Radius; Fracture, Lower or Distal EndNCT06260761
MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT
A study testing MIPO and Conventional in people with Radius; Fracture, Lower or Distal End, run by Police General Hospital, Thailand at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radius; Fracture, Lower or Distal End
- What is being tested?
- MIPO and Conventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteThailand
- Study dates
- 5 Oct 2021to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- isolated closed fractures of the distal end radius requiring surgery
- aged 18 years and older
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Radius; Fracture, Lower or Distal End
- Being tested
- MIPO, Conventional
- Keywords
- MIPO, distal end radius fracture, WALANT
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIPOProcedure or surgery
minimal invasive surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT
ConventionalProcedure or surgery
standard surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT
| Study group | Role | What they receive |
|---|---|---|
| MIPO | Experimental | isolated close fracture of distal end radius Receives: Procedure: MIPO |
| Conventional | Active comparator | isolated close fracture of distal end radius Receives: Procedure: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual analogue scale
pain 0-10, minimum = 0 (best) , maximum = 10 (worst)
Measured: Postoperative day 0-7 and 2,6,10,14,24 weeks
Secondary outcomes (13)
Quick Disabilities of the Arm, Shoulder and Hand
functional score 0-100 , minimum = 0 (best) , maximum = 100 (worst)
Measured: Postoperative 2,6,10,14,24 weeks
Grip strength
compare with normal side 0-100%
Measured: Postoperative 2,6,10,14,24 weeks
Pinch strength
compare with normal side %
Measured: Postoperative 2,6,10,14,24 weeks
Range of motion
flexion extension pronation supination ulnar and radial deviation (degree)
Measured: Postoperative 2,6,10,14,24 weeks
Aesthetics
range 0-5; 0=bad 3=so so 5=good
Measured: Postoperative 24 weeks
Satisfy
range 0-5; 0=Unsatisfied 3=so so 5=Satisfy
Measured: Postoperative 24 weeks
Volar tile
radiographic parameter (degree)
Measured: Postoperative 2, 24 weeks
ulnar variance
radiographic parameter (centimeter)
Measured: Postoperative 2, 24 weeks
radial inclination
radiographic parameter (degree)
Measured: Postoperative 2, 24 weeks
operation time
(minute)
Measured: Intraoperative
skin incision
(centimeter)
Measured: Postoperative 2 weeks
morphine IV use
(milligram)
Measured: Postoperative day 0-2
complication
Number of Participants with complication and adverse event
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start5 Oct 2021
- Primary completion5 Feb 2023
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Radius; Fracture, Lower or Distal EndStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Police General Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suphasan Keatisuwan, Police General Hospital, Thailand
- Investigators
- suphasan keatisuwan, M.D., Principal investigator, Police general hospital, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260761
- Sponsor's protocol ID
- Dh3108103/64
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28725505Vernet 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 33153957Zenke 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 21464735Zhang 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 at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06260761
- Acronym / sponsor ID
- Dh3108103/64
- Conditions
- Radius; Fracture, Lower or Distal End
- Keywords
- MIPO, distal end radius fracture, WALANT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Police General Hospital, ThailandUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 5 Feb 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four.
| Arm | Type | Receives |
|---|---|---|
| MIPO | Experimental | Procedure: MIPOisolated close fracture of distal end radius |
| Conventional | Active comparator | Procedure: Conventionalisolated close fracture of distal end radius |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- isolated closed fractures of the distal end radius requiring surgery
- aged 18 years and older
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIPOminimal invasive surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT | Procedure or surgery | MIPO |
| Conventionalstandard surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT | Procedure or surgery | Conventional |
Primary outcome
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)
13 secondary outcomes
Quick Disabilities of the Arm, Shoulder and Hand
Time frame: Postoperative 2,6,10,14,24 weeks
Grip strength
Time frame: Postoperative 2,6,10,14,24 weeks
Pinch strength
Time frame: Postoperative 2,6,10,14,24 weeks
Range of motion
Time frame: Postoperative 2,6,10,14,24 weeks
Aesthetics
Time frame: Postoperative 24 weeks
Satisfy
Time frame: Postoperative 24 weeks
Volar tile
Time frame: Postoperative 2, 24 weeks
ulnar variance
Time frame: Postoperative 2, 24 weeks
radial inclination
Time frame: Postoperative 2, 24 weeks
operation time
Time frame: Intraoperative
skin incision
Time frame: Postoperative 2 weeks
morphine IV use
Time frame: Postoperative day 0-2
complication
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Results publication: PubMed 28725505Pire 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.
- Results publication: PubMed 33153957Vernet 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.
- Results publication: PubMed 21464735Zenke 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.
- Results publication: PubMed 28246046Zhang 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.
- Individual participant dataSharing planned: No
Related trials for Radius; Fracture, Lower or Distal End
Not yet recruiting
Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures
Distal Radius Fracture, Radius Fracture Distal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
suphasan keatisuwan, M.D. principal investigator
Police general hospital, Bangkok, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIPO and Conventional in people with Radius; Fracture, Lower or Distal End, run by Police General Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual analogue scale (time frame: Postoperative day 0-7 and 2,6,10,14,24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260761, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.