Arthroscopic cuff repair Cuff tear / cuff ruptuur Bicepstenotomy / Bicepstenotomie Stage 2-3 Goutallier / stadium 2-3 Goutallier
Conditions
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
Sponsors
Performer: St. Antonius Ziekenhuis, Utrecht/Nieuwegein
Eligibility
Inclusion criteria
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
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 35 kg/m² - Time between surgery and MRI > 12 months - Fracture of the humeral head involved in the cuff tear
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 [24]. 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactNienke Wolterbeek
Afdeling Orthopedie St. Antonius Ziekenhuis Postbus 2500
Outcome results
None listed