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The Fragility Index of Hip Arthroscopy Randomized Controlled Trials: A Systematic Survey

Published:February 01, 2021DOI:https://doi.org/10.1016/j.arthro.2021.01.049

      Purpose

      To characterize the fragility index (FI) of statistically significant results from randomized controlled trials (RCTs) in hip arthroscopy.

      Methods

      The PubMed-MEDLINE, Embase, and Cochrane databases were queried for hip arthroscopy RCTs published between January 2010 and July 2020. RCTs were included if they contained only 2 treatment arms, randomized patients to a 1:1 allocation to each arm, and reported at least 1 statistically significant dichotomous outcome. The fragility quotient was calculated for each RCT by dividing the FI by the sample size. Smaller FIs indicated more fragile results. Risk of bias was assessed using the Cochrane risk-of-bias tool for randomized trials.

      Results

      We identified 8 hip arthroscopy RCTs that met all inclusion and exclusion criteria. Most of the studies were assessed to have an overall low risk of bias. In the 2 studies with a moderate risk of bias and 1 study with a high risk of bias, concerns were raised about high rates of crossover and loss to follow-up. The median FI was 4, with FIs ranging from 0 to 14, but half of the studies had an FI of 2 or less. In 4 of the 8 studies, the number of patients lost to follow-up was greater than the FI.

      Conclusions

      A systematic survey of hip arthroscopy RCTs resulted in a low FI, indicating that the findings tended to be fragile. A low FI was consistent with findings reported in other orthopaedic and medical literature. Given these results, there is a possibility for findings to be altered by factors such as loss to follow-up, measurement subjectivity, crossover, and biased study design. Results on the fragility of hip arthroscopy RCTs were similar to those reported in general or orthopaedic-specific literature.

      Level of Evidence

      Level II, systematic review of Level I and II studies.
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      References

        • Konyves A.
        Editorial Commentary: The demise of randomized controlled trials in hip arthroscopy?.
        Arthroscopy. 2016; 32: 25
        • Calster B.V.
        • Steyerberg E.W.
        • Collins G.S.
        • Smits T.
        Consequences of relying on statistical significance: Some illustrations.
        Eur J Clin Invest. 2018; 48e12912
        • Katz J.N.
        • Losina E.
        Uses and misuses of the P value in reporting results of orthopaedic research studies.
        J Bone Joint Surg Am. 2017; 99: 1507-1508
        • Walsh M.
        • Srinathan S.K.
        • McAuley D.F.
        • et al.
        The statistical significance of randomized controlled trial results is frequently fragile: A case for a fragility index.
        J Clin Epidemiol. 2014; 67: 622-628
        • Ruzbarsky J.J.
        • Khormaee S.
        • Daluiski A.
        The fragility index in hand surgery randomized controlled trials.
        J Hand Surg. 2019; 44 (698.e1-698.e7)
        • Evaniew N.
        • Files C.
        • Smith C.
        • et al.
        The fragility of statistically significant findings from randomized trials in spine surgery: A systematic survey.
        Spine J. 2015; 15: 2188-2197
        • Ruzbarsky J.J.
        • Rauck R.C.
        • Manzi J.
        • Khormaee S.
        • Jivanelli B.
        • Warren R.F.
        The fragility of findings of randomized controlled trials in shoulder and elbow surgery.
        J Shoulder Elbow Surg. 2019; 28: 2409-2417
        • Khormaee S.
        • Choe J.
        • Ruzbarsky J.J.
        • et al.
        The fragility of statistically significant results in pediatric orthopaedic randomized controlled trials as quantified by the fragility index: A systematic review.
        J Pediatr Orthop. 2018; 38: e418-e423
        • Khan M.
        • Evaniew N.
        • Gichuru M.
        • et al.
        The fragility of statistically significant findings from randomized trials in sports surgery: A systematic survey.
        Am J Sports Med. 2017; 45: 2164-2170
        • Reito A.
        • Raittio L.
        • Helminen O.
        Fragility index, power, strength and robustness of findings in sports medicine and arthroscopic surgery: A secondary analysis of data from a study on use of the Fragility Index in sports surgery.
        PeerJ. 2019; 7e6813
        • Spindler K.P.
        • Kuhn J.E.
        • Dunn W.
        • Matthews C.E.
        • Harrell Jr., F.E.
        • Dittus R.S.
        Reading and reviewing the orthopaedic literature: A systematic, evidence-based medicine approach.
        J Am Acad Orthop Surg. 2005; 13: 220-229
        • Sterne J.A.C.
        • Savović J.
        • Page M.J.
        • et al.
        RoB 2: A revised tool for assessing risk of bias in randomised trials.
        BMJ. 2019; 366: l4898
        • Guyatt G.H.
        • Oxman A.D.
        • Kunz R.
        • et al.
        GRADE guidelines: 2. Framing the question and deciding on important outcomes.
        J Clin Epidemiol. 2011; 64: 395-400
        • ClinCalc
        Fragility index calculator.
        • Tignanelli C.J.
        • Napolitano L.M.
        The fragility index in randomized clinical trials as a means of optimizing patient care.
        JAMA Surg. 2019; 154: 74-79
        • Ahmed W.
        • Fowler R.A.
        • McCredie V.A.
        Does sample size matter when interpreting the fragility index?.
        Crit Care Med. 2016; 44: e1142
        • Krych A.J.
        • Thompson M.
        • Knutson Z.
        • Scoon J.
        • Coleman S.H.
        Arthroscopic labral repair versus selective labral debridement in female patients with femoroacetabular impingement: A prospective randomized study.
        Arthroscopy. 2013; 29: 46-53
        • Purcell R.L.
        • Brooks D.I.
        • Steelman T.J.
        • et al.
        Fascia iliaca blockade with the addition of liposomal bupivacaine versus plain bupivacaine for perioperative pain management during hip arthroscopy: A double-blinded prospective randomized control trial.
        Arthroscopy. 2019; 35: 2608-2616
        • Palmer A.J.R.
        • Gupta V.A.
        • Fernquest S.
        • et al.
        Arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of symptomatic femoroacetabular impingement: Multicentre randomised controlled trial.
        BMJ. 2019; 364: l185
        • Beckmann J.T.
        • Wylie J.D.
        • Potter M.Q.
        • Maak T.G.
        • Greene T.H.
        • Aoki S.K.
        Effect of naproxen prophylaxis on heterotopic ossification following hip arthroscopy: A double-blind randomized placebo-controlled trial.
        J Bone Joint Surg Am. 2015; 97: 2032-2037
        • Ward J.P.
        • Albert D.B.
        • Altman R.
        • Goldstein R.Y.
        • Cuff G.
        • Youm T.
        Are femoral nerve blocks effective for early postoperative pain management after hip arthroscopy?.
        Arthroscopy. 2012; 28: 1064-1069
        • Rafols C.
        • Monckeberg J.E.J.E.
        • Numair J.
        • Botello J.
        • Rosales J.
        Platelet-rich plasma augmentation of arthroscopic hip surgery for femoroacetabular impingement: A prospective study with 24-month follow-up.
        Arthroscopy. 2015; 31: 1886-1892
        • Xing J.G.
        • Abdallah F.W.
        • Brull R.
        • et al.
        Preoperative femoral nerve block for hip arthroscopy: A randomized, triple-masked controlled trial.
        Am J Sports Med. 2015; 43: 2680-2687
        • Yuan L.
        • Zhang Y.
        • Xu C.
        • Wu A.
        Postoperative analgesia and opioid use following hip arthroscopy with ultrasound-guided quadratus lumborum block: A randomized controlled double-blind trial.
        J Int Med Res. 2020; 48 (300060520920996)
        • Bertaggia L.
        • Baiardo Redaelli M.
        • Lembo R.
        • et al.
        The fragility index in peri-operative randomised trials that reported significant mortality effects in adults.
        Anaesthesia. 2019; 74: 1057-1060
        • Chin B.
        • Copeland A.
        • Gallo L.
        • et al.
        The fragility of statistically significant randomized controlled trials in plastic surgery.
        Plast Reconstr Surg. 2019; 144: 1238-1245
        • Shen C.
        • Shamsudeen I.
        • Farrokhyar F.
        • Sabri K.
        Fragility of results in ophthalmology randomized controlled trials: A systematic review.
        Ophthalmology. 2018; 125: 642-648
        • Levy D.M.
        • Kuhns B.D.
        • Chahal J.
        • Philippon M.J.
        • Kelly B.T.
        • Nho S.J.
        Hip arthroscopy outcomes with respect to patient acceptable symptomatic state and minimal clinically important difference.
        Arthroscopy. 2016; 32: 1877-1886
        • Nwachukwu B.U.
        • Chang B.
        • Beck E.C.
        • et al.
        How should we define clinically significant outcome improvement on the iHOT-12?.
        HSS J. 2019; 15: 103-108
        • Nwachukwu B.
        • Beck E.
        • Kunze K.
        • et al.
        Defining the MCID, PASS and SCB for arthroscopic hip preservation surgery at minimum five-year follow-up.
        Orthop J Sports Med. 2020; 8 (2325967120S00351)
        • Beck E.C.
        • Nwachukwu B.U.
        • Mehta N.
        • et al.
        Defining meaningful functional improvement on the visual analog scale for satisfaction at 2 years after hip arthroscopy for femoroacetabular impingement syndrome.
        Arthroscopy. 2020; 36: 734-742.e2