Results of the Anser Clavicle Pin for treatment of Midshaft Clavicle Fractures
Phase 3
Recruiting
- Conditions
- clavicle fracturecollarbone break10005959
- Registration Number
- NL-OMON52512
- Lead Sponsor
- Rijnstate Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
• Displaced midshaft clavicle fracture Type 2B or 2C according to the Robinson
Classification
• Age >= 18 years,
• Surgery <=4 weeksafter trauma
Exclusion Criteria
• All patients deemed not fit for surgery by the anesthesiologist
• All patients with nonunion or previous malunion
• Patients <18 years
• Possible noncompliant patients (eg, alcohol and drug addiction, dementia)
• Additional neurovascular injury
• Pathologic fractures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measures will be union rate, complication rate and<br /><br>functional outcome scores.<br /><br>Union is defined as a 2/3rd circumferential cortical bridging between medial<br /><br>and lateral fragments on both radiographs as determined by the treating surgeon<br /><br>and an independent radiologist. Complication is defined as any general or<br /><br>implant-related adverse effect intra- and postoperatively. Functional Outcome<br /><br>scores will be measured with using the Constant score and DASH score at the 6<br /><br>weeks, 3 months and 1 year postoperative visits.</p><br>
- Secondary Outcome Measures
Name Time Method