs. Internal consistency was considered adequate if Cronbach's alpha was at least 0.7 (1), and test-retest (intrarater) reliability was adequate if the intraclass correlation coefficient was at least 0.8 for groups and 0.9 for individuals. Responsiveness was determined with a measures ability to detect change over a period of time or intervention. Minimum clinically important difference is the amount of change of a patient-reported outcome that represents a meaningful change to the patient. Since 2011, there have been numerous studies evaluating the psychometric properties of the above studies. There has also been ample research assessing the utility and psychometric properties of the PROMIS-PF function. Extensive work has been performed to add available translations and culturally adapted versions of the above measures. Our review summarizes the available information about how these measures perform for different patient populations in different settings.

Clinical outcomes of hemiarthroplasty and biological resurfacing in patients aged younger than 50 years

Objectives:Lateral epicondylitis is the most common condition affecting the elbow however conservative treatment for the condition remains controversial. Various approaches have been described including braces, physical therapy, corticosteroid injections, and platelet-rich-plasma (PRP) injections. PRP is taken from a centrifuged blood sample and consists mainly of platelets and growth factors. Although research surrounding injections in lateral epicondylitis continues to evolve, randomized controlled trials have shown that PRP injections are associated with decreased pain at two-year follow-up. Visual analog scale (VAS) pain scores and other patient reported outcome measures (PROMs) such as Disabilities of the Arm, Shoulder, and Hand (DASH) have been used previously; however, no studies to date have used the Single Assessment Numeric Evaluation (SANE). It was hypothesized that patients would report improvements in pain and function at four weeks and four months after PRP injection. The primary outcomes were SANE and VAS pain scores. The secondary aim was to determine a minimum clinically important difference (MCID) value for SANE for this procedure.Methods:This was a retrospective review of a prospectively collected PROM database from 2021-2023. All patients who received a PRP injection for lateral epicondylitis were included in this study. Patients were excluded if they were missing baseline SANE or VAS pain scores, received an injection anywhere besides the common extensor tendon origin, or had overlapping conditions such as cervical radiculopathy, cubital tunnel or carpal tunnel syndrome. Baseline patient characteristics including sex, age, smoking history, history of depression or anxiety, disease chronicity, and hand dominance were collected. Previous history of physical therapy, corticosteroid injection, PRP injection, and procedure characteristics including milliliters (ml) of PRP injected and number of fenestrations were also collected. All PRP injections were ultrasound guided and conducted using the health-system standardized protocol with leukocyte-rich plasma. Primary outcomes included SANE and VAS pain scores at baseline, four weeks, and four months post-injection. MCID was calculated using the distribution-based method, calculated as half of the standard deviation of the change in SANE score. Additional outcomes included if the patient experienced any adverse events following injection, underwent subsequent injection within the study period.Results:A total of 36 patients met criteria for analysis. More than half the patients were male (n=20, 55.6%), and the average age was 50.15±9.31 years. Only 5.6% of patients were current smokers (n=2). Fifteen patients (41.7%) had histories of depression, and 10 patients (27.8%) had histories of anxiety. Most patients received an injection after experiencing symptoms for 10.62±9.56 months on average. The majority of patients previously tried or were concurrently going to physical therapy (n=28, 77.8%). Fourteen patients (38.9%) had received a previous corticosteroid injection, and five patients (13.9%) had received a previous PRP injection.The injection procedure typically consisted of 2.36±0.66 ml of PRP with 5.74±3.03 fenestrations. Most injections were done in the dominant arm (n=28, 77.8%). A total of six patients went on to have a repeat injection (16.7%). There were five patients who experienced increased post-procedure pain (13.9%) and one who experienced nerve irritation (2.8%). All adverse events eventually resolved.SANE scores at baseline, four-week, and four-month follow-up were 53.06±23.28, 57.22±27.32, 65.19±27.07. The difference between baseline and follow-up at four weeks was not statistically significant (p=0.245), but the follow-up scores at four months were found to be statistically higher than baseline scores (p=0.044). The average changes from baseline to four weeks and baseline to four months were 7.04±30.77 and 15.50±28.13, respectively. VAS pain scores at baseline, four-week, and four-month follow-up were 5.14±2.10, 4.25±2.66, 3.17±2.81. Follow-up scores at four weeks and four months were found to be statistically lower than baseline scores (p=0.006, p=0.003). The average changes from baseline to four weeks and baseline to four months were -1.29±2.29 and -2.44±2.99, respectively. A history of prior corticosteroid injection was not significantly associated with changes in SANE scores at four weeks or four months after PRP injection (p=0.149, p=0.602, respectively). The SANE MCID values at four weeks and four months were 15.39 and 14.07, respectively. Of those patients who reported, 44.4% met the four-week value and 37.5% met the four-month value.Conclusions:Patients after PRP injection for lateral epicondylitis demonstrated increased SANE scores at four months and decreased VAS pain scores at four weeks and four months. The change in SANE scores at four weeks was not statistically significant. These results may indicate that there are greater pain reducing effects as well as milder extremity functionality improvement effects associated with PRP injection. This may be in part due to the inherent nature of the disease with the more prevalent symptom being pain over loss of function. PRP injections are a safe and effective conservative treatment method for reducing pain symptoms and increasing functionality in patients with lateral epicondylitis. Physicians should discuss patient expectations for improvement during the early post-injection period.

Background: Anterior cruciate ligament (ACL) injury is a persistent orthopaedic condition that affects a wide spectrum of people. ACL reconstruction (ACL-R) stands out as the primary treatment option. Graft fixation with suture buttons and interference screws has proven to be a highly successful and reliable method for ACL-R. In this context, our research aims to assess the safety and functional outcomes of patients who underwent arthroscopic ACL-R using the Sironix suture button and interference screw. Methods: This was a retrospective observational study. Patients who underwent arthroscopic ACL-R using Sironix suture button and interference screw (January 2018-March 2022) were included in the study. Functional outcomes of patients were evaluated using the international knee documentation committee (IKDC) assessment, the Tegner activity scale (TAS), the Lysholm knee scoring scale, the modified knee injury and osteoarthritis outcome score (KOOS) quality of life subscale, and the single assessment numerical evaluation (SANE) score. Adverse events, if any, were recorded. Results: All patients achieved excellent outcome measures for IKDC, Tegner, Lysholm, KOOS, and SANE scores. The mean (SD) IKDC score was 88.76 (7.16), Tegner activity score was 5.9 (1.13), while the Lysholm score was 96.9 (6.56). The overall KOOS score was 93.7 (7.52), and the overall SANE score for the affected joint was 94.5 (7.22). Conclusions: Arthroscopic ACL-R using Sironix implants (Helysis titanium interference screw, Helysis PLDLA+β-TCP interference screw, Infiloop fixed loop UHMWPE suture titanium button, Proloop adjustable loop UHMWPE suture Titanium button, and Titanium suture disc) demonstrated safety and good functional outcomes.

Background: Previous studies have examined the relationship between patient resilience and functional outcome scores after anterior cruciate ligament reconstruction (ACLR). However, past studies have failed to explore the longitudinal relationship between preoperative resilience and functional outcomes 2 years after ACLR. Purpose: To evaluate the relationship between preoperative patient resilience and functional outcomes 2 years after ACLR. Study Design: Cohort study; Level of evidence, 3. Methods: Patients were identified who underwent ACLR for anterior cruciate ligament tears between January and June 2020 at a single institution. Those who completed the Brief Resilience Scale preoperatively as part of routine patient questionnaires were considered for inclusion. Patients were contacted a minimum of 2 years after ACLR to complete the short form of the Knee injury and Osteoarthritis Outcome Score (KOOS-JR), Single Assessment Numeric Evaluation (SANE), International Knee Documentation Committee (IKDC) Subjective Knee Form, and visual analog scale (VAS). Outcomes were compared among patients with low resilience (LR), normal resilience (NR), and high resilience (HR), as defined in a previous study.23 Results: A total of 81 patients were included in the final analysis, with 14 patients in the low preoperative resilience group, 54 in normal, and 13 in high. The mean age of the cohort was 32.0 years, and there were no significant differences in age, sex, race, graft type, or psychiatric comorbidities among the resilience groups. Significantly increased postoperative KOOS-JR scores were observed in patients in the HR group as compared with those in the NR and LR groups (94.8, 86.7, and 79.6, respectively; P = .031). There were also significantly increased postoperative SANE scores in patients in the HR group versus those in the NR and LR groups (92.3, 83.5, and 69.2; P = .012). Patients with high preoperative resilience achieved the IKDC Patient Acceptable Symptom State at significantly higher rates (P = .003). No significant differences were observed in postoperative VAS (P = .364), IKDC (P = .072), or change in IKDC (P = .448) over time among resilience groups. Postoperatively, 30 patients (37.0%) changed resilience groups, with 13 moving down and 17 moving up in category (low, n = 12; normal, n = 55; high, n = 14). Conclusion: Preoperative resilience correlated with KOOS-JR and SANE scores 2 years after ACLR but did not correlate with VAS, IKDC, or change in IKDC over the same period. Resilience was not static, with changes in resilience observed from initial to final evaluations. Resilience is not a strong predictor of postoperative patient-reported outcomes after ACLR.

Objectives: Rotator cuff tears (RCTs) are the number one cause of shoulder pain and are becoming increasingly common as the population ages. The increasing incidence of RCTs present a significant economic burden, with shoulder pain being the No. 1 cause of disability in the United States. Repair of RCTs, in return, result in a cumulative $3.4 billion savings annually in the United States. Historically, follow-up for rotator cuff repair (RCR) mirrors that of hip and knee arthroplasty, with minimum of 2-year outcomes reported in most peer-reviewed studies. Recent literature, however, demonstrates no significant increase in clinically significant improvement after 6 months regarding functional outcomes and patient-reported outcomes (PROs) such as American Shoulder and Elbow Surgeons Shoulder Score (ASES), visual analog scale (VAS), and Disabilities of the Arm, Shoulder, and Hand (DASH) scores among others. The purpose of this study is to demonstrate degradation of outcome improvement in patient-reported outcomes after 1-year follow-up of RCR. We hypothesize that there will be no clinically significant increase in Single Assessment Numeric Evaluation (SANE) scores after 1 year postoperatively. The primary outcome of interest is change in SANE score over the 2-year episode of care. Methods: All patients that underwent primary RCR within a single health care system were eligible for inclusion in this study. Exclusion criteria included history of surgery on the affected shoulder, incomplete PROs at baseline, 1 year, or 2 years postoperatively, and concomitant fractures about the affected shoulder. Patient demographics, injury characteristics, and operative technical characteristics were obtained through review of the patients’ electronic medical records and operative reports. PROs included SANE, ASES, and VAS scores and were collected prospectively, then stored in a HIPAA-compliant database until reviewed retrospectively for this study. An anchor-based minimum clinically important difference (MCID) was calculated for the study cohort at 1 and 2 years postoperatively and was anchored on a 1-point increase in the Patient-Reported Outcomes Measurement Information System global 10 quality of life question. The primary outcomes of interest are baseline (preoperative), 1-year, and 2-year SANE scores. Secondary outcomes of interest included rates of symptomatic retear, reoperation, and revision. Statistical analysis was performed with a statistical analysis software (Intellectus). Analyses included descriptive statistics, t tests, chi-square tests of independence, Fischer exact tests, and analyses of variance, as appropriate. Statistical significance was defined as an alpha value of p ≤ 0.05. Results: A total of 495 patients met criteria for inclusion in the study (Table 1). The average age of the study population was 61.5 ± 8.4 years old, and the average body mass index (BMI) was 29.9 ±5.5. Most patients were men (287, 58.0%). A total of 24 patients were under workers’ compensation. Other medical comorbidities of interest included diabetes (74, 15.0%), depression (85, 17.2%), anxiety (74, 15.0%), and rheumatoid arthritis (6, 1.2%). Just over half of patients had chronic tears as described by the surgeon in clinical notes or operative reports (259, 52.3%), and most patients had full-thickness tears documented in the operative report (402, 81.2%). The most common adjuvant procedures included subacromial decompression (SAD) (419, 84.6%), biceps tenodesis (211, 42.6%) and distal clavicle excision (DCE) (133, 26.9%). Baseline SANE scores for the study cohort averaged 40.8 ± 20.3 with a subsequent of 43.4 within the first year postoperatively, bringing the 1-year SANE average to 84.1 ± 196 (p &lt; 0.001). After the 1-year follow-up, however, there was small but statistically significant change in SANE scores with the 2-year SANE scores averaging 87.5 ± 18.1, p &lt; 0.001) (Figure 1). One-year anchor-based MCID for SANE was found to be 45.5, with 238 (48.1%) meeting this MCID. At 2-years, 213 patients (43.0%) met the MCID of 50.6. Conclusions: Over the 2-year episode of care following primary RCR, patients saw an overall increase in SANE of 46.8. Even after the 1-year follow-up, patients continued to see statistically significant increases in SANE scores; however, they did not see clinically significant increase in PROs, as demonstrated by fewer patients meeting the 2-year MCID compared with the 1-year MCID. [Figure: see text]

Background: Platelet-rich plasma (PRP) is increasingly used for the injection treatment of knee osteoarthritis (OA). However, the role of leukocytes contained in PRP is controversial, with some preclinical studies suggesting detrimental effects and others emphasizing their contribution in secreting bioactive molecules. Purpose: To compare the safety and effectiveness of leukocyte-rich PRP (LR-PRP) and leukocyte-poor PRP (LP-PRP) for the treatment of knee OA. Hypothesis: That leukocytes could influence results both in terms of adverse events and clinical outcomes. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This double-blind randomized controlled trial included 132 patients with Kellgren-Lawrence grade 1-3 knee OA who were randomized to a 3-injection cycle of either LR-PRP or LP-PRP. Patients were prospectively assessed at baseline and at 2, 6, and 12 months with subjective evaluations comprising the International Knee Documentation Committee (IKDC) subjective score, the KOOS (Knee injury and Osteoarthritis Outcome Score), the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), the visual analog scale for pain, the EuroQol–visual analog scale, the EuroQol–5 dimensions, and the Tegner activity scale. Objective evaluations consisted of the IKDC objective score, active/passive range of motion, and circumference of the index and contralateral knees. Patient judgment of the treatment was recorded as well as adverse reactions and failures. Results: An overall improvement in subjective and objective outcomes was documented, with no differences between the 2 groups, except for the improvement in the IKDC subjective score at 2 months, which was greater for the LR-PRP group compared with the LP-PRP group (14.8 ± 14.8 vs 8.6 ± 13.3, respectively; P = .046), as well as for active (P = .021) and passive (P = .040) ROM of the index knee at 6 months, showing statistically significant higher values in the LP-PRP group; and for quadriceps circumference of the index (P = .042) and contralateral (P = .045) knees at 12 months, which were significantly greater in the LR-PRP group. The IKDC subjective score improved from 42.5 ± 17.6 at baseline to 55.6 ± 21.4 at 12 months for the LR-PRP group (P < .0005) and from 45.7 ± 16.4 to 55.3 ± 20.4 for the LP-PRP group (P = .001). No differences in terms of patient treatment judgment were observed at all follow-up time points. No severe adverse events related to the treatment were reported, but some mild adverse events related to the treatment were observed: 16 in the LR-PRP group and 17 in the LP-PRP group. Treatment failed in 5 patients in the LR-PRP group and 2 in the LP-PRP group. Conclusion: This double-blind randomized controlled trial demonstrated that leukocytes did not affect the safety and efficacy of intra-articular PRP injections for the treatment of patients with knee OA. Both LR-PRP and LP-PRP demonstrated comparable clinical outcomes at all follow-up time points, without showing differences in subjective and objective outcomes or in adverse events and treatment failures. Registration: NCT04187183 (ClinicalTrials.gov).

Early repair of traumatic rotator cuff tears improves functional outcomes.