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|
|- candidate number||15448|
|- NTR Number||NTR4182|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-sep-2013|
|- Secondary IDs|| |
|- Public Title||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|
|- Scientific Title||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|
|- hypothesis||• 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.
|- Healt Condition(s) or Problem(s) studied||Stage 2-3 Goutallier , Cuff tear, Bicepstenotomy|
|- Inclusion criteria||- Competent men and women older than 18 years|
- Willing and able to comply with the study protocol
- Signed informed consent
- Cuff lesion with at least one of the involved tendons having stage 2-3 Goutallier fatty infiltration
- Involvement of the long head of the biceps tendon (one or more of these clinical tests found positive: painful bicepsgroove, Speed test, Yergason’s test, O’Brien’s test, Habermeyer’s test or obvious tendinopathy on MRI) or preoperative pathologic aspect of its intra-articular part
- Failed conservative treatment (> 6 months) of their subacromial pain syndrome
- Sufficient understanding of the Dutch language
|- Exclusion criteria||- Cuff arthropathy according Hamada classification > grade 2|
- Full subscapularis tendon tear (delamination or partial avulsion accepted)
- Injury of the teres minor tendon
- Mainly complaints from acromioclavicular origine compared to subacromial pains, determined clinically or by subacromial/acromioclavicular infiltration (acromioclavicular joint resection is not an exclusion criteria)
- Shoulder instability for which labral repair is indicated
- Irreparable rotator cuff tear based on preoperative MRI, or on peroperative findings.
- Unsuccessful surgery in the affected shoulder in history or surgery in the affected shoulder < 1 year ago
- Ipsilateral neurological pathology possibly affecting functional outcome
- Full tear of the biceps tendon
- Unimpaired biceps tendon during arthroscopy
- Cervical spine pathology affecting the functional outcome
- Body Mass Index (BMI) > 35 kg/m˛
- Time between surgery and MRI > 12 months
- Fracture of the humeral head involved in the cuff tear
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2014|
|- planned closingdate||1-aug-2020|
|- Target number of participants||128|
|- Interventions||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.
|- Primary outcome||Primary outcome will be quality of life (QOL) measured by the Western Ontario Rotator Cuff (WORC) Index 6 months after surgery. The WORC index is a disease-specific shoulder questionnaire, originally developed at the University of Western Ontario and has been validated in Dutch . It measures quality of life in patients with rotator cuff disease on 5 domains: physical symptoms, sports and recreation, work, lifestyle and emotions. Each item is scored on a non-hatched 100-mm visual analogue scale (VAS). Total score ranges from 0 to 2100, with a higher score indicating a lower quality of life. All items are converted to a score from 0-100%, with a higher score indicating a higher QOL. |
In addition, an economic analysis will be performed from a societal perspective and a budget impact analysis from societal, government and insurer perspective.
|- Secondary outcome||Secondary outcomes include:|
• Difference between groups:
o General health, measured by RAND-36
o Quality of life, measured by EQ-5D-5L
o Pain, measured by the VAS score
o Function short term (≤ 6 months) and long term (> 6 months – 5 years), measured by the Constant Murley score and glenohumeral range of motion
• Re-tear rate at 6 months determined by ultrasound
• Productivity losses measured by the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P).
• Relation between participants functional change, their expectation and their satisfaction of treatment.
• Complication rate and adverse events.
|- Timepoints||Preoperatively (baseline)
Postoperatively: 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 3 years, 4 years. 5 years.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Nienke Wolterbeek|
|- CONTACT for SCIENTIFIC QUERIES|| Nienke Wolterbeek|
|- Sponsor/Initiator ||Sint Antonius Ziekenhuis|
(Source(s) of Monetary or Material Support)
|Fund = Initiator = Sponsor|
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||23-sep-2013 - 2-okt-2013|
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