A Multicenter Randomized Controlled Trial Comparing Single-Row With Double-Row Fixation in Arthroscopic Rotator Cuff Repair: Long-Term Follow-up.

"One or more of the authors has declared the following potential conflict of interest or source of funding: P.L. has received speaking fees from Wright Medical. P.M. has received speaking fees from ConMed and educational support from ConMed, Arthrex, Ossur, and Zimmer Biomet. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto."

"One or more of the authors has declared the following potential conflict of interest or source of funding: P.L. has received speaking fees from Wright Medical. P.M. has received speaking fees from ConMed and educational support from ConMed, Arthrex, Ossur, and Zimmer Biomet. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto."

"The methodology of the trial was described in a previous article. This was a double-blinded randomized clinical trial with two 1:1 parallel groups conducted at 2 university teaching hospitals. Recruitment for the original trial occurred between June 2007 and June 2009, and final evaluations took place between November 2017 and January 2020. The inclusion criteria were identical to those of the original randomized controlled trial, and the exclusion criteria were patients who were excluded from the original study, those who withdrew from the original study, and those who were unable or unwilling to provide written informed consent. The original study used computer-generated blocked randomization with variable block sizes. Sealed opaque envelopes were used to determine group allocation, and the envelopes were opened by the circulating nurse in the operating room once eligibility was confirmed. No changes in trial methodology or treatment outcomes occurred after the initiation of the trial. Institutional review board approval was obtained. This trial was registered at www.clinicaltrials.gov (NCT00508183). There was no external funding for this trial. Registration:: NCT00508183 (ClinicalTrials.gov identifier)."