A prospective and observational clinical investigation evaluating the clinical outcomes of unstable distal radius fractures treated by the dynamic external fixator Galaxy Wrist
- Conditions
- S60-S69Injuries to the wrist and hand
- Registration Number
- DRKS00006758
- Lead Sponsor
- Orthofix Srl, , Bussolengo (Verona), Italy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
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
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;
- is assuming a not permitted concomitant medication which cannot be safely stopped;
- is having a concomitant treatment with a not permitted devices which cannot be safely removed;
- is participating other clinical trials or took part to a clinical study in the last 3 months;
- is likely to be lost to follow up.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method