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CompletedNCT06260761Updated Feb 15, 2024

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

An interventional study of MIPO and Conventional in Radius; Fracture, Lower or Distal End, sponsored by Police General Hospital, Thailand. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-15.

Sponsored by Police General Hospital, Thailand · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Oct 2021, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Gap of knowledge

  • No comparison of conventional Versus MIPO technique under WALANT
  • No result in acute post-operative pain
02

Conditions studied

  • Radius; Fracture, Lower or Distal End

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Keywords

  • MIPO
  • distal end radius fracture
  • WALANT
03

In context

Fractures, Bone

723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.

This study's enrollment of 68 is below the median of 80 across 458 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Police General Hospital, Thailand is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    MIPO

    isolated close fracture of distal end radius

    Procedure: MIPO

  • Active comparator
    Conventional

    isolated close fracture of distal end radius

    Procedure: Conventional

Interventions

  • ProcedureMIPO

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

  • ProcedureConventional

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Grip strength

    compare with normal side 0-100%

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

  3. Pinch strength

    compare with normal side %

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

  4. Range of motion

    flexion extension pronation supination ulnar and radial deviation (degree)

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

  5. Aesthetics

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

    Time frame: Postoperative 24 weeks

  6. Satisfy

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

    Time frame: Postoperative 24 weeks

  7. Volar tile

    radiographic parameter (degree)

    Time frame: Postoperative 2, 24 weeks

  8. ulnar variance

    radiographic parameter (centimeter)

    Time frame: Postoperative 2, 24 weeks

  9. radial inclination

    radiographic parameter (degree)

    Time frame: Postoperative 2, 24 weeks

  10. operation time

    (minute)

    Time frame: Intraoperative

  11. skin incision

    (centimeter)

    Time frame: Postoperative 2 weeks

  12. morphine IV use

    (milligram)

    Time frame: Postoperative day 0-2

  13. complication

    Number of Participants with complication and adverse event

    Time frame: up to 24 weeks

07

Study locations

1 site
  • Police general hospital
    Pathum Wan, Bangkok 10330, Thailand
08

References and documents

Publications

  • 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. PubMed 28725505 ↗
  • 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. PubMed 33153957 ↗
  • 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. PubMed 21464735 ↗
  • 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. PubMed 28246046 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Feb 2023, 16 months.

Of 148 non-industry interventional studies with no phase under Fractures, Bone, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's 16 months is below that.

Counting every sponsor, half of 166 studies reached it within 29 months; a quarter within 12 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2024
First posted
Feb 15, 2024
StartActual
Oct 5, 2021
Primary completionActual
Feb 5, 2023
CompletionActual
Feb 5, 2023
Last update
Feb 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06260761
Lead sponsor
Police General Hospital, Thailand
Responsible party
Suphasan Keatisuwan (Principal Investigator, Police General Hospital, Thailand) — Principal investigator
First posted
Feb 15, 2024
Start date
Oct 5, 2021
Primary completion
Feb 5, 2023
Completion
Feb 5, 2023
Last update
Feb 15, 2024

Study contacts

suphasan keatisuwan, M.D.
principal investigator · Police general hospital, Bangkok, Thailand

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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