DRKS00006758
Recruiting
N/A
A prospective and observational clinical investigation evaluating the clinical outcomes of unstable distal radius fractures treated by the dynamic external fixator Galaxy Wrist - OCI 1401
Orthofix Srl, , Bussolengo (Verona), Italy0 sites120 target enrollmentSeptember 25, 2014
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- S60-S69
- Sponsor
- Orthofix Srl, , Bussolengo (Verona), Italy
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •INCLUSION CRITERIA
- •Patient will be eligible for inclusion in the investigation if he/she:
- •\- is at least 18 years old at time of ICF signature;
- •\- compliant to sign ICF;
- •\- has a fresh (\= 14 days since the time of the injury), intra\- or extra\-articular, unstable Distal Radius Fracture(s) (DRF(s)) with or without soft tissue damage requiring a surgical management;
- •\- has a regular indication for surgical intervention with Galaxy Wrist, in the bridging configuration, up to the surgeon decision.
Exclusion Criteria
- •EXCLUSION CRITERIA
- •Patient will be excluded from participation in the investigation if he/she:
- •\- has bilateral DRFs;
- •\- has carpal combined injuries/fractures;
- •\- has rheumatoid arthritis;
- •\- has previous DRF/arthrodesis;
- •\- has a medical condition that is a contraindication according to the manufacturer instruction for use;
- •\- has suspected foreign body sensitivity or declared allergy to the device components which contact the patient;
- •\- has any conditions which in the Investigator’s opinion may interfere with the study execution or due to which the patient should not participate for safety reasons;
- •\- is unwilling or incapable of following postoperative care instructions due to mental or physiological condition;
Outcomes
Primary Outcomes
Not specified
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