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

NCT06260761 | Completed DMC

• 1 other identifier: Dh3108103/64
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Radius; Fracture, Lower or Distal End

Keywords

MIPO; distal end radius fracture; WALANT

Outcome Measures

Primary Outcomes (1)

• Pain Visual analogue scale

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

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

Secondary Outcomes (13)

• Quick Disabilities of the Arm, Shoulder and Hand

  Postoperative 2,6,10,14,24 weeks

• Grip strength

  Postoperative 2,6,10,14,24 weeks

• Pinch strength

  Postoperative 2,6,10,14,24 weeks

• Range of motion

  Postoperative 2,6,10,14,24 weeks

• Aesthetics

  Postoperative 24 weeks

Study Arms (2)

MIPO

EXPERIMENTAL

isolated close fracture of distal end radius

Procedure: MIPO

Conventional

ACTIVE COMPARATOR

isolated close fracture of distal end radius

Procedure: Conventional

Interventions

MIPO PROCEDURE

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

MIPO

Conventional PROCEDURE

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

Conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• isolated closed fractures of the distal end radius requiring surgery
• aged 18 years and older

You may not qualify if:

• 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

Sponsors & Collaborators

• Police General Hospital, Thailand: lead

Study Sites (1)

Police general hospital

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (4)

• Pire E, Hidalgo Diaz JJ, Salazar Botero S, Facca S, Liverneaux PA. Long Volar Plating for Metadiaphyseal Fractures of Distal Radius: Study Comparing Minimally Invasive Plate Osteosynthesis versus Conventional Approach. J Wrist Surg. 2017 Aug;6(3):227-234. doi: 10.1055/s-0037-1599791. Epub 2017 Mar 16.

  PMID: 28725505 RESULT

• Vernet P, Gouzou S, Hidalgo Diaz JJ, Facca S, Liverneaux P. Minimally invasive anterior plate osteosynthesis of the distal radius: A 710 case-series. Orthop Traumatol Surg Res. 2020 Dec;106(8):1619-1625. doi: 10.1016/j.otsr.2020.04.024. Epub 2020 Nov 3.

  PMID: 33153957 RESULT

• Zenke Y, Sakai A, Oshige T, Moritani S, Fuse Y, Maehara T, Nakamura T. Clinical results of volar locking plate for distal radius fractures: conventional versus minimally invasive plate osteosynthesis. J Orthop Trauma. 2011 Jul;25(7):425-31. doi: 10.1097/BOT.0b013e3182008c83.

  PMID: 21464735 RESULT

• Zhang X, Huang X, Shao X, Zhu H, Sun J, Wang X. A comparison of minimally invasive approach vs conventional approach for volar plating of distal radial fractures. Acta Orthop Traumatol Turc. 2017 Mar;51(2):110-117. doi: 10.1016/j.aott.2017.02.013. Epub 2017 Feb 27.

  PMID: 28246046 RESULT

MeSH Terms

Conditions

Fractures, Bone

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• suphasan keatisuwan, M.D.

  Police general hospital, Bangkok, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The data collector, an orthopedic resident unaware of the surgical technique used, obtained information after operation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 15, 2024
• Study Start: October 5, 2021
• Primary Completion: February 5, 2023
• Study Completion: February 5, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)