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
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No immobilization | Experimental | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No immobilization | Procedure | Conventional wrist dressing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Level of pain | Visual analogue scale for pain | 12 hours |
| Level of pain | Visual analogue scale for pain | 18 hours |
| Level of pain | Visual analogue scale for pain | 24 hours |
| Level of pain | Visual analogue scale for pain | Once a day in the first week |
| Level of pain | Visual analogue scale for pain | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Level of pain | Visual analogue scale for pain | 6 weeks |
| Level of pain | Visual analogue scale for pain | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kodi E Kojima, MD | Institute of Orthopedics - University of Sao Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Orthopedics and Traumatology - University of Sao Paulo | São Paulo | São Paulo | 05403010 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Volar splint |
| Procedure |
Volar plaster splint |
|
| Level of pain | Visual analogue scale for pain | 6 months |
| DASH score | Disabilities of the Arm, Shoulder and Hand (DASH) | 6 weeks |
| DASH score | Disabilities of the Arm, Shoulder and Hand (DASH) | 3 months |
| DASH score | Disabilities of the Arm, Shoulder and Hand (DASH) | 6 months |
| Wrist flexion-extension arc | Assessed by goniometry | 2 weeks |
| Wrist flexion-extension arc | Assessed by goniometry | 6 weeks |
| Wrist flexion-extension arc | Assessed by goniometry | 3 months |
| Wrist flexion-extension arc | Assessed by goniometry | 6 months |
| Forearm rotation arc | Assessed by goniometry | 2 weeks |
| Forearm rotation arc | Assessed by goniometry | 6 weeks |
| Forearm rotation arc | Assessed by goniometry | 3 months |
| Forearm rotation arc | Assessed by goniometry | 6 months |
| Tramadol use | Percentage of patients requesting additional analgesia with tramadol in the first week | Once a day in the first week post-op |
| Complication | Percentage of patients presenting with any type of local orthopedic complication | up to 24 weeks |