Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philipps University Marburg | OTHER |
This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires.
The aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (RCT). The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a pilot study it is intended to generate a study hypothesis for the main RCT.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteosynthesis with palmar locking plate | Procedure | |||
| Osteosynthesis with external fixator | Procedure | |||
| Osteosynthesis with Kirschner wires | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status measured by DASH questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | ||
| Range of motion (ROM) | ||
| Grip strength |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Schädel-Höpfner, MD | Contact | +49 211 8104405 | schaedel@uni-duesseldorf.de |
| Name | Affiliation | Role |
|---|---|---|
| Michael Schädel-Höpfner, MD | Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Trauma and Hand Surgery, University Hospital | Recruiting | Düsseldorf | D - 40225 | Germany |
Not provided
| ID | Term |
|---|---|
| D003100 | Colles' Fracture |
| D011885 | Radius Fractures |
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D000072039 | Fracture Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D016267 | External Fixators |
| D001864 | Bone Wires |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Radiological parameters |
| Feasibility |
| D014947 |
| Wounds and Injuries |
| D050723 | Fractures, Bone |
| D005543 | Forearm Injuries |
| D001134 | Arm Injuries |
| D014954 | Wrist Injuries |
| D009984 |
| Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D053831 | Surgical Fixation Devices |
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |