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

Not Applicable

Completed

• Conditions: Radius; Fracture, Lower or Distal End
• Interventions: Procedure: MIPO; Procedure: Conventional

• Registration Number: NCT06260761
• Lead Sponsor: Police General Hospital, Thailand

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

Study Timeline

• Study Start: 2021-10-05
• Primary Completion: 2023-02-05
• Study Completion: 2023-02-05
• Study First Submitted: 2024-01-25
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIPO	MIPO	isolated close fracture of distal end radius
Conventional	Conventional	isolated close fracture of distal end radius

Primary Outcome Measures

Name	Time	Method
Pain Visual analogue scale	Postoperative day 0-7 and 2,6,10,14,24 weeks	pain 0-10, minimum = 0 (best) , maximum = 10 (worst)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Police general hospital; 🇹🇭 Pathum Wan, Bangkok, Thailand