From Protocol to Definitive Study-The State of Randomized Controlled Trial Evidence in Sports Medicine Research: A Systematic Review and Survey Study.

OBJECTIVE: To evaluate the progression, quality, and challenges associated with conducting and publishing randomized controlled trials (RCTs) in sports medicine. DESIGN: Systematic review and survey. SETTING: MEDLINE and Embase were searched for all publications before September 17, 2021. A targeted search of clinicaltrials.gov , BMC Musculoskeletal Disorders, PubMed, and Google Scholar were also conducted. The survey was administered to authors using REDCap. PARTICIPANTS: Where the systematic search revealed no corresponding published definitive trial, authors of the published pilots were surveyed. INTERVENTIONS: Survey assessing limitations to definitive trials. MAIN OUTCOME MEASURES: Protocol/method articles, pilot articles, and relevant clinical trial registry records with corresponding definitive trials were pooled. RESULTS: Our literature search yielded 27 006 studies; of which, we included 208 studies (60 (28.8%) pilot RCTs, 84 (40.4%) protocol/method articles, and 64 (30.8%) trial registry records). From these, 44 corresponding definitive RCTs were identified. Pilot study and definitive RCT methodological quality increased on average most significantly during the duration of this review (30.6% and 8.2%). Of the 176 authors surveyed, 59 (33.5%) responded; 24.6% (14/57) stated that they completed an unpublished definitive trial, while 52.6% (30/57) reported having one underway. CONCLUSIONS: The quality and number of RCT publications within the field of sports medicine has been increasing since 1999. The number of sports medicine-related protocol and pilot articles preceding a definitive trial publication showed a sharp increase over the past 10 years, although only 5 pilot studies have progressed to a definitive RCT.

Revision Arthroscopic Bankart Repair for Anterior Shoulder Instability After a Failed Arthroscopic Soft-Tissue Repair Yields Comparable Failure Rates to Primary Bankart Repair: A Systematic Review.

BACKGROUND: The management of recurrent instability after arthroscopic Bankart repair remains challenging. Of the various treatment options, arthroscopic revision repairs are of increasing interest due to improved visualization of pathology and advancements in arthroscopic techniques and instrumentation. PURPOSE: We sought to assess the indications, techniques, outcomes, and complications for patients undergoing revision arthroscopic Bankart repair after a failed index arthroscopic soft-tissue stabilization for anterior shoulder instability. METHODS: We performed a systematic review of studies identified by a search of Medline, Embase, and PubMed. Our search range was from data inception to April 29, 2020. Outcomes include clinical outcomes and rates of complication and revision. The Methodological Index for Non-randomized Studies (MINORS) was used to assess study quality. Data are presented descriptively. RESULTS: Twelve studies were identified, comprising 279 patients (281 shoulders) with a mean age of 26.1 ± 3.8 years and a mean follow-up of 55.7 ± 24.3 months. Patients had improvements in postoperative outcomes (eg, pain and function). The overall complication rate was 29.5%, the most common being recurrent instability (19.9%). CONCLUSION: With significant improvements postoperatively and comparable recurrent instability rates, there exists a potential role in the use of revision arthroscopic Bankart repair where the glenoid bone loss is less than 20%. Clinicians should consider patient history and imaging findings to determine whether a more rigorous stabilization procedure is warranted. Large prospective cohorts with long-term follow-up and improved documentation are required to determine more accurate failure rates.

All-epiphyseal anterior cruciate ligament reconstruction produces good functional outcomes and low complication rates in pediatric patients: a systematic review.

PURPOSE: To assess the literature on indications, outcomes, and complications in pediatric patients undergoing all-epiphyseal (AE) anterior cruciate ligament reconstruction (ACLR). METHODS: PubMed, Medline, and Embase were searched for literature evaluating AE ACLR in pediatric patients. All included studies were assessed for quality using the Methodological Index for Non-Randomized Studies (MINORS). Descriptive statistics are presented where applicable. RESULTS: Overall, 17 studies comprising 545 patients, with a mean age of 12.0 ± 1.2 (range 8-19) met the inclusion criteria. The graft choices in this systematic review included hamstring tendon autografts (75.4%, n = 403), quadriceps tendon autograft (6.2%, n = 33), Achilles tendon allograft (3.6%, n = 19) and posterior tibialis tendon allograft in one patient (0.2%, n = 1). Time of return-to-sport ranged from 8 to 22 months. Postoperative subjective IKDC scores were above 90 points. The rate of return-to-sport after AE ACLR was 93.2% (n = 219/235) and 77.9% (n = 142/183) of patients returned to sport at pre-injury level. The overall complication rate was 9.8% (n = 53/545) with the most common complication being ACL re-rupture (5.0%; n = 27/545). Only 1.5% (n = 8/545) of patients demonstrated growth disturbances. CONCLUSION: Overall, the AE ACLR technique can achieve good postoperative functional outcomes while notably minimizing the incidence of primary issue of physeal disruption and potential associated leg-length discrepancies. AE ACLR should be considered in pediatric patients with at least 2 years of skeletal growth remaining based on radiographic bone age to minimize the impact of growth-related complications. LEVEL OF EVIDENCE: IV (Systematic Review of Level III and IV evidence).

Historical analysis of the diagnosis and management of femoroacetabular impingement prior to the year 2000: a systematic review.

This systematic review aims to assess the diagnosis, indications and treatment of femoroacetabular impingement (FAI) prior to the year 2000 and to determine if historical concepts remain applicable today. PUBMED, MEDLINE and EMBASE were searched for literature evaluating the diagnosis/treatment of FAI prior to 2000. Cadaver/non-human, non-English and review studies were excluded. Quality assessment was performed using the Methodological Index for Non-Randomized Studies. Nine studies comprising 307 patients [315 hips; mean age of 32.6 ± 2.4 years (range, 12-58)] were included. Patients reported groin pain. Magnetic resonance arthrography (MRA; n = 76) and the anterior impingement test (AIT) (n = 88) were used to diagnose impingement. Surgical dislocation with a trochanteric flip osteotomy (n = 237) and Bernese periacetabular osteotomy (n = 40) were common treatments. Pain and range of motion improved for patients. Overall complication rate was 35% (n = 99), with heterotopic ossification (n = 79) most commonly reported. Prior to 2000, there was low quantity and quality of research on the diagnosis/management of FAI. Diagnostic evaluation was primarily through clinical examination (i.e. groin pain and AIT). MRA was occasionally used to detect labral degeneration; however, utilization of computed tomography (CT) and diagnostic injections were not reported. Surgical dislocation and osteotomies of the acetabulum yielded desirable short-term clinical outcomes with a moderate complication rate. No study reported using arthroscopy for FAI management prior to 2000. Clinicians today can learn from historical principles (i.e. clinical diagnosis of FAI, management with surgical correction of femoral head-neck offset) while applying novel techniques (i.e. CT, injections, arthroscopic surgical techniques and rehabilitation) to improve patient outcomes. LEVEL OF EVIDENCE: IV (systematic review of III and IV evidence).

Outcomes and complications of patients undergoing Salter's innominate osteotomies for hip dysplasia: a systematic review of comparative studies.

The purpose of this systematic review is to assess outcomes and complications of patients undergoing Salter's innominate osteotomies (SIOs) for the correction of hip dysplasia along with patient and technical factors that can be optimized to improve outcomes after SIO. MEDLINE and EMBASE were searched from data inception to 9 October 2018. Data were presented descriptively. Twenty-seven studies were identified including 1818 hips (87.1%) treated with SIO (mean age of 2.1 ± 2.5 years and mean follow-up of 3.5 ± 5.0 years). Patients undergoing SIO had a post-operative center-edge angle (CEA) of 31.3° ± 5.3° and an acetabular index (AI) angle of 16.1° ± 5.2°. Patients undergoing SIO with pre-operative traction had significantly lower (P = 0.049) post-operative McKay criteria scores compared to patients without pre-operative traction. Patients undergoing SIO between the ages of 1.5-2 years had significantly better (P < 0.05) post-operative McKay criteria scores compared to patients aged 4-6 years. The complication rate was 9.4% with avascular necrosis (2.5%) being most common. This review found that SIO for developmental dysplasia of the hip produces generally good post-operative clinical outcomes. The CEA and AI can be corrected to normal range after SIO. Patients may have superior outcomes if they have SIO at a younger age, were not treated with pre-operative traction and did not have untreated contralateral hip dysplasia. Outcomes appear to be similar between one-stage bilateral SIO and a two-stage procedure in the setting of bilateral hip dysplasia; however, more multicentered studies are needed to confirm these results.

The repair of horizontal cleavage tears yields higher complication rates compared to meniscectomy: a systematic review.

PURPOSE: Horizontal cleavage tears of the meniscus (HCTs) are primarily degenerative in nature, and, however, can be the result of trauma. Such tears account for 12-35% of all tear patterns and can be treated by partial meniscectomy or arthroscopic repair. The purpose of this review was to systematically assess the outcomes and complications for patients undergoing the surgical treatment of HCTs. METHODS: This review has been conducted according to the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-analyses. The electronic databases PubMed, MEDLINE, and EMBASE were searched from data inception to December 30, 2018 for articles addressing the surgical treatment of HCTs. The Methodological Index for Non-randomized Studies was used to assess study quality. Data are presented descriptively. RESULTS: Overall, 23 studies were identified, comprising of 702 patients (708 knees) with a mean age of 36.6 ± 9.9 years and a mean follow-up of 33.6 ± 19.6 months. The majority of patients were treated with a partial meniscectomy (59.0%), followed by repair (32.8%) and total meniscectomy (8.2%). Both meniscectomy and repair patients had improvements which surpassed minimal clinically important differences with regard to clinical (e.g. pain, function, daily living) and radiographic outcomes. The overall complication rate was 5.1%, primarily involving patients undergoing meniscal repair (12.9% of all knees undergoing a repair). CONCLUSION: Although meniscal repair theoretically may provide improvement in biomechanical loading, patients undergoing repair had higher complication rates than those undergoing partial meniscectomy. Clinicians should consider the available implants in determining which tear patterns to repair and future studies with long-term follow-up are needed to investigate complications (e.g. secondary meniscal procedures) as well as the potential for delay in the development of osteoarthritis. LEVEL OF EVIDENCE: Level IV.

Anteromedial Portal Double-Bundle Anterior Cruciate Ligament Reconstruction Yields Similar Outcomes to Non-AMP Femoral Drilling Double-Bundle Techniques: A Systematic Review of Comparative Studies.

BACKGROUND: Biomechanical studies have shown double-bundle (DB) anterior cruciate ligament reconstruction (ACLR) to have increased anterior and rotational stability as compared with single-bundle ACLR. Various techniques exist to drill the femoral tunnel, such as anteromedial portal (AMP), outside-in (OI), and transtibial (TT) drilling. However, it is unclear whether one drilling technique is superior to others when a DB graft is used. PURPOSE: To systematically assess the outcomes and complications in patients undergoing DB ACLR through an AMP technique as compared with other femoral drilling techniques. STUDY DESIGN: Systematic review; Level of evidence, 3. METHODS: PubMed, Medline, and EMBASE databases were searched in April 2018. Nonrandomized studies were assessed with the MINORS (Methodological Index for Nonrandomized Studies), whereas randomized studies were assessed with the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. RESULTS: Ten studies comprising 722 patients satisfied the inclusion criteria. A total of 351 patients underwent DB ACLR with AMP drilling (mean ± SD age, 32.7 ± 4.7 years); 318 patients had DB ACLR with OI drilling (age, 31.9 ± 4.1 years); and 53 received a DB ACLR with TT drilling (age, 26.5 ± 2.0 years). Graft types used included hamstring autograft (74.1%; n = 247), tibialis anterior autograft (6.0%; n = 20) and unspecified grafts (19.8%; n = 66). No significant difference in postoperative Tegner and Lysholm scores was found between the AMP and OI groups postoperatively. The AMP group had a lower anterior and posterior graft bending angle as compared with the OI group. Four patients (1.1%) in the AMP group had graft reruptures, as compared with 9 reruptures (2.8%) in the OI group. There were no reports of rerupture in the TT group. CONCLUSION: DB AMP ACLR results in significantly improved functional outcome scores postoperatively. AMP techniques yield similar functional outcomes to OI ACLR. No direct comparison in functional outcomes scores were available between the AMP and TT techniques. Low overall complication and revision rates were observed for patients undergoing DB AMP ACLR and were found to be similar to those of other femoral drilling techniques. Owing to a steeper graft bending angle in patients undergoing OI or TT ACLR relative to AMP ACLR, patients treated with OI or TT femoral drilling may have increased strain placed on the graft. Based on the various limitations in the available literature, it is not currently possible to make a definite conclusion of whether AMP is superior to non-AMP techniques in the setting of DB ACLR.

Surgical Techniques, Outcomes, Indications, and Complications of Simultaneous High Tibial Osteotomy and Anterior Cruciate Ligament Revision Surgery: A Systematic Review.

BACKGROUND: The incidence of primary anterior cruciate ligament reconstruction (ACLR) failure ranges from 10 to 20% in the USA. Many patient and surgical factors may lead to re-rupture after ACLR. Some authors have suggested that not correcting excessive posterior tibial slope may be a significant contributing factor to ACLR failure. PURPOSES: We sought to systematically review the literature on outcomes, indications, and complications in patients undergoing simultaneous high tibial osteotomy (HTO) and ACLR revision. METHODS: PubMed, Medline, and Embase were searched in February 2018 for articles addressing simultaneous HTO and ACLR revision in skeletally mature patients. Major orthopedic conferences were screened in duplicate to find gray literature. All studies were assessed using the Methodological Index for Non-Randomized Studies. Descriptive statistics are presented where applicable. RESULTS: Seven studies satisfied inclusion. Seventy-seven patients underwent combined HTO and ACLR revision. The main indications were a posterior slope of more than 12° or severe varus malalignment. Graft types included hamstring tendon autograft (58.4%; n = 45) and quadriceps tendon graft (16.9%; n = 13). Mean delay between primary and revision surgery was 9 years. Rehabilitation protocol dictated return to running at 4 months and return to sport at 4 to 9 months. Visual analog scale pain scores reduced on average by 30 points. Subjective International Knee Documentation Committee, Tegner-Lysholm, and Tegner activity scores also improved. Fifty-eight percent (35/60) of patients showed osteoarthritis signs post-operatively. One patient (1.3%) received an arthroscopic arthrolysis of adhesions for stiffness. There were no reported incidences of graft re-rupture. CONCLUSION: This systematic review found that the use of HTO for ACLR revision produces good post-operative functional outcomes, low complication rates, and no reported re-ruptures. The main indications for combined HTO with ACLR revision was a posterior slope of more than 12° or severe varus malalignment. Future studies with large sample sizes and long-term follow-up are required to corroborate these results.