postoperative immobilization in arthroscopic rotator cuff repair; the use of botulinum toxin A
Completed
- Conditions
- rotator cuff tearshoulder tendon tear100432371002445010041297
- Registration Number
- NL-OMON36425
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
- willing and able to participate in the study protocol
- age * 18 years
- symptomatic tear of the supraspinatus tendon, not responding to conservative treatment.
- male and female patients
Exclusion Criteria
- hypersensitivity to Botox
- neuromuscular diseases
- diabetes
- pregnant or nursing
- aged under eighteen
- a language barrier
- mental disabilities
- additional injury as in fractures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine whether postoperative immobilization of the rotator cuff, after<br /><br>arthroscopic rotator cuff repair using botulinum toxin, leads to improved<br /><br>postoperative pain. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine whether postoperative immobilization of the rotator cuff, after<br /><br>arthroscopic rotator cuff repair using botulinum toxin, leads to no more<br /><br>surgical failures than using traditional six-week sling immobilization.<br /><br>Endpoint: re-tears in the supra/ infraspinatus tendon (ultra sound, mri).To<br /><br>determine whether postoperative immobilization of the rotator cuff, after<br /><br>arthroscopic rotator cuff repair using botulinum toxin, leads to improved<br /><br>functional outcome and strength.<br /><br><br /><br>To determine the difference in electrical muscle activity (EMG) and if the<br /><br>surgery leads to a spontaneous reversible neuropraxia.</p><br>