Institute of Orthopedics and Traumatology - University of Sao Paulo
São Paulo, 05403010, Brazil
NCT Number: NCT03186963
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
São Paulo, 05403010, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional wrist dressing
Volar plaster splint
Time frame: 12 hours
Visual analogue scale for pain
Time frame: 18 hours
Visual analogue scale for pain
Time frame: 24 hours
Visual analogue scale for pain
Time frame: Once a day in the first week
Visual analogue scale for pain
Time frame: 2 weeks
Visual analogue scale for pain
Time frame: 6 weeks
Visual analogue scale for pain
Time frame: 3 months
Visual analogue scale for pain
Time frame: 6 months
Visual analogue scale for pain
Time frame: 6 weeks
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 3 months
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 6 months
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 2 weeks
Assessed by goniometry
Time frame: 6 weeks
Assessed by goniometry
Time frame: 3 months
Assessed by goniometry
Time frame: 6 months
Assessed by goniometry
Time frame: 2 weeks
Assessed by goniometry
Time frame: 6 weeks
Assessed by goniometry
Time frame: 3 months
Assessed by goniometry
Time frame: 6 months
Assessed by goniometry
Time frame: Once a day in the first week post-op
Percentage of patients requesting additional analgesia with tramadol in the first week
Time frame: up to 24 weeks
Percentage of patients presenting with any type of local orthopedic complication
University of Sao Paulo
Other
Effectiveness of Immobilization in the Postoperative Analgesia of Patients With Distal Radius Fracture Treated With Volar Locking Plating: a Prospective, Randomized Clinical Trial
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