|- candidate number||8092|
|- NTR Number||NTR2343|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-mei-2010|
|- Secondary IDs||2008/040 METC UMCG|
|- Public Title||Functional and radiological outcome of non-surgical vs surgical treatment for the atraumatic cuff rupture after 1 year (COPACABANA trial).|
|- Scientific Title||Outcome of Non-surgical vs Surgical treatment fot the Atraumatic Cuff Rupture, Anatomy and Radiologically after 1 year (COPACABANA trial).|
|- hypothesis||Comparison between surgical vs non surgical treatment of an atraumatic cuff rupture. |
|- Healt Condition(s) or Problem(s) studied||Shoulder disorders , Subacromial impingement syndrome, Rupture, Rotator cuff, Atraumatic|
|- 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 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.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2010|
|- planned closingdate||1-jan-2014|
|- Target number of participants||108|
|- 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 NSAIDís.
|- Primary outcome||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.|
|- Secondary outcome||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.|
|- Timepoints||Follow-up on both groups will take place at 6 weeks, 3, 6 and 12 months after commencement of treatment. At 12 months follow up a second MRI of the affected shoulder will be performed.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| F.O. Lambers Heerspink|
|- CONTACT for SCIENTIFIC QUERIES|| F.O. Lambers Heerspink|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Martini Hospital Groningen|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG), Martini Hospital Groningen|
|- Brief summary||Tendinous degeneration of the rotator cuff of the shoulder is a frequently observed disorder. With subsequent atraumatic rotator cuff tendon rupture it can give rise to long lasting symptoms and impairment, although degenerative ruptures are also observed in asymptomatic elderly individuals. Treatment can be non-surgically or surgically. Reasonable results are reported from both treatment modalities. No studies of quality are performed to compare these treatment modalities.|
The objective of this study is whether there is an difference in outcome between surgical repair and non-surgical treatment of an atraumatic rotator cuff tendon rupture.
A randomized controlled trial will be conducted. Patients, aged between 45 and 75 years with an atraumatic rotator cuff tendon rupture as diagnosed on MRI will be included. Exclusion criteria are traumatic rotator cuff tendon rupture, frozen shoulder, diabetes mellitus. Patients are randomized in two groups. The non-surgical treatment consists of physical therapy, acoording to a standardised format, NSAIDís and if indicated subacromial infiltration of local anesthetic and corticosteroids. Surgical therapy is conducted under general or regional anesthesia. An acromioplasty with repair of the rotator cuff tendon will be performed, in a standardized way.
Follow-up visits will take place after 6 weeks, 3 months, 6 months and 1 year postoperatively. One year postoperatively a second MRI will be performed of all patients.
At all measurement points, the Constant score will be assessed. Secondary outcome measures are the Dutch simple shoulder score, a visual analogue scale for pain and impairment, the Goutaillier score which defines fatty degeneration of the rotator cuff, and measurements of the anatomical location of the rotator cuff rupture, integrity of the rotator cuff and economic evaluation.
In current practice both treatments are being performed. There is a lack of studies of good quality which compare surgical vs. non-surgical treatment of rotator cuff tendon rupture. This randomized controlled trial has been designed to determine whether the surgical treatment of a rotator cuff tendon rupture gives a better functional outcome than non-surgical treatment.
|- Main changes (audit trail)|
|- RECORD||27-mei-2010 - 5-jun-2010|