S52.59
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Age = 18 years -Acute, closed, intra-articular distal radius fracture confirmed by imaging -Indication for surgical treatment with open reduction and internal fixation (ORIF) -Capacity to provide informed consent and written consent to participate in the study and attend the follow-up examinations
Exclusion criteria
Exclusion criteria: -Open fractures -Polytrauma with an Abbreviated Injury Scale (AIS) score = 3 if adequate follow-up cannot be ensured -Pre-existing symptoms and/or previous surgery involving the affected wrist, such as a known unstable scapholunate ligament injury, rheumatoid arthritis, or severe degenerative joint disease -Neurological disorders resulting in permanent impairment of hand function -Refusal to undergo arthroscopic examination -Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the total Patient-Rated Wrist Evaluation (PRWE) score between patients with and without concomitant wrist/carpal injuries at 12 months, 24 months, and 5 years after the fracture. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - PRWE score at 6 weeks, 3 months, and 6 months -DASH score at 3, 6, 12, and 24 months and at 5 years - Visual analogue scale (VAS) for pain at rest and during activity -Range of motion, including active flexion and extension, radial and ulnar deviation, and pronation and supination, reported both as absolute values and as a percentage of the contralateral side - Grip strength measured using a dynamometer in kilograms and compared with the contralateral side - Radiographic parameters: o Standard radiographs in anteroposterior, lateral, and oblique views obtained immediately postoperatively and at 6 weeks, 3, 6, 12, and 24 months, with optional imaging at 5 years oComputed tomography (CT) for the assessment of intra-articular reduction and complex fracture fragments oAssessment of post-traumatic osteoarthritis using a predefined scoring system, such as the modified Knirk and Jupiter classification or a study-specific radiographic osteoarthritis scale, at 12 and 24 months and at subsequent follow-up visits - Complications and reoperations, including infection, implant failure, and subsequent wrist procedures - Nerve-related adverse events, such as carpal tunnel syndrome | — |
Countries
Germany
Contacts
Universitätsklinikum Regensburg