Effectiveness of Immobilization in the Postoperative Analgesia of Patients With Distal Radius Fracture Treated With Volar Locking Plating: a Prospective, Randomized Clinical Trial
| Registry | NCT03186963 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 39 (Actual) |
| Sponsor | University of Sao Paulo (Other) |
| Conditions | Radius Fracture Distal |
| Interventions | No immobilization, Volar splint (Procedure) |
| Dates | start 2013-05-01, primary completion 2017-06-01, completion 2017-11-01, first posted 2017-06-14, last updated 2018-03-16 |
| Locations | 1 site in Brazil |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Radius Fracture Distal All trials of No immobilization All trials of Volar splint
The purpose of this study is to determine wether postoperative immobilization is effective in controlling the pain of patients with intra-articular distal radius fractures treated with volar locking plate fixation. The study hypotheses is that postoperative immobilization does not enhance the analgesia of these patients.
Volar locking plate fixation has been used as the gold standard treatment for intra-articular distal radius fractures. The need for postoperative immobilization after this type of fixation is controversial, with some authors advocating its use for analgesia. Conversely, the use of immobilization might retard the recovery of wrist range of motion and function. The objective of this study is to compare the level of pain and function of patients undergoing surgical fixation of distal radius fractures using or not postoperative immobilization. Patients will be randomly assigned to receive a plaster splint or conventional dressing immediately after the surgery. The main outcome is the level of pain in the first two weeks postoperatively.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| No immobilization | Experimental | Procedure: No immobilization | Patients receive a conventional dressing made with gauze, cotton padding and inelastic bandage after the surgery. They are instructed to start light wrist movements on the first postoperative day and progress as tolerated, beginning rehabilitation with physiotherapy after 2 weeks postoperatively. |
| Volar splint | Active comparator | Procedure: Volar splint | Patients receive a volar plaster splint with inelastic bandage after the surgery, and are instructed not to remove the immobilization for 2 weeks. After this period, the immobilization is removed and patients begin rehabilitation with physiotherapy. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Intra-articular distal radius fracture treated with volar locking plate fixation; * Fracture occurred within the prior 30 days; * Consent to participate in the study Exclusion Criteria: * Concomitant fracture of the ipsilateral upper limb * Previous lesion of the ipsilateral upper limb with functional deficit * Bilateral fracture * Concomitant neurologic injury * Patient not amenable to follow-up
| Facility | City | Country | Status |
|---|---|---|---|
| Institute of Orthopedics and Traumatology - University of Sao Paulo | São Paulo, São Paulo | Brazil |