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

Police General Hospital, Thailand68 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Radius; Fracture, Lower or Distal End

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain Visual analogue scale

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

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

Secondary Outcomes

Quick Disabilities of the Arm, Shoulder and Hand

functional score 0-100 , minimum = 0 (best) , maximum = 100 (worst)

Time frame: Postoperative 2,6,10,14,24 weeks

Grip strength

compare with normal side 0-100%

Time frame: Postoperative 2,6,10,14,24 weeks

Pinch strength

compare with normal side %

Time frame: Postoperative 2,6,10,14,24 weeks

Range of motion

flexion extension pronation supination ulnar and radial deviation (degree)

Time frame: Postoperative 2,6,10,14,24 weeks

Aesthetics

range 0-5; 0=bad 3=so so 5=good

Time frame: Postoperative 24 weeks

Satisfy

range 0-5; 0=Unsatisfied 3=so so 5=Satisfy

Time frame: Postoperative 24 weeks

Volar tile

radiographic parameter (degree)

Time frame: Postoperative 2, 24 weeks

ulnar variance

radiographic parameter (centimeter)

Time frame: Postoperative 2, 24 weeks

radial inclination

radiographic parameter (degree)

Time frame: Postoperative 2, 24 weeks

operation time

(minute)

Time frame: Intraoperative

skin incision

(centimeter)

Time frame: Postoperative 2 weeks

morphine IV use

(milligram)

Time frame: Postoperative day 0-2

complication

Number of Participants with complication and adverse event

Time frame: up to 24 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes