Patients Undergoing Primary Hip Arthroscopy Report Favorable Outcomes at Minimum 10 Year Follow-Up: A Systematic Review.

PURPOSE: (1) To evaluate minimum 10-year PROs (patient-reported outcomes) and survivorship after primary hip arthroscopy and (2) to identify predictors of failure for secondary arthroscopy and conversion to total hip arthroplasty (THA). METHODS: A systematic review of the literature was conducted with the following key words: "hip arthroscopy," "long-term," "outcomes," "ten-year," "survivorship," "10-year," "15-year," "fifteen-year," 20-year," "twenty-year," and "femoroacetabular impingement" in PubMed and Embase in March 2022 using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Level I to Level IV evidence was included and reported on minimum 10-year outcomes or greater after primary hip arthroscopy. Long-term studies were defined as minimum 10-year follow-up in accordance with established standards in the literature. Case reports, review articles, technique articles, and opinion articles were excluded. Articles not in English were excluded. Title, author, publication date, study design, demographic, number of hips, follow-up time, study period, indications for hip arthroscopy, PROs, predictors of failure for THA, and rates of secondary surgeries were recorded. Survivorship was defined as a nonconversion to THA. P < .05 was defined as statistical significance. RESULTS: Twelve studies met the inclusion criteria. In total, 4 studies were Level III, and 8 studies were Level IV. A total of 1,344 hips were included, and follow-up ranged from 10 to 20 years. Femoroacetabular impingement syndrome was the most common indication for hip arthroscopy. Ten of the 12 studies reported on PROs, and 8 studies reported significant improvement after hip arthroscopy at long-term follow-up. The remaining 2 studies reported favorable outcomes that satisfied clinical benefit thresholds at minimum 10-year follow-up. Five studies reported clinical benefit where each patient cohort achieved 80% minimal clinically important difference and 75% patient acceptable symptomatic state for at least one PRO. Rates of secondary arthroscopy ranged from 4.5% to 24%, and rates of conversion to THA varied from 0% to 44.1%. Older age and chondral damage were the most commonly cited predictors for conversion to THA. CONCLUSIONS: At long-term follow-up, patients who underwent primary hip arthroscopy demonstrated favorable outcomes and variable rates of secondary surgeries. Patients undergoing hip arthroscopy within the last 20 years with Tönnis grade <1 and labral repair experienced greater than 90% survivorship. Chondral damage and older age were the most cited predictors for conversion to THA. LEVEL OF EVIDENCE: Level IV, systematic review of Level III and Level IV studies.

Analysis of the Frequency, Characteristics, and Reasons for Termination of Spine-related Clinical Trials.

STUDY DESIGN: Cross-sectional analysis of completed and terminated spine-related clinical trials in the ClinicalTrials.gov registry. OBJECTIVE: The aim was to quantify completed and terminated spine-related clinical trials, assess reasons for termination, and determine predictors of termination by comparing characteristics of completed and terminated trials. SUMMARY OF BACKGROUND DATA: Clinical trials are key to the advancement of products and procedures related to the spine. Unfortunately, trials may be terminated before completion. ClinicalTrials.gov is a registry and results database maintained by the National Library of Medicine that catalogs trial characteristics and tracks overall recruitment status (eg, ongoing, completed, terminated) for each study as well as reasons for termination. Reasons for trial termination have not been specifically evaluated for spine-related clinical trials. METHODS: The ClinicalTrials.gov database was queried on July 20, 2021 for all completed and terminated interventional studies registered to date using all available spine-related search terms. Trial characteristics and reason for termination, were abstracted. Univariate and multivariate analyses were performed determine predictors of trial termination. RESULTS: A total of 969 clinical trials were identified and characterized (833 completed, 136 terminated). Insufficient rate of participant accrual was the most frequently reported reason for trial termination, accounting for 33.8% of terminated trials.Multivariate analysis demonstrated increased odds of trial termination for industry-sponsorship [odds ratio (OR)=1.59] relative to sponsorship from local groups, device studies (OR=2.18) relative to investigations of drug or biological product(s), and phase II (OR=3.07) relative to phase III studies ( P <0.05 for each). CONCLUSIONS: Spine-related clinical trials were found to be terminated 14% of the time, with insufficient accrual being the most common reason for termination. With significant resources put into clinical studies and the need to advance scientific objectives, predictors, and reasons for trial termination should be considered and optimized to increase the completion rate of trials that are initiated.