Clinical trial NCT06260761: MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT
Official title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar Locking Plate for Close Fractures of Distal End Radius Under WALANT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius; Fracture, Lower or Distal End
Keywords: MIPO
distal end radius fracture
WALANT
Lead sponsor: Police General Hospital, Thailand
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain Visual analogue scale
timeFrame: Postoperative day 0-7 and 2,6,10,14,24 weeks
Secondary outcomes:
measure: Quick Disabilities of the Arm, Shoulder and Hand
timeFrame: Postoperative 2,6,10,14,24 weeks
measure: Grip strength
timeFrame: Postoperative 2,6,10,14,24 weeks
measure: Pinch strength
timeFrame: Postoperative 2,6,10,14,24 weeks
measure: Range of motion
timeFrame: Postoperative 2,6,10,14,24 weeks
measure: Aesthetics
timeFrame: Postoperative 24 weeks
measure: Satisfy
timeFrame: Postoperative 24 weeks
measure: Volar tile
timeFrame: Postoperative 2, 24 weeks
measure: ulnar variance
timeFrame: Postoperative 2, 24 weeks
measure: radial inclination
timeFrame: Postoperative 2, 24 weeks
measure: operation time
timeFrame: Intraoperative
measure: skin incision
timeFrame: Postoperative 2 weeks
measure: morphine IV use
timeFrame: Postoperative day 0-2
measure: complication
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Police general hospital
state: Bangkok
Study officials:
affiliation: Police general hospital, Bangkok, Thailand
name: suphasan keatisuwan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.