MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT

February 12, 2024 updated by: Suphasan Keatisuwan, Police General Hospital, Thailand

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gap of knowledge

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

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • Police General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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
  • wrist bone deformities
  • the use of anticoagulation drugs
  • uncooperative behavior
  • those refusing to participate in the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIPO
isolated close fracture of distal end radius
Procedure: MIPO
minimal invasive surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT
Active Comparator: Conventional
isolated close fracture of distal end radius
Procedure: Conventional
standard surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Postoperative day 0-7 and 2,6,10,14,24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick Disabilities of the Arm, Shoulder and Hand
Time Frame: Postoperative 2,6,10,14,24 weeks
functional score 0-100 , minimum = 0 (best) , maximum = 100 (worst)
Postoperative 2,6,10,14,24 weeks
Grip strength
Time Frame: Postoperative 2,6,10,14,24 weeks
compare with normal side 0-100%
Postoperative 2,6,10,14,24 weeks
Pinch strength
Time Frame: Postoperative 2,6,10,14,24 weeks
compare with normal side %
Postoperative 2,6,10,14,24 weeks
Range of motion
Time Frame: Postoperative 2,6,10,14,24 weeks
flexion extension pronation supination ulnar and radial deviation (degree)
Postoperative 2,6,10,14,24 weeks
Aesthetics
Time Frame: Postoperative 24 weeks
range 0-5; 0=bad 3=so so 5=good
Postoperative 24 weeks
Satisfy
Time Frame: Postoperative 24 weeks
range 0-5; 0=Unsatisfied 3=so so 5=Satisfy
Postoperative 24 weeks
Volar tile
Time Frame: Postoperative 2, 24 weeks
radiographic parameter (degree)
Postoperative 2, 24 weeks
ulnar variance
Time Frame: Postoperative 2, 24 weeks
radiographic parameter (centimeter)
Postoperative 2, 24 weeks
radial inclination
Time Frame: Postoperative 2, 24 weeks
radiographic parameter (degree)
Postoperative 2, 24 weeks
operation time
Time Frame: Intraoperative
(minute)
Intraoperative
skin incision
Time Frame: Postoperative 2 weeks
(centimeter)
Postoperative 2 weeks
morphine IV use
Time Frame: Postoperative day 0-2
(milligram)
Postoperative day 0-2
complication
Time Frame: up to 24 weeks
Number of Participants with complication and adverse event
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Police General Hospital, Thailand

Investigators

  • Principal Investigator: suphasan keatisuwan, M.D., Police general hospital, Bangkok, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Actual)

February 5, 2023

Study Completion (Actual)

February 5, 2023

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dh3108103/64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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