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Clinical Trials/NCT06260761
NCT06260761
Completed
Not Applicable

Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar Locking Plate for Close Fractures of Distal End Radius Under WALANT

Police General Hospital, Thailand1 site in 1 country68 target enrollmentOctober 5, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radius; Fracture, Lower or Distal End
Sponsor
Police General Hospital, Thailand
Enrollment
68
Locations
1
Primary Endpoint
Pain Visual analogue scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to compare the Minimally Invasive Plate Osteosynthesis (MIPO) approach with conventional methods in volar locking plate treatment for distal end radius fractures under the Wide Awake Local Anesthesia No Tourniquet (WALANT) technique. The main question it aims to answer is: Does the MIPO approach provide better pain control than the conventional approach of volar locking plate fixation in distal radius fractures under WALANT? Participants will be requested to record their pain on the Visual Analog Scale (VAS), assess their functional scores, and undergo postoperative radiographic evaluations. Researchers will compare the MIPO group and the conventional group to determine the postoperative pain VAS scores, shedding light on the comparative effectiveness of the two approaches.

Detailed Description

Gap of knowledge * No comparison of conventional Versus MIPO technique under WALANT * No result in acute post-operative pain

Registry
clinicaltrials.gov
Start Date
October 5, 2021
End Date
February 5, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Police General Hospital, Thailand
Responsible Party
Principal Investigator
Principal Investigator

Suphasan Keatisuwan

Principal Investigator

Police General Hospital, Thailand

Eligibility Criteria

Inclusion Criteria

  • isolated closed fractures of the distal end radius requiring surgery
  • aged 18 years and older

Exclusion Criteria

  • Patients with bone fractures lasting more than 21 days
  • open fractures
  • articular multi-fragmentary comminuted fractures of the distal radius
  • not suitable to undergo volar approach surgery
  • individuals with combined carpal fractures or dislocation
  • ulna fractures
  • associated injuries
  • a history of previous wrist surgery
  • diabetes mellitus
  • chronic wrist inflammation

Outcomes

Primary Outcomes

Pain Visual analogue scale

Time Frame: Postoperative day 0-7 and 2,6,10,14,24 weeks

pain 0-10, minimum = 0 (best) , maximum = 10 (worst)

Secondary Outcomes

  • Satisfy(Postoperative 24 weeks)
  • skin incision(Postoperative 2 weeks)
  • Grip strength(Postoperative 2,6,10,14,24 weeks)
  • Pinch strength(Postoperative 2,6,10,14,24 weeks)
  • Range of motion(Postoperative 2,6,10,14,24 weeks)
  • ulnar variance(Postoperative 2, 24 weeks)
  • operation time(Intraoperative)
  • Quick Disabilities of the Arm, Shoulder and Hand(Postoperative 2,6,10,14,24 weeks)
  • Aesthetics(Postoperative 24 weeks)
  • Volar tile(Postoperative 2, 24 weeks)
  • radial inclination(Postoperative 2, 24 weeks)
  • morphine IV use(Postoperative day 0-2)
  • complication(up to 24 weeks)

Study Sites (1)

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