Functional outcomes after prophylactic endoscopic carpal tunnel release during volar locking plate fixation of distal radius fracture: a randomized controlled trial

Phase 4

• Conditions: Distal radius fracture, endoscopic carpal tunnel release, functional outcome, carpal tunnel syndrome; Operative distal radius fracture patients who have indication for volar locking plate fixation

• Registration Number: TCTR20221130001
• Lead Sponsor: Siriraj Research Development Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-30
• Study Completion: 2023-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Distal radius fracture patients who undergo volar locking plate fixation
2. Aged equal or more than 18 years old

Exclusion Criteria

1. Patients with pre-existing carpal tunnel syndrome
2. Previous carpal tunnel release on the same side of injury
3. Multiple trauma
4. Pathological fracture such as bone tumor, infection
5. Known allergy to acetaminophen, NSAIDs and opioids
6. Unable to communicate or comply to the outcome measurements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-rated wrist evaluation (PRWE) 2 weeks, 6 weeks, 3 months, 6 months and 12 months Self-rated questionnaire

Secondary Outcome Measures

Name	Time	Method
Quick Disabilities of the arm, shoulder, and hand (QuickDASH) 2 weeks, 6 weeks, 3 months, 6 months and 12 months Self-rated questionnaire,Grip strength 2 weeks, 6 weeks, 3 months, 6 months and 12 months Jamar hand grip dynamometer (measured in kilogram),Pain score 2 weeks, 6 weeks, 3 months, 6 months and 12 months Numerical rating scale,Thai version Boston Questionnaire 2 weeks, 6 weeks, 3 months, 6 months and 12 months Self-rated questionnaire,EuroQol- 5 dimensions- 5 levels (EQ-5D-5L) 2 weeks, 6 weeks, 3 months, 6 months and 12 months Quality of life questionnaire,Wrist range of motion 2 weeks, 6 weeks, 3 months, 6 months and 12 months Goniometer,Fingertip to distal palmar crease distance 2 weeks, 6 weeks, 3 months, 6 months and 12 months Fingertip to distal palmar crease distance,Complications 2 weeks, 6 weeks, 3 months, 6 months and 12 months Surgical site infection, wound dehiscence, median nerve palsy, palmar cutaneous nerve palsy, complex regional pain syndrome