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Functional and radiological outcome of non-surgical vs surgical treatment for the atraumatic cuff rupture after 1 year (COPACABANA trial).

Outcome of Non-surgical vs Surgical treatment fot the Atraumatic Cuff Rupture, Anatomy and Radiologically after 1 year (COPACABANA trial).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26949
Enrollment
108
Registered
2010-05-27
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atraumatic (atraumatisch) rotator cuff rupture (rotator cuff ruptuur) subacromial impingement syndrome (impingement syndroom) shoulder (schouder)

Interventions

1. 54 patients are randomized for acromioplasty with surgical repair of rotator cuff
2. 54 patients are randomized for conservative therapy consisting of physical therapy, subacromial infiltration with local analgesic and corticosteroids, analgesic medication, for example NSAID’s.

Sponsors

UMCG Martini Hospital Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In all patients referred to the department of Orthopaedic surgery and Rehabilitation of both the Martini Hospital and the University Medical Centre in Groningen, aged between 45 en 75 years, with a clinically suspected atraumatic rotator cuff rupture a MRI scan will be performed. If on the MRI of the affected shoulder 2 independent assessors diagnose a full thickness rotator cuff rupture with degenerative characteristics, the patient will be included in this study.

Exclusion criteria

Exclusion criteria: Exclusion criteria are traumatic rotator cuff rupture, no signs of degeneration on MRI, previous surgical treatment of the shoulder, frozen shoulder, radiological and symptomatic osteoarthritis of the gleno-humeral or acromio-clavicular joint, (rheumatoid) arthritis, diabetes mellitus and cognitive disorders, neurological disease or language barriers impairing participation.

Design outcomes

Secondary

MeasureTime frame
Secondary outcome measurements are the Dutch Simple Shoulder Test, the Visual Analog Scale for pain and restriction, the Goutallier score, anatomical localization of the rotator cuff rupture, integrity of the rotator cuff and economic evaluation.

Primary

MeasureTime frame
Functional outcome is the primary outcome measurement. The Constant Murley Score will be used. This score system combines a shoulder function test (65 points) with a subjective evaluation of complaints by the patient (35 points). The Constant Murley Score is a valid score for shoulder function and rotator cuff ruptures and repairs.

Contacts

Public ContactF.O. Lambers Heerspink

PO Box 30.033

lamberfo@mzh.nl+31 (0)50 5247723

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)