No registrations found.
ID
Source
Brief title
Health condition
Displaced midshaft clavicle fractures
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional outcome scores as measured by the Constant Murley Score (CMS) and the Disabilities of Arm, Shoulder and Hand (DASH).
Secondary outcome
Union rate, complication rate, closed reduction rate, operative time, image-intensifier time, hospital stay, post-operative pain reduction, re-operations, return to work, health related quality of life and patient satisfaction.
Background summary
The goals of this study are to evaluate the union rate, patient satisfaction and functional results of the Anser Clavicle Pin in 100 patients with displaced midshaft clavicle fractures.
The primary outcome measures are functional outcome scores as measured by the Constant Murley Score (CMS) and the Disabilities of Arm, Shoulder and Hand (DASH).
Secondary outcomes are union rate, complication rate, closed reduction rate, operative time, image-intensifier time, hospital stay, post-operative pain reduction, re-operations, return to work, health related quality of life and patient satisfaction.
Study objective
The Anser Clavicle Pin will be a viable option in the surgical management of midshaft clavicle fractures.
Study design
Preop, Operation, 1 week, 6 weeks, 3 months, 1 year
Intervention
Surgical placement of Anser Clavicle Pin
Inclusion criteria
• Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification
• Age ≥ 18 years
• Surgery performed within 4 weeks after trauma
Exclusion criteria
• All patients deemed not fit for surgery by the anesthesiologist
• All patients with nonunion or previous malunion
• Possible noncompliant patients (eg, alcohol and drug addiction, dementia)
• Additional neurovascular injury
• Pathologic fractures
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9061 |
| Other | CMO Arnhem-Nijmegen : CMO 2018-4053 |