Cost-effectiveness of biceps tenotomy with or without cuff repair in patients with stage 2-3 Goutallier fatty degenerative cuff lesions. A randomized controlled trial

this multicentre randomized controlled trial is designed to compare the short and long term outcome of patients who underwent an arthroscopic tenotomy of the long head of the biceps tendon with or without a cuff repair. The primary parameter is the rotator cuff specific quality of life (Western Ontario Rotator Cuff index)) on the short term (6 months after surgery). Secondary parameters are quality of life on the long term and function (glenohumeral range of motion, Constant Murley score), recovery status, pain (Visual Analogue Scale), productivity losses (TiC-P), satisfaction of treatment on the short and long term and re-tear rate at 6 months determined with an ultrasound. We hypothesize that patients who undergo an isolated tenotomy of the long head of the biceps tendon in the presence of a degenerative rotator cuff tear, stage 2-3 Goutallier fatty infiltration, will have better functional results and quality of life, 3 and 6 months after surgery as compared to patients undergoing tenotomy combined with rotator cuff repair, due to the less extensive procedure and the less restrictive rehabilitation protocol. At 1 year after surgery and on the long term (up to 5 years after surgery), we assume equal improvement of function results and quality of life in both groups and reduced costs with isolated tenotomy treatment.

• We expect more functional improvement and a higher level of quality of life 3 and 6 months postoperatively for patients undergoing an isolated bicesptenotomy (measured with: WORC, RAND-36, EQ-5D-5L, VAS pain, CMS, glenohumeral range of motion).

• We expect after one year and up to five years that functional improvement and quality of life will be equal for both groups (measured with: WORC, RAND-36, EQ-5D-5L, VAS pain, CMS, glenohumeral range of motion).

• We expect that patients undergoing an isolated bicesptenotomy will resume work / daily activities much faster because after surgery their shoulders are directly functional without any restrictions. The patients who undergo a rotator cuff repair will be immobilized for 6 weeks in an abduction or anti-rotation sling and will need an additional 6 weeks for functional recover, which will lead to more productivity losses.

• We expect that surgery for patients undergoing an isolated bicesptenotomy will be shorter and less surgical instruments/materials will be used.

• We expect with an equally improvement of function in both groups, that an isolated bicepstenotomy in the setting of a grade 2-3 Goutallier FI rotator cuff tear is much more cost-effective than performing an additional cuff repair as standard therapy.

• We expect adverse events to occur more frequently in the cuff repair group.

Preoperatively (baseline)
Postoperatively: 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 3 years, 4 years. 5 years.

The procedures are only performed by an orthopaedic surgeon experienced in arthroscopic rotator cuff surgery. Surgical technique, such as patient positioning, portal placement and the use of assistive instruments such as knives, forceps, shavers and RF-probe will be done or used according to the standard protocol at the site. The used of preoperative antibiotics, technique used for repair (if possible double row rotator cuff repair) and post-operative rehabilitation protocols will be standardized. During the arthroscopic procedure the following anatomical structures will be evaluated: capsula, synovium, bursae, labrum, long head of biceps tendon (aspect, mobility), rotator cuff tendons/ muscles (aspect, mobility), articular surface, subacromial space and ligaments.



Group 1: bicepstenotomy with cuff repair:
After surgery they will be immobilized for 6 weeks in an abduction or anti-rotation sling. Two weeks after surgery the patients will visit the outpatient department for wound inspection and removal of stitches. After six and twelve weeks they will be checked on function and persistence of symptoms. Patients will be referred to a physiotherapist immediately after discharge of the hospital to assist in the passive mobilization of the shoulder during the first 6 weeks, and the active mobilization after 6 weeks.



Group 2: bicepstenotomy without cuff repair:
After surgery shoulders are directly function without any restrictions. A simple sling can be given to support the arm during the recovery period from surgery.