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

Radius; Fracture, Lower or Distal End Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06260761
• Other study ID #: Dh3108103/64
• Status: Completed
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: February 5, 2023

Study information

• Verified date: February 2024
• Source: Police General Hospital, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 5, 2023
• Est. primary completion date: February 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fractures
• Radius; Fracture, Lower or Distal End

Intervention

Procedure:
• MIPO
minimal invasive surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT
• Conventional
standard surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT

Locations

Country	Name	City	State
Thailand	Police general hospital	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Police General Hospital, Thailand

Country where clinical trial is conducted

Thailand, 

References & 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. — View 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. — View 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/B — View 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 20 — View Citation

Outcome

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