Clinical trial NCT03186963: Effectiveness of Immobilization in the Postoperative Analgesia of Surgically Treated Distal Radius Fractures
Official title: Effectiveness of Immobilization in the Postoperative Analgesia of Patients With Distal Radius Fracture Treated With Volar Locking Plating: a Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fracture Distal
Keywords: distal radius fracture
volar plate
immobilization
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of pain
timeFrame: 12 hours
measure: Level of pain
timeFrame: 18 hours
measure: Level of pain
timeFrame: 24 hours
measure: Level of pain
timeFrame: Once a day in the first week
measure: Level of pain
timeFrame: 2 weeks
Secondary outcomes:
measure: Level of pain
timeFrame: 6 weeks
measure: Level of pain
timeFrame: 3 months
measure: Level of pain
timeFrame: 6 months
measure: DASH score
timeFrame: 6 weeks
measure: DASH score
timeFrame: 3 months
measure: DASH score
timeFrame: 6 months
measure: Wrist flexion-extension arc
timeFrame: 2 weeks
measure: Wrist flexion-extension arc
timeFrame: 6 weeks
measure: Wrist flexion-extension arc
timeFrame: 3 months
measure: Wrist flexion-extension arc
timeFrame: 6 months
measure: Forearm rotation arc
timeFrame: 2 weeks
measure: Forearm rotation arc
timeFrame: 6 weeks
measure: Forearm rotation arc
timeFrame: 3 months
measure: Forearm rotation arc
timeFrame: 6 months
measure: Tramadol use
timeFrame: Once a day in the first week post-op
measure: Complication
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Orthopedics and Traumatology - University of Sao Paulo
state: SP
Study officials:
affiliation: Institute of Orthopedics - University of Sao Paulo
name: Kodi E Kojima, MD
role: STUDY_CHAIR
References: