this multicentre randomized controlled non-inferiority 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.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary parameters are quality of life at 1 year after surgery and function
(glenohumeral range of motion, Constant-Murley Score), recovery status, pain
(Visual Analogue Scale), economic evaluation, satisfaction of treatment on the
short and long term and re-tear rate at 6 months determined with an ultrasound.
Background summary
For patients who are diagnosed with lesions of the rotator cuff that present
advanced levels of fatty degeneration, arthroscopic repair of the rotator cuff
remains controversial despite several case series demonstrating significant
clinical improvement in this patient category. This controversy can be
attributed to the frequently reported high failure rate of the tendon fixation
and the fact that it remains unclear why repair for these tears result in
significant clinical improvement independent of the occurrence of such a
re-tear. Recent publications have reported comparable clinical improvements
when merely a tenotomy or tenodesis of the long head of the biceps tendon was
performed and the rotator cuff tear was left untreated. These observations
raise questions on the value of performing the more extensive and therefore
expensive cuff repairs in degenerative cuff tears. Even more, rehabilitation
after an isolated tenotomy is much less cumbersome as compared to
rehabilitation after rotator cuff repair and, therefore, might result in
improved patient satisfaction. Therefore, the goal of this trial is to study
the short term difference in function and quality of life between patients
undergoing arthroscopic cuff repair with an additional bicepstenotomy or an
isolated bicepstenotomy and to include an economic evaluation.
Study objective
this multicentre randomized controlled non-inferiority 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.
Study design
This study will be a randomized (1:1 ratio) controlled trial, including an
economic evaluation. Due to the obvious differences in post-operative
rehabilitation protocols, patients, surgeons and researchers will not be
blinded for treatment.
Intervention
One group which will undergo biceps tenotomy without cuff repair (N=86) and the
other group will undergo biceps tenotomy with repair of the rotator cuff
(N=86). Postoperative rehabilitation will be directly functional for the
patients receiving isolated tenotomy of the long head of the biceps tendon
(patients are allowed to use an antalgic shoulder-immobilizer) and 6 weeks of
immobilization for patients who underwent a tenotomy with a cuff repair.
Study burden and risks
The current standard treatment for this specific patient group is subject of
debate and at this time depends mostly on the preference of the orthopaedic
surgeon varying from a conservative treatment (physiotherapy, subacromial
corticosteriod infiltration, use of analgesia), an arthroscopic bicepstenotomy
is performed with or without a cuff repair, or implantation of a reversed
shoulder prosthesis. In this study, patients will undergo bicepstenotomy with
or without cuff repair. Both treatments are accepted procedures and within our
study population indicated surgical options. Therefore this study does not
involve additional risks.
Soestwetering 1
Utrecht 3543 AZ
NL
Soestwetering 1
Utrecht 3543 AZ
NL
Listed location countries
Age
Inclusion criteria
* *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
Exclusion criteria
* 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54313.100.15 |
| OMON | NL-OMON26658 |