Cost-effectiveness of biceps tenotomy with or without cuff repair in patients with stage 2-3 Goutallier fatty degenerative cuff lesions. A randomized controlled multicenter trial.
- Conditions
- Rototor cuff lesionshoulder lesion10043237
- Registration Number
- NL-OMON47699
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 172
* *60 years of age
* Willing and able to comply with the study protocol
* Signed informed consent
* Cuff lesion, involving the supraspinatus and or infraspinatus tendon, with at
least one of the involved tendons having stage 2-3 Goutallier fatty
infiltration
* Peroperative pathologic involvement of the long head of the biceps tendon.
Including: (minor signs of) degeneration, or signs of inflammation, or
instability (subluxation or dislocation), or traumatic (partial tear, SLAP
(Superior Labrum from Anterior to Posterior) lesions)
* History of shoulder complaints > 6 months suggestive for a degenerative
rotator cuff with or without non-significant preceding trauma
* Sufficient understanding of the Dutch language
* Cuff arthropathy according Hamada classification > grade 2
* Pseudoparalysis
* Full subscapularis tendon tear (delamination or partial avulsion accepted)
* Injury of the teres minor tendon
* Peroperative fully healthy macroscopic aspect of the long head of the biceps
tendon
* Mainly complaints from an arthrotic acromioclavicular joint and less from a
subacromial origin, 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 MRI and peroperative findings
* Unsuccessful surgery in the affected shoulder in history or surgery in the
affected shoulder < 1 year ago
* Previous rotator cuff repair on the ipsilateral shoulder.
* Ipsilateral neurological pathology possibly affecting functional outcome
* Full tear of the biceps tendon
* Cervical spine pathology affecting the functional outcome
* Body Mass Index (BMI) > 35 kg/m²
* Time between surgery and MRI > 6 months
* Fracture of the humeral head involved in the cuff tear
* MRI not performed preoperative
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary parameter is the rotator cuff specific quality of life (Western<br /><br>Ontario Rotator Cuff index)) on the short term (6 months after surgery). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are quality of life at 1 year after surgery and function<br /><br>(glenohumeral range of motion, Constant-Murley Score), recovery status, pain<br /><br>(Visual Analogue Scale), economic evaluation, satisfaction of treatment on the<br /><br>short and long term and re-tear rate at 6 months determined with an ultrasound.</p><br>