The effect of conjoint tendon release on pain and internal rotation following reverse total shoulder arthroplasty: a prospective randomised controlled trial

Participants in this study will be adults who are undergoing reverse total shoulder arthroplasty. The intervention is conjoint tendon release which will be performed at the same time and approach for the arthroplasty procedure. The conjoint tendon is a tendon at the front of the shoulder which is comprised of the short head of biceps and coracobrachialis tendons and attaches to a bony structure on the shoulder blade (scapula) called the coracoid. A reverse total shoulder arthroplasty is an operation performed to replace the ball and socket of the shoulder joint and swaps the position of both. Recent evidence has shown that conjoint tendon irritation can cause stiffness and pain in patients undergoing reverse total shoulder arthroplasty, so a conjoint tendon release may help resolve this issue. Releasing the conjoint tendon involves incising it during the same initial operation for reverse shoulder arthroplasty to reduce the risk of stiffness and pain. Conjoint tendon release will be performed in conjunction with the primary rTSA that patients will have already been planned for. This additional procedure does not require a separate surgical incision or approach, and should not significantly prolong the timing of surgery. The surgery will take approximately one hour and additional 20 minutes for conjoint tendon release. There are some theoretical risks which will be outlined below. Surgical risks include: Anterior instability, potential neurovascular damage Surgical technique of open conjoint tendon release does not require a new incision and it is completed within the existing anatomical field of the surgical approach. There is a theoretical risk of further bleeding and neurovascular injury from the extra procedure of incising the conjoint tendon such as musculocutaneous nerve. The operations will be performed by expert shoulder surgeons who will minimise such risk intraoperatively. The main procedure to be performed for this study will be conjoint tendon release at coracoid insertion or not. Other procedures would include reverse total shoulder arthroplasty and follow up questionnaires and assessment. Follow up activities include clinical examination for range of motion (as part of normal follow up post operatively), questionnaires such as visual analogue scale for pain, SSV Subjective Shoulder Value, ASES American Shoulder and Elbow Society score. The hospital stay will be standard 1 night as per usual post op reverse total shoulder protocol, which may be dependent on patient comorbidities, discomfort and safety levels. This should not be altered by the conjoint tendon release. More detail about surgical approach is in the protocol The intervention will be delivered once per participant in the randomised group. We are aiming for 80 participants so would be 40 interventions for this study. The study will be undertaken over a period of 2-5 years (depending on recruitment and participant numbers) Confidentiality and integrity will be maintained by storing randomisation schedules in secure electronic systems with restricted access, excluding the outcome assessors. The hospital records will be used to monitor fidelity of the procedures. Surgeons cannot be blinded but the patients and outcome assessors will be blinded to group allocation.