Open vs arthroscopic surgery in distal clavicle excision: a randomized controlled pilot trial
- Conditions
- Short term pain experienceFunctional shoulder movementOpen surgery / arthroscopic surgery Distal clavicle excision
- Registration Number
- NL-OMON28257
- Lead Sponsor
- Flevoziekenhuis Almere
- Brief Summary
one
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
All participants must have an indication for distal clavicle excision based on AC osteolysis, post-traumatic injury or arthrosis/arthritis confirmed by ultrasound, x-ray and physical examination. Indication is determined by the orthopaedic surgeon when conservative treatment (physical therapy, rest, corticosteroid injections) fails to improve the shoulder function and pain.
Age: at least 18 years old
Exclusion Criteria
-Not able to read and speak Dutch language sufficiently to complete the questionnaires
-Distal clavicle excision in the past
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to examine the difference in daily pain experience between open and arthroscopic surgery in distal clavicle excision for patients with acromioclavicular pathology measured with the NRS (in rest and movement) in the first 6 weeks after surgery
- Secondary Outcome Measures
Name Time Method •Daily shoulder function measured with the DASH (pre-operatively, 6 weeks, 3 months, 6 months, 12 months) <br /><br>•Pain measured with the NRS (pre-operatively, 6 weeks, 3 months, 6 months, 12 months)<br /><br>•Adverse events (frozen shoulder) diagnosed by physical examination<br /><br>•Number of wound infections<br /><br>•Time until return to work <br /><br>•Total costs of surgery <br /><br>•Total costs of the revalidation process <br>