The Anser Clavicle Pin will be a viable option in the surgical management of midshaft clavicle fractures.
ID
Bron
Verkorte titel
Aandoening
Displaced midshaft clavicle fractures
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Functional outcome scores as measured by the Constant Murley Score (CMS) and the Disabilities of Arm, Shoulder and Hand (DASH).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The Anser Clavicle Pin will be a viable option in the surgical management of midshaft clavicle fractures.
Onderzoeksopzet
Preop, Operation, 1 week, 6 weeks, 3 months, 1 year
Onderzoeksproduct en/of interventie
Surgical placement of Anser Clavicle Pin
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification
• Age ≥ 18 years
• Surgery performed within 4 weeks after trauma
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9061 |
| Ander register | CMO Arnhem-Nijmegen : CMO 2018-4053 |