Advertisement

Regarding “A Prospective Randomized Trial Comparing Suture Bridge and Medially Based Single-Row Rotator Cuff Repair in Medium-Sized Supraspinatus Tears”

      We read with great interest the article “A Prospective Randomized Controlled Trial Comparing Suture Bridge and Medially Based Single-Row Rotator Cuff Repair in Medium-Sized Supraspinatus Tear” published recently in your journal.
      • Yamakado K.
      A prospective randomized trial comparing suture bridge and medially based single-row rotator cuff repair in medium-sized supraspinatus tears.
      The article compared clinical and imaging outcomes between 2 commonly used knot configurations. However, we would like to raise several concerns that need to be addressed by the author.
      The study is highly underpowered (power = 0.08, based on the UCLA score). Thus, it may be unlikely to recognize any actual difference between the groups.
      • Akobeng A.K.
      Understanding randomised controlled trials.
      The sample size calculated by the author, based on an unpublished data of a pilot study, is much less compared with that suggested in previous literature. For instance, according to the data extracted from similar research by Carbonel et al.,
      • Carbonel I.
      • Martinez A.A.
      • Calvo A.
      • Ripalda J.
      • Herrera A.
      Single-row versus double-row arthroscopic repair in the treatment of rotator cuff tears: A prospective randomized clinical study.
      183 patients are required in each group to achieve a statistical power of 0.8 (effect size: 0.29, and the probability of type 1 error: 0.05).
      The author didn’t discuss the particulars of randomization. The author obtained an equal sample size in both the groups, which indicates that they must have implemented some kind of randomization blocking. Furthermore, there is an improper description regarding the method of sequence generation and allocation concealment. All these factors should be explained more, as they increase the chances of selection bias.
      • Kahan B.C.
      • Rehal S.
      • Cro S.
      Risk of selection bias in randomised trials.
      The latter can reverse the randomization process, leading to biased estimations of treatment effect and inaccurate inferences.
      • Kahan B.C.
      • Rehal S.
      • Cro S.
      Risk of selection bias in randomised trials.
      Preoperative group characteristics that are potential confounders, including the proportion of degenerative tear, fatty infiltration in the rotator cuff, delamination of the tendon, and tendon retraction, should have been reported by the author.
      • Roth K.M.
      • Warth R.J.
      • Lee J.T.
      • Millett P.J.
      • ElAttrache N.S.
      Arthroscopic single-row versus double-row repair for full-thickness posterosuperior rotator cuff tears: A critical analysis review.
      These descriptions would have also allowed us to access the success of randomization processes, and to judge for generalizability of the data.
      • Burgess D.C.
      • Gebski V.J.
      • Keech A.C.
      Baseline data in clinical trials.
      Furthermore, the author didn’t discuss regarding inter-evaluator calibration, which can make the results less reliable.
      Lastly, there is a discrepancy in the number of patients present in the study for review. According to the abstract, Results section, Table 1, and Table 3 of Yamakado et al.,
      • Yamakado K.
      A prospective randomized trial comparing suture bridge and medially based single-row rotator cuff repair in medium-sized supraspinatus tears.
      92 patients were available for analysis after 1 year. However, after the exclusion of 15 patients (as per the CONSORT flow chart), 91 patients should have been present at 1-year follow-up. Furthermore, at the 2-year follow up, the abstract suggests 74 patients, whereas the CONSORT flow chart and the text in the result section indicate that 75 patients were available.
      We would like to conclude here by complimenting the author for presenting an essential research question. However, the readers of the article must be sensitized regarding the shortcomings of the study. Future studies in this topic should consider the point suggested in this letter to avoid any methodologic and reporting inaccuracies.

      Supplementary Data

      References

        • Yamakado K.
        A prospective randomized trial comparing suture bridge and medially based single-row rotator cuff repair in medium-sized supraspinatus tears.
        Arthroscopy. 2019; 35: 2803-2813
        • Akobeng A.K.
        Understanding randomised controlled trials.
        Arch Dis Child. 2005; 90: 840-844
        • Carbonel I.
        • Martinez A.A.
        • Calvo A.
        • Ripalda J.
        • Herrera A.
        Single-row versus double-row arthroscopic repair in the treatment of rotator cuff tears: A prospective randomized clinical study.
        Int Orthop. 2012; 36: 1877-1883
        • Kahan B.C.
        • Rehal S.
        • Cro S.
        Risk of selection bias in randomised trials.
        Trials. 2015; 16: 405
        • Roth K.M.
        • Warth R.J.
        • Lee J.T.
        • Millett P.J.
        • ElAttrache N.S.
        Arthroscopic single-row versus double-row repair for full-thickness posterosuperior rotator cuff tears: A critical analysis review.
        JBJS Rev. 2014; 2 (201402070-00007)01874474
        • Burgess D.C.
        • Gebski V.J.
        • Keech A.C.
        Baseline data in clinical trials.
        Med J Aust. 2003; 179: 105-107