Clinical effectiveness of supraspinatus tendon reconstruction using autogenous fascia latas for irreparable posterosuperior massive rotator cuff tears: study protocol for a randomized, controlled clinical trial

BACKGROUND: Supraspinatus tendon reconstruction (STR) was recently introduced as a new treatment option for irreparable posterosuperior massive rotator cuff tears (IPMRCT). STR was thought to be more advantageous than superior capsule reconstruction (SCR) for restoring supraspinatus (SSP) dynamics. However, there has been no prospective randomized controlled study on the early clinical efficacy of STR. METHODS: A single-site, prospective, observers and patients double-blinding randomized controlled trial was designed. Fifty-eight patients aged 50–85 years with IPMRCT will be randomized 1:1 to receive either STR or SCR. The clinical outcomes were evaluated using the American Society for Shoulder and Elbow Surgery (ASES) score, range of motion (ROM), visual analogue scale (VAS) for pain, acromiohumeral distance (AHD), Goutlliar grade for fatty infiltration in the SSP, Sugaya grade for the autogenous fascia latas, isokinetic muscle strength testing and surface electromyography (EMG) testing for shoulder abduction muscle strength and complications. DISCUSSION: The results of this study will contribute to the treatment algorithm of IPMRCT and assist surgeons in making treatment decisions. This is the first randomized controlled trial to compare the effects of STR and SCR for the treatment of IPMRCT. TRIAL REGISTRATION: We registered the trial in chictr.org.cn on July 17, 2023 (register number: ChiCTR2300073716). Items from the WHO trial registry were found within the protocol.