Skip to main content
OpenTrials
Completed

NCT Number: NCT06260761

MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radius; Fracture, Lower or Distal End Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Police general hospital

Pathum Wan, Bangkok, 10330, Thailand

About this study

Gap of knowledge

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIPO

Procedure

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

Conventional

Procedure

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

Primary outcomes

  1. 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

  1. 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)

  2. Grip strength

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

    compare with normal side 0-100%

  3. Pinch strength

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

    compare with normal side %

  4. Range of motion

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

    flexion extension pronation supination ulnar and radial deviation (degree)

  5. Aesthetics

    Time frame: Postoperative 24 weeks

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

  6. Satisfy

    Time frame: Postoperative 24 weeks

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

  7. Volar tile

    Time frame: Postoperative 2, 24 weeks

    radiographic parameter (degree)

  8. ulnar variance

    Time frame: Postoperative 2, 24 weeks

    radiographic parameter (centimeter)

  9. radial inclination

    Time frame: Postoperative 2, 24 weeks

    radiographic parameter (degree)

  10. operation time

    Time frame: Intraoperative

    (minute)

  11. skin incision

    Time frame: Postoperative 2 weeks

    (centimeter)

  12. morphine IV use

    Time frame: Postoperative day 0-2

    (milligram)

  13. complication

    Time frame: up to 24 weeks

    Number of Participants with complication and adverse event

Sponsors and collaborators

Lead sponsor

Police General Hospital, Thailand

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2024
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.