S60-S69
Conditions
Interventions
Group 1: Patients who have been diagnosed with instable distal radius fracture(s) and which will be treated with the CE-certified medical device Galaxy Wrist, a dynamic external fixator, in the bridge
Sponsors
Orthofix Srl, , Bussolengo (Verona), Italy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OBJECTIVES To assess the clinical performance and the safety of Galaxy Wrist in treating/healing DRFs on a representative population of patients and users observed in the normal clinical practice conditions. EFFICACY ENDPOINTS The clinical performance of Galaxy Wrist in treating/healing DRFs will be assessed by the following clinical efficacy endpoints: - “Patient-Rated Wrist Evaluation” (PRWE) score (patientquestionnaire); - range of wrist motion (ROM); - grip strength; - lateral pinch; - “Disabilities of the Arm, Shoulder and Hand” (DASH) score (patientquestionnaire); - radiographic measurements (Bohler angle in the anterior-posterior and lateral views) - Visual Analogue Scale (VAS). SAFETY ENDPOINTS The safety of Galaxy Wrist in treating/healing DRFs will be assessed by the following safety endpoints: - frequencies and the nature of the Serious Adverse Device Effects (SADEs); - frequencies and the nature of the Adverse Device Effects (ADEs); - frequencies and the nature of Investigational Medical Device Deficiencies (IMDDs). | — |
Countries
Germany, Italy
Contacts
Public ContactCasper Grim
Klinikum OsnabrückKlinik für Orthopädie, Unfall und Handchirurgie
Outcome results
None listed