Firm Endpoint Research Articles

Biological Versus Nonbiological Reconstruction of the Ulnar Collateral Ligament of the Thumb Metacarpophalangeal Joint: A Retrospective Study

The purpose of this study was to compare clinical and radiologic outcomes of biological ligament reconstruction (BLR) versus nonbiological ligament reconstruction (NBLR) for chronic injuries involving the ulnar collateral ligament of the thumb's metacarpophalangeal joint. Forty-two patients who underwent static BLR (n= 24) or NBLR (n= 18) were included in this retrospective analysis. Preoperative, postoperative, and contralateral thumb measurements (clinical evaluation, radiographs, and subjective outcome questionnaires) were compared over a mean of 38 months of follow-up. Average postoperative thumb metacarpophalangeal and interphalangeal joint ranges of motion were 2° to 54° and 0 to 71°, respectively, for BLR and 0° to 58° and 0° to 71°, respectively, for NBLR. Average grip and pinch strengths, relative to the unaffected hand, were 102% and 84% versus 103% and 89%, respectively. All patients demonstrated stability with a firm end point, compared with the unaffected thumb. The average Quick Disabilities of the Arm, Shoulder, and Hand score among all patients was 12 for the disability/symptom module, 0 for the sports module, and 17 for the work module. Stiffness was reported among four patients, and no patient sustained wound-related issues or other complications. Nonbiological ligament reconstruction of the thumb ulnar collateral ligament generates short-term outcomes comparable with those of BLR, potentially allowing for expedited recovery and rehabilitation. Therapeutic IV.

The Ulnar Olecranon-Coronoid Notch Angle Affects Terminal Elbow Extension in Children and Adolescents.

Limitations to terminal elbow extension (TEE) in pediatric populations have been commonly associated with the degree of ligamentous laxity and not bony factors. Ligamentous laxity, quantified through the Beighton score, is criticized for unreliably assessing joint mobility. This study aims to show that the olecranon-coronoid notch angle (OCNA) affects TEE in healthy children and adolescents. A retrospective study of 711 pediatric patients treated for upper extremity and shoulder injuries was cross-sectionally studied at 2 tertiary centers from 2014 to 2021. Radiographs were used to measure the OCNA, humerocondylar angle, proximal anterior ulnar angle, and the presence of secondary centers of ossification. A 2-axis goniometer measured clinical TEE to a firm endpoint. The statistical analysis studied the relationships between OCNA and TEE and the effect that age and sex have on these measurements. Increased TEE was associated with increased OCNA (P<0.001) when accounting for age and sex. The average OCNA was 30.0 degrees (7.5 degrees), and the average TEE was 5.6 degrees (8.0 degrees). There was a difference in OCNA between subjects who had elbow hypoextension, normal TEE, and elbow hyperextension (P<0.001). The most common injuries were distal radius fractures (182, 26%), elbow sprains and contusions (111, 16%), distal both bone forearm fractures (95, 14%), single or both bone shaft fractures (77, 11%), and supracondylar fractures (74, 11%). These results show that the orientation of the opening of the olecranon-coronoid notch influences the arc of TEE motion in a healthy pediatric population. The notch restrains TEE by activating the bony block mechanism between the olecranon apophysis and the olecranon fossa. The measurement of the OCNA can serve as a reproducible and quantitative method to predict hypomobility to hypermobility of TEE motion. Prognostic study: Level II.

Medial Patellofemoral Reconstruction With a Hamstring Allograft

Background: Lateral patellar instability is common in young, active patients. Patients who fail conservative treatment may benefit from medial patellofemoral ligament (MPFL) reconstruction. Indications: Recurrent lateral patellar instability. Technique Description: Examination assesses patellar translation, eversion and range of instability. Diagnostic arthroscopy is performed for loose bodies, cartilage damage, trochlear dysplasia, and tracking. A longitudinal incision is made from superomedial to mid-body of the patella. The plane between the capsule and retinaculum is developed for palpation of the medial epicondyle and adductor tubercle. Electrocautery and rongeur are used to create a trough on the patella from centromedially to superomedially. Two suture anchors are placed at the proximal and distal trough. Fluoroscopy is utilized to identify Schöttle point with a perfect lateral radiograph. A 3-centimeter incision is made, and blunt dissection connects the 2 incisions in the developed plane. A guidepin is advanced at Schöttle point, and suture anchor sutures are shuttled through the plane, posterior to the guidepin. There should be loosening of tension with knee flexion. A semitendinosus allograft is whipstitched with terminal tapering. The whipstitched end is tunneled around the guidepin and brought back to the patella, so that both ends have an excess of 20 to 25 millimeters, and excess graft is trimmed from the free end prior to whipstitching. The doubled graft is sized. The midportion of the tendon is tagged and passed through both anchors. The graft is tensioned to the patellar trough and the graft ends are advanced through the developed plane. The femoral tunnel is reamed, and the graft is tensioned into the tunnel after nitinol wire placement with the knee in full extension. Isometry and lateral patellar translation are assessed, aiming for 1 quadrant with firm endpoint. The patella is proximalized and the tensioned graft is secured with an interference screw. Results: MPFL reconstruction is successful for the majority of patients, with 1.2% reporting instability, 3.6% apprehension, and 3.1% reoperation. Possible complications include patellar fracture, patellofemoral pain, and knee stiffness (loss of range of motion). Discussion/Conclusion: Lateral patellar instability is common, and MPFL reconstruction is typically successful for the majority of patients.

Radius distraction during volar plating of distal radius fractures may improve distal radioulnar joint stability at minimum 3-year follow-up: a retrospective case series study

BackgroundThe surgical technique of radius distraction for stabilization of distal radioulnar joint (DRUJ) if intraoperative DRUJ instability was found after the fixation of distal radius fracture has been previously described, but this surgical technique lacks clinical and radiographic effect in minimal 3 years follow-up. We therefore evaluated the clinical outcome and radiographic results of radius distraction in minimal 3 years follow-up as long-term evaluation.MethodsWe reviewed the case series of distal radius fracture with concomitant DRUJ instability receiving radius distraction from the senior author over a 5-year period (January 1st, 2013, to June 30th, 2017) retrospectively. Radius distraction during volar plating was performed by moving the volar plate distally via compression screw loosening/fastening to achieve firm endpoint on the dorsopalmar stress test. The evaluations of radiographic, including bone union time and ulnar variance, and clinical outcomes, including grading of DRUJ instability, NRS of wrist pain, DASH score, MMWS score, and range of motion of operated wrist at final follow-up, were performed at clinic as minimum 3-year follow-up; a total 34 patients had been evaluated.ResultsAt minimal post-operative 36 months follow-up, all cases demonstrated acceptable wrist range of motion with stable DRUJs, low NRS of wrist pain (0.6, SD 0.7), and satisfactory DASH score (mean 9.1, SD 6.2) and MMWS score (mean 87, SD 10). There were no cases suffering from nonunion of distal radius. The mean ulnar variance of injured wrist and uninjured wrist were -1.2 mm and 0.2 mm, respectively (SD 1.0 and 0.6) with significant statistical difference.ConclusionsRadius distraction during volar fixation of distal radius fracture should be considered if DRUJ instability was found by the dorsopalmar stress test intraoperatively, and the long-term DRUJ stability could be achieved by maintenance of normal-to-negative ulnar variance, with decreased wrist pain and satisfactory function outcome.Level of EvidenceTherapeutic Level IV

Clinical Outcomes of Arthroscopic Debridement for Lateral Epicondylitis with Partial Injury of the Lateral Collateral Ligament Complex.

BackgroundLateral collateral ligament injuries may occur in patients with chronic lateral epicondylitis. The present study aimed to compare the clinical outcomes of arthroscopic debridement between patients with chronic lateral epicondylitis combined with a partial ligament injury and those without a ligament injury.MethodsBetween 2016 and 2018, patients who underwent arthroscopic debridement for lateral epicondylitis were evaluated. Partial injury to the lateral collateral ligament was defined as discontinuity or thinning with increased signal of the lateral ligament on magnetic resonance imaging and laxity with a firm endpoint in the varus or posterolateral rotatory stress test. Arthroscopic debridement was performed when there was no apparent instability in the stress test under fluoroscopic guidance after anesthesia. Patients with a ligament injury were compared with those without a ligament injury in terms of physical examination (varus stress test and posterolateral rotatory drawer test), pain visual analog scale, Mayo elbow performance score, and quick disabilities of the arm, shoulder and hand score.ResultsThere were 38 patients in the intact ligament group and 15 patients in the partial ligament injury group. There were 23 men and 30 women, and the mean patient age was 50 years (range, 27–77 years). The mean follow-up period was 30 months (range, 24–49 months). Instability was not observed in both groups at the last follow-up, and clinical scores improved significantly after surgery. Postoperative results did not show significant difference between the two groups. One patient in the partial injury group underwent revision open debridement owing to persistent pain.ConclusionsThe clinical outcomes of arthroscopic debridement for lateral epicondylitis did not show significant differences between patients with a partial ligament injury and those without a ligament injury.

ACL reconstruction with lateral extra-articular tenodesis using a continuous graft: 10-year outcomes of 50 cases

BackgroundPersistence of pivot shift is the main problem after isolated intra-articular anterior cruciate ligament (ACL) reconstruction. Adding lateral extra-articular tenodesis (LET) to the ACL procedure increases the knee's stability by controlling rotational laxity. The aim of this study was to evaluate the long-term clinical and radiological outcomes of combined ACL reconstruction with LET using a continuous hamstring graft as a first-line procedure. Material and methodsFifty patients were reviewed at 10 years postoperative. Subjective outcome scores –IKDC, Lysholm, KOOS and Tegner– were collected. A clinical and radiological assessment was done. The knees’ anteroposterior laxity was measured with a rollimeter. ResultsThe mean IKDC subjective score was 85.5, the mean Lysholm score was 90.2 and 80% of patients had a score graded as good or very good. No pivot shift was present in 94% of patients and there was a firm endpoint in the Lachman test in 86% of patients. There was a flexion deficit>5° in 5 patients and an extension deficit of 10° in one patient. Most patients (56%) had resumed their physical activities at the same level as before the surgery. Signs of osteoarthritis were found in 26% of patients (16% were Ahlback stage 1 and 10% were stage 2). There was only one graft failure. These good outcomes are consistent with other published studies on combined ACL-LET. There was neither significant stiffness, nor a higher rate of secondary osteoarthritis relative to ACL reconstruction only, particularly in the lateral tibiofemoral compartment. ConclusionAdding primary LET to ACL reconstruction improves control of rotational laxity over time without increasing the complication rate. Level of evidenceIV, retrospective study without control group.

Thumb Ulnar Collateral Ligament Repair with Suture Tape Augmentation.

Background: The purpose of this study is to describe our technique of thumb ulnar collateral ligament (UCL) repair with suture tape augmentation and to evaluate the short-term outcomes in our initial series of patients treated with this method of repair. Methods: Patients with minimum one-year follow up after isolated UCL repair with suture tape augmentation were contacted for clinical evaluation, radiographs, and postoperative outcome questionnaires, including the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire and study-specific questions. Thirteen of 15 (87%) consecutive patients who were treated using this method of repair were available for follow-up, 9 with acute tears and 4 with chronic tears. Results: Average post-operative thumb metacarpophalangeal (MCP) and interphalangeal (IP) joint range-of-motion (ROM) was 0-57.5° and 0-71°, respectively, for chronic tears and 2.2-53.9° and 0-71°, respectively, for acute tears. Average grip and pinch strength relative to the unaffected hand was 102% and 84%, respectively, among patients with chronic tears and 103.3% and 88.7%, respectively, among those with acute tears. All patients demonstrated stability with a firm endpoint, relative to the unaffected thumb. The average QuickDASH score among all patients was 11.9 for the disability/symptom module, 0 for the sport module and 16.5 for the work module. Stiffness was reported among 4 patients and no patient suffered wound-related issues or other complications. Conclusions: Thumb UCL repair with suture tape augmentation demonstrates short-term outcomes comparable to what has been reported for other methods of repair. It may potentially allow for an expedited recovery and rehabilitation process.

The Comorbidity conception of somatic diseases in cardiology practice.

The article review discusses the comorbidity of somatic diseases in cardiology practice. There are discussed the definition and formation history of comorbidity theory prevalence and options for the development of comorbidity. In the article also is analyzed the prevalence of comorbidity in the population and cohorts of individuals with various diseases. The commonality of risk factors for chronic non-inflectional diseases is an important prerequisite for the development of comorbidity. This study considers various options for the comorbidity development. We have to apply the concept in practical health care create. We also have to create the available tools to determine the prognostic of comorbidity of somatic diseases and. In the article are presented three methods for assessing the prognosis and survival in case of comorbidity of somatic diseases. There are considered unified views on the tactics of treatments, prevention of comorbidity and high risk of complications. At the moment the data is being accumulated on the benefits of poly pills tactics treatment. However, studies with firm endpoints are few in number to date. We have to combine the medicine with different mechanisms of action that have an evidence base for achieving target levels of individual indicators requires. The authors propose algorithms for managing patients with comorbid pathology, for which they have developed schemes of actions from diagnostics to monitoring the main indicators for evaluating the effectiveness of therapeutic interventions and preventive measures. &nbsp; &nbsp

The Pull Test: A Dynamic Test to Confirm Hip Microinstability

PurposeTo define a distraction distance (pull length) cut-off that would differentiate those patients with hip microinstability and those without the disorder, called the Pull-Out Test.MethodsIn total, 100 consecutive patients undergoing hip arthroscopy were included in the study. Patients were separated into a hip microinstability group (HMI) and non-hip microinstability group (NHI) based on the results of Beighton's score, the abduction–extension–external rotation test, hip extension–external rotation examination, and the prone instability test. Inclusion criteria were patients with an magnetic resonance imaging-proven labral tear who did not respond to conservative treatment and underwent hip arthroscopy. Exclusion criteria included those patients undergoing revision hip arthroscopy, had a previous surgery on the ipsilateral hip, or had severe arthritis in the hip. The Pull-Out Test was performed before surgery with the hip in 30° of abduction and the foot in 30° of external rotation. A blinded examiner places gross axial traction on the leg until a firm end point is reached. The distraction distance between the femoral head and acetabulum is the pull length.ResultsIn total, 32 patients made up the HMI group whereas 68 patients were in the NHI group. The average pull length for the NHI group was 0.9 ± 0.1 cm and 1.7 ± 0.4 cm for the HMI group (P < .001). Subtracting the standard deviation from the HMI group average, when defined a cut off for hip microinstability as 1.3 cm. Using this value, we found the Pull-Out Test to have a sensitivity of 0.91 and specificity of 0.96. The positive predictive value for the Pull Test was 0.91 and the negative predictive value 0.97.ConclusionsThe Pull-Out Test is a useful test in identifying and confirming the presence of hip microinstability in patients undergoing hip arthroscopy. A pull-length of 1.3 cm or greater is consistent with the presence of microinstability with a specificity of 94% and a sensitivity of 96%.Level of EvidenceLevel IV, diagnostic, case-control study.

Evaluation of event-free survival as a robust end point in untreated acute myeloid leukemia (Alliance A151614)

AbstractEvent-free survival (EFS) is controversial as an end point for speeding approvals in newly diagnosed acute myeloid leukemia (AML). We aimed to examine the robustness of EFS, specifically timing of complete remission (CR) in defining induction failure and impact of hematopoietic cell transplantation (HCT). The study included 1884 untreated AML patients enrolled across 5 trials conducted through Alliance for Clinical Trials in Oncology using anthracycline and cytarabine induction chemotherapy. EFS was defined as time from randomization/registration to induction failure, relapse, or death. Three definitions of induction failure were evaluated: failure to achieve CR by 60 days after randomization/registration, failure to achieve CR by the end of all protocol-defined induction courses, and failure to achieve CR by the end of all protocol-defined treatment. We considered either censoring or no censoring at time of non–protocol-mandated HCT. Although relapse and death are firm end points, the determination of induction failure was not consistent across studies. There was minimal impact of censoring at HCT on EFS estimates; however, median EFS estimates differed considerably based on the timing of CR in defining induction failure, with the magnitude of difference being large enough in most cases to lead to incorrect conclusions about efficacy in a single-arm trial, if the trial definition was not consistent with the definition used for the historical control. Timing of CR should be carefully examined in the historical control data used to guide the design of single-arm trials using EFS as the primary end point. Trials were registered at www.clinicaltrials.gov as #NCT00085124, #NCT00416598, # NCT00651261, #NCT01238211, and #NCT01253070.

Midterm Outcomes following Acute Repair of Grade III Distal MCL Avulsions in Multiligamentous Knee Injuries.

There is limited evidence guiding management of medial collateral ligament (MCL) avulsions or functional disruptions distal to the medial joint line. This study aims to determine outcomes of a series of patients with grade III distal MCL injuries managed with acute surgical repair. Patients with grade III, distal MCL injuries, with or without multiligament involvement were identified. Demographic, clinical examination, and midterm patient-reported outcomes (PRO) data were collected. Clinical follow-up included physical examination and ligamentous stress testing at a minimum of 6 months. PROs included Lysholm's knee scoring scale, Tegner's activity score, and subjective International Knee Documentation Committee (IKDC) scores at minimum of 2 years follow-up. Of the 24 eligible patients, outcomes data were available for 20 (83%). Of the 20 included patients, 16 had a concomitant anterior cruciate ligament (ACL) injury, 3 had ACL and posterior cruciate ligament (PCL) injuries, and 1 had an isolated MCL injury. Mean time from injury to surgery was 5 weeks. At mean clinical follow-up of 20.3 months, all patients showed valgus stability and satisfactory range of motion (ROM). Anteroposterior stability was normal in all but one patient who demonstrated a 2+ posterior drawer but with firm end points. At a mean follow-up of 5.7 years for PROs, mean Lysholm's score was 91.5 (standard deviation [SD] = 12.2), median Tegner's activity score was 7 (range, 4-9), and mean subjective IKDC score was 88.8 (SD: 9.9). The surgical repair of grade III distal MCL injuries delivered satisfactory clinical and functional outcomes. Future comparative studies with larger patient samples are needed.

Medial Patellofemoral Ligament Reconstruction: A Comparison of Single-Bundle Transpatellar Tunnel and Double-Anchor Anatomic Techniques for the Treatment of Recurrent Lateral Patellar Dislocation in Adults

To compare the stability and clinical outcomes of 2 medial patellofemoral ligament reconstruction (MPFLR) techniques for the treatment of recurrent lateral patellar dislocation in adults. Ninety-one patients with recurrent patellar dislocation were randomly divided into 2 groups, undergoing either the traditional single-bundle transpatellar tunnel technique (group A) or the double-anchor anatomic reconstruction technique (group B). Preoperatively and at follow-up, the patellar position and rotation were evaluated by computed tomography with the congruence angle, lateral patellar angle, patellar tilt angle, and lateral patellar translation; the subjective symptoms and functional outcomes were evaluated with Kujala, Lysholm, Tegner, and International Knee Documentation Committee subjective scores. Clinical examinations were also performed, and redislocations or episodes of instability were recorded. Patients were followed up for a mean period of 41.11 ± 7.40months (range, 29-62months). At the final point, no recurrent patellar dislocations occurred, except in 4 patients with instability symptoms in group A; however, no significant difference between the 2 groups was seen (χ2= 2.503, P= .114). The measurement results from computed tomography decreased significantly to the normal range, and no significant difference was found between the 2 groups except for the lesser patellar tilt angle in group B (t= 2.175, P= .030). The clinical examination improved significantly, no patient exhibited a positive apprehension test in either group, and the number of patients with abnormal lateral patellar translation grade and firm end point showed no statistically significant differences between the 2 groups (P > .05). All score systems significantly improved with no significant difference between the 2 groups except for the higher Kujala score (t=-40.635, P= .001) and International Knee Documentation Committee score (t=-33.823, P= .003) in group B. Both MPFLR techniques achieved goodresults in the treatment of patellar dislocation. Compared with the single-bundle transpatellar tunnel technique, the double-anchor anatomic MPFLR technique may be more effective with a more congruous patellofemoral joint and better knee function. Level II, prospective comparative study.

Outcome of isolated posterior cruciate ligament reconstruction at mean 6.3-year follow up: a consecutive case series

ABSTRACTObjectives: There is a paucity of reporting on surgical outcomes of isolated posterior cruciate ligament reconstruction (PCLR). We hypothesize that isolated PCL injuries failing nonoperative treatment achieve good outcomes and are able to return to sport following PCLR.Methods: A retrospective analysis was performed to identify patients with isolated PCL injuries that underwent reconstruction between 2001 and 2014. Patients with multi-ligamentous injury or another concomitant knee pathology were excluded. Medical records were reviewed for demographic, clinical and operative data. Patients were contacted for administration of a telephone-based questionnaire which included the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation form, Lysholm-Tegner scales, Marx activity scale (MAS), return to sport status, and patient satisfaction instruments.Results: A total of 15 isolated PCL reconstructions in 14 patients with a mean age of 27.5 years (range 17–43) met the study inclusion criteria; mean follow up was 6.3 years (range 1.4–15.2). Pre-operatively, the primary complaint was knee instability in all patients; on physical examination, lack of a firm end point during posterior drawer testing was found in 93% (14/15) of the knees. In total, 12 of 15 knees underwent transtibial, single-bundle PCLR and three of 15 underwent tibial inlay, double bundle PCLR. Graft types included: quadriceps autograft (7/15), Achilles allograft (6/15), and hamstring autograft (2/15). There were no graft failures in our patient cohort. At most recent follow up the mean scores respectively on the IKDC form, Lysholm-Tegner scales and MAS were (standard deviation): 77.3 (16.5), 83.1 (17.9), 6.13 (2.6), and 7.1 (6.0). All fourteen patients were athletes prior to their injury and 79% (11/14) returned to sport and overall patient satisfaction was 9.2/10.Conclusions: Isolated PCLR provides good outcomes at mean medium-term follow up with restoration of function, high rate of return to sport and overall patient satisfaction.

Intra-ligamentary autologous conditioned plasma and healing response to treat partial ACL ruptures.

Conservative treatment of partial ACL ruptures is associated with a high failure rate, and often patients undergo ACL reconstruction. ACL preservation by trephination of the ACL origin and application of Autologous Conditioned Plasma (ACP) seems to be an intriguing new treatment option to favour ACL tissue healing and avoid traditional reconstruction. The aim of this study was to describe the mid-term outcomes of this new ACL preserving technique. Twenty-four patients (mean age 41.8years) affected by partial rupture of one or both ACL bundles were included in the present trial. The partial ACL tears were arthroscopically assessed and classified according to a new five step grading system. All patients were treated by trephination of the femoral ACL stump and intra-ligamentary application of ACP. The postoperative outcome was evaluated by both subjective scores and stability testing up to a mean of 25.1 months' follow-up. Adverse events and failure rate were also documented. Clinical outcome was good to excellent with IKDC subjective 82.7 (SD 11.8), Lysholm 87.6 (SD 8.1), Tegner 5.3 (SD 2.1), Cincinnati 88.7 (SD 14.8). The failure rate (i.e. persisting knee instability assessed clinically or by rolimeter) was 12.5%. At objective measurements, knee joints showed a firm endpoint in Lachman test, negative pivot shift phenomenon and a significant reduction in AP-laxity compared to pre-operative status by rolimeter testing (p = 0.002). Return to sport practice was achieved after mean 4.8 months (SD 4.1). ACL stump trephination and concomitant intra-ligamentary application of ACP revealed promising results at mid-term follow-up to treat partial ACL lesions.

Survival analysis of time-to-event data in orthopaedic surgery

With an increasing incidence of orthopaedic procedures performed worldwide, the quantity of data collected, including “Big Data”, is also rising. Widening indications for surgery, a growing number of implant options and variety of operative techniques, as well as an increasing need to demonstrate cost effectiveness, necessitate the use of robust analysis techniques to assess outcomes. Traditionally, analysis of outcomes in orthopaedic surgery involves survival methods, where the outcome of interest is ‘time to event’, which is usually revision or re-operation. For arthroplasty, this represents the time from the date of insertion of the implant until the date on which the revision is performed and patients whose outcomes are not known or have died are censored. Revision is generally taken as the primary indicator of failure of a joint replacement. Although revision/re-operation is dependent on many factors, including the fitness for surgery of the patient, it provides a firm endpoint for analysis, particularly in epidemiological studies. One of the strengths of survival analysis is the handling of incomplete data or follow-up. If an event is not seen within the timeframe observed or reported, there would be incomplete observations, known as censored events. ‘Right’ censoring is the most common and occurs either if a subject does not experience the event during the study period, is lost to follow-up or withdraws from the study. Death is another reason for censoring. The ‘risk set’ at a specific time point is defined as the individuals/implants that at that time are at risk of experiencing the event (e.g. revision). These are the individuals that have survived up to …

Impact of the Timing of Complete Remission and Transplantation on Estimates of Event-Free Survival in Acute Myeloid Leukemia

Background:Event free survival (EFS) is often used as an endpoint in AML clinical trials. EFS-based endpoints are controversial due to the lack of a consistent definition for the timing of complete remission (CR), and consideration of hematopoietic cell transplantation (HCT). Here, we examined the impact of the timing of achievement of CR and censoring for HCT in the estimation of the EFS, and assessed its robustness as an endpoint in AML.Methods:All prospective trials since 2003 using anthracycline and cytarabine chemotherapy for newly diagnosed patients (pts) with AML conducted through the Alliance for Clinical Trials in Oncology, and whose primary endpoint data has been reported, were included (5 trials total). Trial 1 - randomized phase III study in older AML pts (n=504, median age 69, 61% male); trial 2 - single-arm phase II study in older FLT3-mutated AML pts (n=54, median age 67, 56% male); trial 3 - randomized phase III study in younger AML pts (n=546, median age 48, 55% male); trial 4 - randomized phase III study in younger FLT3-mutated AML pts (n=717, median age 48, 45% male); and trial 5 - single arm phase II study in core-binding factor AML pts with no restriction on age (n=61, median age 51, 51% male). Induction failure was defined as one of: no CR by 60 days (Definition 1), no CR by the end of all protocol induction courses (Definition 2), or no CR by the end of all protocol treatment (Definition 3). CR was defined as <5% blasts in a cellular marrow with recovery of >1000 neutrophils/ul (>1500 neutrophils/ul for trial 1), >100,000 platelets/ul, and no red cell transfusion requirement. EFS was defined as the time from randomization / registration to the first evidence of induction failure using each of the 3 methods above, relapse, or death from any cause. Patients last known to be alive without relapse were censored at the date of last contact. Including the 3 induction failure definitions and consideration of censoring or no censoring for HCT, the Kaplan Meier estimates of EFS were computed for the six different definitions of EFS.Results:The number of deaths was respectively 464, 38, 307, 357, and 13 across the 5 trials, with a median follow-up of 99.7, 28.2, 60.1, 58.2, and 33.5 months on the alive patients, respectively. Not considering HCT, in trial 1, the median EFS ranged from 2.0 to 4.3 months (115% difference); in trial 2, the median EFS ranged from 6.9 to 8.3 months (20% difference); in trial 3, the median EFS ranged from 9.8 to11.2 months (14% difference); and in trial 4, the median EFS ranged from 5.5 to 9.7 months (76% difference). The median EFS was not achieved in trial 5; however the 1-year EFS estimates ranged from 78 to 83% (6% difference). Consistently across all trials, as expected, the EFS estimate using the 60-day induction failure yielded the shortest estimates, whereas the end-of-treatment induction failure yielded the longest estimates. Results were similar both with and without censoring at the time of HCT as the event of interest occurred prior to transplantation in most cases.Conclusions:Although relapse and death are firm endpoints, the determination of failure to achieve CR is not consistent across studies. While there is minimal impact of censoring at HCT on EFS estimates, the median EFS estimates differed considerably based on the timing of CR used to define induction failure, with the magnitude of difference being large enough in most cases (observed range: 14% to >100%) to lead to incorrect conclusions about efficacy in a single arm trial if the trial definition was not consistent with the definition used for the historical control. The timing of CR should be carefully examined in the historical control data used to guide the design of the next trial. [Display omitted] DisclosuresUy:Glycomimetics: Consultancy; Boehringer Ingelheim: Consultancy. Stone:Celator: Consultancy; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Agios: Consultancy; Amgen: Consultancy; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Consultancy; Novartis: Consultancy; Jansen: Consultancy; Pfizer: Consultancy; ONO: Consultancy; Juno Therapeutics: Consultancy; Merck: Consultancy; Roche: Consultancy; Seattle Genetics: Consultancy; Sunesis Pharmaceuticals: Consultancy; Xenetic Biosciences: Consultancy.

Knee Pain That Wasn’t in a Twin Cities Marathon Finisher

HISTORY: A 53 yo male marathon runner presented to the medical tent after finishing race complaining of R lat knee & ant distal thigh pain. His R knee “gave out” 30 m from finish line. He hopped on his L leg to finish the race (3 hr 45 min). He had completed several marathons without incident. He trained for 22 wk, but had 6 wk of self-diagnosed R “IT band pain” leading up to the race. He described his pain as starting in the hip & radiating down the thigh to his knee. He did not seek medical attention for this pain. He had no past hx of stress fx, disordered eating, or tobacco use. Takes Vit D & calcium daily & drinks milk regularly. PHYSICAL EXAM:Gait: Unable to bear weight. Inspection: (+) spasm of R quadriceps. No swelling, erythema, ecchymosis or atrophy. Palpation: Tender along groin, greater trochanter, & Gerdy’s tubercle. No effusion of knee or hip joint. Quad tendon-without noticeable defect. Knee non-tender. Active ROM: Unable to actively flex hip or elevate leg. SLR painful. Passive ROM & Strength: Hip & knee - limited by pain, able to fire quad against gravity & slide foot along bed in extension. Ligament Stability: Knee - Varus/valgus testing, ant & post drawer, & Lachman’s firm end points, R Lachman “looser” than L; inferior traction on R lower leg while in knee extension provided “instant pain relief” per patient.Leg Position: After pain relieved, R leg was externally rotated & shortened. DIFFERENTIAL DIAGNOSIS: Femur Fx (Femoral neck, head, or shaft) Quad tendon strain/rupture Patellar tendon rupture ITB rupture ACL sprain/rupture TESTS AND RESULTS: Imaging: Xray Femur: Comminuted fracture of femoral diaphysis with displacement & angulation. CT Scan Femur: Comminuted fx of femoral diaphysis centered proximal to middle-distal 1/3 junction with angulation & displacement. No underlying lytic lesion. R femoral neck synovial herniation pit described as normal variant, but also associated with femoral acetabular impingement. Labs: Testosterone: 726 ng/dl (nrl) Vit D: 38 ng/ml (nrl) FINAL/WORKING DIAGNOSIS: R Comminuted midshaft femur fracture atop a stress fx in marathon finisher TREATMENT AND OUTCOMES: ED transport by private vehicle Orthopedic surgeon determined surgery indicated Surgical procedure - locked intramedullary nail implanted Post Op: WBAT & ROM of hip & knee as tolerated DEXA scan scheduled

Efficacy of Arthroscopic suture fixation technique in comminuted avulsion fractures of Anterior Cruciate Ligament

Background: Treatment of comminuted avulsion fractures of Anterior Cruciate Ligament (ACL) is challenging. Arthroscopic fixation techniques such as fixation with Screws, staples, k-wires and Sutures are described to achieve this. But in comminuted avulsion fractures of ACL(Meyers and McKeever Type IV), attempts at internal fixation with screws, staples or k-wires often becomes impossible as small fragments of avulsed bone may further shatter while fixing them with implant. Hence we decided to perform arthroscopic reduction and fixation with sutures. Aim of this study is to demonstrate efficacy and benefits of fixation of ACL avulsion fractures with arthroscopic reduction and suture fixation technique. Methods: Patients diagnosed as having comminuted avulsion fractures of ACL and treated at our institute between November 2012 to January 2015 and those who were followed up in Out Patient Department or on telephone up to January 2016 were retrospectively studied. We could trace records of 23 patients who fulfilled our inclusion, exclusion and follow up criteria. Fixation of ACL avulsion fractures was performed with arthroscopic reduction and suture fixation technique. Results: 23 patients with comminuted avulsion fracture of Anterior Cruciate Ligament were studied retrospectively. Post-operatively 17 patients had full range of motion by 8 weeks. The remaining 6 patients had a range of 50 to 1100 at the 8 week. This was improved to 50 to 1250 till 12 weeks of follow up.19 patients had a negative Lachman test postoperatively, and 4 patients had a grade I Lachman, but with a firm end point. 2 patients had deep vein thrombosis on 3rd and 5th post-operative day. These patients were treated with low molecular weight heparin injections subcutaneously for 1 week followed by oral anticoagulants and physiotherapy. At an average of 27 months' follow-up (range, 12 to 39 months), all of the patients were satisfied with their outcome and returned to their pre-injury function

Micheli Anterior Cruciate Ligament Reconstruction in Skeletally Immature Youths

Background: The management of anterior cruciate ligament (ACL) tears in the skeletally immature patient remains controversial. Outcomes on a physeal-sparing technique using the iliotibial band for combined intra-articular and extra-articular ACL reconstruction, called the Micheli technique, have been described and reported by the original authors. Purpose: To evaluate the clinical outcomes of a physeal-sparing technique using the iliotibial band for combined intra-articular and extra-articular ACL reconstruction. Study Design: Case series; Level of evidence, 4. Methods: Between 2005 and 2011, all patients who underwent Micheli ACL reconstruction performed by a single surgeon were identified. A minimum of 3 years’ growth remaining was a prerequisite for Micheli reconstruction. Patients were excluded if postoperative follow-up was less than 1 year. Patients were evaluated for functional outcomes, satisfaction, graft survival, radiographic and clinical evidence of growth disturbance, and the need for additional procedures. Results: Twenty-one patients (22 knees) met the inclusion criteria for this study. The mean age at the time of surgery was 11.8 years (range, 9.9-14.0 years). All patients were male. There were 4 concomitant meniscal repairs and 5 partial meniscectomies performed. All patients (100%) completed follow-up at a mean duration of 3.0 years (range, 1.0-6.9 years). Overall, 6 knees (27%) underwent reoperation. Of these, 3 knees (14%) underwent revision ACL surgery: 2 revision reconstructions at 2.8 and 4.0 years postoperatively and 1 graft shrinkage at 4.7 months postoperatively. Three knees (14%) underwent subsequent meniscal procedures, including 2 partial meniscectomies and 1 meniscal repair. Of the 19 knees that did not require revision ACL surgery, the median patient satisfaction score was 10 (range, 9-10). The mean Pediatric International Knee Documentation Committee score was 96.5 ± 2.9, and the mean Lysholm score was 95.0 ± 6.1. The median preinjury Tegner activity level was 8 (range, 6-10), and the median postoperative Tegner activity level was 8 (range, 6-10). Of the 19 knees that did not require revision ACL surgery, all had a normal Lachman test result, with a firm endpoint and normal pivot shift. At follow-up, 53% of knees had closed physes. There were no angular deformities or limb-length discrepancies. Conclusion: At a mean 3-year follow-up, the study findings confirmed excellent functional outcomes, a low ACL revision rate, and no growth disturbances. Patients returned to their preoperative activity level after reconstruction. This procedure offers a safe and effective ACL reconstruction option in children with several years of growth remaining.

The double-pulley technique for anatomical double-bundled medial patellofemoral ligament reconstruction

IntroductionMajority of the current medial patellofemoral ligament (MPFL) reconstruction techniques vary with respect to methods of fixation on the patella. In an effort to maximise the area of patellar footprint coverage and minimise the complication of patellar fracture, we developed a procedure that implemented the double-pulley suture anchors technique. DesignProspective case series. SettingA primary medical centre in Kaohsiung, Taiwan. Patients and methodsEighteen consecutive patients (18 knees) who met the inclusion criteria underwent the aforementioned operation between January 2010 and March 2012. Patients were evaluated using functional scores (Kujala and Tegner–Lysholm scores), apprehension test, and radiographic examination (congruence angle and patellar tilting angle) preoperatively and at the follow-up. ResultsThe mean follow-up was 35 months. A firm endpoint to lateral patellar translation was noted in all patients at the last follow-up with a mean lateral translation quadrant of 1.5 (improved from 3.5 preoperatively, p<0.001). Both clinical and radiographic assessment improved significantly (p<0.001); the mean Kujala score improved from 55.3±6.8 preoperatively to 95.2±3.5 at the last follow-up; TegnerLysholm from 43.6±8.1 to 93.6±6.8; the mean congruence angle improved from 20.6°±2.1° preoperatively to −5.2°±2.4° at the last follow-up; and the patellar tilting angle from 23.8°±2.3° to 9.6°±1.3°. ConclusionThe double-pulley patellar fixation technique, by having a result that is comparable with those of other studies that used aperture fixation techniques, can be a promising surgical option for anatomically reconstructing the medial petellofemoral ligament.