Capsulotomy in Unstable Slipped Capital Femoral Epiphysis and the Odds of AVN: A Meta-analysis of Retrospective Studies.

BACKGROUND: Unstable slipped capital femoral epiphysis (SCFE) may lead to avascular necrosis (AVN) in up to 60% of patients. The aim of this study was to assess the best clinical evidence to determine the effect of capsular decompression (CD) on odds of AVN in unstable SCFE. METHODS: Medline, Embase, and Cochrane databases were systematically searched for comparative studies investigating AVN rates in unstable SCFE treated with or without CD (aspiration, percutaneous, or open). Quality was evaluated by the Newcastle Ottawa Scale. A comparative analysis with pooled effect estimates using random-effects modeling was calculated. Secondary analysis pooled AVN rates from both comparative studies and case series. RESULTS: Comparative analysis included 17 retrospective studies with 453 hips (201 with CD, 252 without CD). Thirty-four of 201 (17%) hips with CD developed AVN, while 67 of 252 (27%) hips without CD developed AVN. The odds of AVN for patients treated with or without CD [odds ratio=0.80, 95% confidence interval (CI): 0.48-1.35] was not statistically different. Subanalysis on patients treated with in situ pinning or positional reduction and pinning showed no difference in AVN rates with or without CD (odds ratio=0.97, 95% CI: 0.44-2.10). In the secondary analysis of 17 comparative studies and 23 case series, the average rate of AVN was 17%, 0.17 (95% CI: 0.13-0.23) for patients treated with CD (60/447 hips) and 28%, 0.28 (95% CI: 0.22-0.35) for patients treated without CD (129/464 hips). CONCLUSIONS: There was no statistically significant decrease in odds of AVN with CD. However, studies were limited by their retrospective nature and inadequate documentation of CD techniques; the majority lacked femoral head blood flow monitoring to demonstrate adequate decompression. Future prospective studies with carefully documented complete decompression may help to elucidate the effect of CD on AVN risk. Although there was no statistically different odds of AVN with or without CD, even this large meta-analysis was underpowered, and one cannot conclude that there was truly no difference in odds of AVN without an appropriately powered study. Therefore, we recommend routine CD for all unstable SCFEs pending additional research, as CD adds little to the surgical procedure and may minimize the risk of a devastating insult to the femoral head.

Utilization of a Wide Array of Nonvalidated Outcome Scales in Pediatric Orthopaedic Publications: Can't We All Measure the Same Thing?

PURPOSE: Clinical changes are best evaluated with standardized, validated outcomes, including both patient-reported outcome measures and surgeon-reported outcome measures (PROMs and SROMs). The purpose of this study was to describe the spectrum of outcome measures used in pediatric orthopaedic publications over the past 10 years and to determine the proportion that are in fact age-appropriate, validated, and appropriately applied in terms of condition and population. METHODS: The Journal of Bone and Joint Surgery, The Bone and Joint Journal, Journal of Pediatric Orthopaedics A and B, and Journal of Children's Orthopaedics were systematically searched for studies including children aged 18 and below, over a 10-year period from January 2005 to December 2014. Economic evaluations, letters, editorials, review articles, and clinical guidelines were excluded. SROMs and PROMs used were extracted, as were details on subject age and condition for which they were used. Each outcome scale was assessed for validity, and the proportion of scales used appropriately was calculated. Cochrane-Armitage test of trend was used to determine changes in PROM and SROM utilization over the study period. RESULTS: A total of 4614 articles were identified, of which 2251 met inclusion and exclusion criteria. In total, 259 (11.5%) of studies used a PROM, whereas 326 (14.5%) used a SROM. A total of 230 different outcome scales were identified; 115 were patient reported and 115 were surgeon reported. However, only 18.7% of SROMs and 38.3% of PROMs were applied to an age and disease-appropriate demographic. Overall, there was a significant increase in the overall utilization of PROMs during the study period (P=0.004), but no corresponding increase in pediatric-validated PROMs (P=0.164). SROM utilization did not significantly change over the study period (P=0.337). CONCLUSIONS: Within the field of pediatric orthopaedics, an expansive variety of outcome scales are used, many of which have not been validated in children. Improved uniformity in reporting of outcomes and use of disease and age-validated outcomes scales is essential to improve multicenter research collaboration and data quality to generate appropriate evidence-based conclusions and treatment strategies in pediatric orthopaedics. LEVEL OF EVIDENCE: Level IV-systematic review.

The Fragility of Statistically Significant Results in Pediatric Orthopaedic Randomized Controlled Trials as Quantified by the Fragility Index: A Systematic Review.

BACKGROUND: The randomized controlled trial (RCT) is the gold standard study design allowing critical comparison of clinical outcomes while minimizing bias. Traditionally clinical trials are evaluated through statistical significance, expressed by P-values and confidence intervals. However, until recently, the robustness of a study's conclusions has been given little attention. A new metric, the fragility index, quantifies the number of patients theoretically required to switch outcomes in order to reverse the study conclusions. The primary aim of our work was to determine the fragility index of RCTs in the pediatric orthopaedic literature. The secondary aim was to determine study factors associated with lower fragility index. METHODS: Pubmed and Embase were systematically searched for pediatric orthopaedic RCTs published September 1, 2006 to September 1, 2016. Two independent reviewers screened titles, abstracts, and manuscripts to identify studies published in English involving 2 treatment arms. Trials without dichotomous primary or secondary outcomes or with patients >18 years were excluded. Data were extracted from each eligible article in duplicate and the fragility index was determined using Fisher exact test, with previously published methods. Univariate analysis was used to determine factors associated with lower fragility index. RESULTS: Seventeen trials were eligible for inclusion. The median treatment arm size was 58 and overall sample size was 116 patients. The median fragility index was 3 (range, 0 to 18). A fragility index of 3 means that just 3 patients would need to switch treatment outcomes in order for the trial results to become statistically nonsignificant. In 1 study, the number of patients lost to follow-up exceeded the fragility index, such that the study conclusions could be completely reversed purely depending on the outcomes of the patients lost to follow-up. Lower fragility index was associated with smaller patient sample sizes and greater P-values. CONCLUSIONS: The fragility index is a useful adjunct metric to the P-value and confidence intervals, allowing analysis of the robustness of study conclusions. RCTs in pediatric orthopaedics often have small sample sizes, many with low fragility indices. Future efforts could focus on encouraging institutional collaboration and patient recruitment with the ultimate goal of improving RCT sample sizes, and potentially improving the robustness of RCT results. LEVEL OF EVIDENCE: Level I.