Abduction brace versus sling after arthroscopic cuff repair
Phase 3
Completed
- Conditions
- Cuff lesioncuff rupture10028302
- Registration Number
- NL-OMON37026
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Cuff lesion (primary procedure)
Subacromial decompression (optional secondary procedure)
Sufficient understanding of the Dutch language
Competent adults
Willing and able to comply to the study protocol
Exclusion Criteria
Age <18, >75
BMI >35
Diabetes mellitus
Chronic pain diseases, fibromyalgia
Current treatment with opiates
Immunocompromized/ HIV+
Labral repair
Lateral clavicle resection
Secondary suturing
Psychiatric patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main parameter of this study will be the difference in pain between the<br /><br>patients receiving an abduction brace and patients receiving a sling. This will<br /><br>be measured once preoperatively, six times postoperatively in the first 72<br /><br>hours, two daily in the first week and then weekly up to three months. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters:<br /><br>Constant score, WORC and EQ-5D score.<br /><br>Intra-operatively the size of the cuff tear will be classified by the operating<br /><br>Orthopaedic surgeon.<br /><br><br /><br>Others:<br /><br>Patient*s satisfaction<br /><br>Lenght of stay in hospital, age, BMI, gender, dominant/non-dominant hand, side,<br /><br>minor/major tear, use of NSAID and interscalene block.</p><br>