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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2023-02-05

Brief Summary

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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.

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Detailed Description

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Gap of knowledge

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

Conditions

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Radius; Fracture, Lower or Distal End

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The data collector, an orthopedic resident unaware of the surgical technique used, obtained information after operation.

Study Groups

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MIPO

isolated close fracture of distal end radius

Group Type EXPERIMENTAL

MIPO

Intervention Type PROCEDURE

minimal invasive surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT

Conventional

isolated close fracture of distal end radius

Group Type ACTIVE_COMPARATOR

Conventional

Intervention Type PROCEDURE

standard surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT

Interventions

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MIPO

minimal invasive surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT

Intervention Type PROCEDURE

Conventional

standard surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes