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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIPO | Experimental | isolated close fracture of distal end radius |
|
| Conventional | Active Comparator | isolated close fracture of distal end radius |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIPO | Procedure | minimal invasive surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual analogue scale | pain 0-10, minimum = 0 (best) , maximum = 10 (worst) | Postoperative day 0-7 and 2,6,10,14,24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Grip strength | compare with normal side 0-100% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| suphasan keatisuwan, M.D. | Police general hospital, Bangkok, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Police general hospital | Pathum Wan | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28725505 | Result | 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. | |
| 33153957 | Result |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2021 | Feb 4, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2021 | Feb 4, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four.
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The data collector, an orthopedic resident unaware of the surgical technique used, obtained information after operation.
| Conventional | Procedure | standard surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT |
|
| Postoperative 2,6,10,14,24 weeks |
| Pinch strength | compare with normal side % | Postoperative 2,6,10,14,24 weeks |
| Range of motion | flexion extension pronation supination ulnar and radial deviation (degree) | Postoperative 2,6,10,14,24 weeks |
| Aesthetics | range 0-5; 0=bad 3=so so 5=good | Postoperative 24 weeks |
| Satisfy | range 0-5; 0=Unsatisfied 3=so so 5=Satisfy | Postoperative 24 weeks |
| Volar tile | radiographic parameter (degree) | Postoperative 2, 24 weeks |
| ulnar variance | radiographic parameter (centimeter) | Postoperative 2, 24 weeks |
| radial inclination | radiographic parameter (degree) | Postoperative 2, 24 weeks |
| operation time | (minute) | Intraoperative |
| skin incision | (centimeter) | Postoperative 2 weeks |
| morphine IV use | (milligram) | Postoperative day 0-2 |
| complication | Number of Participants with complication and adverse event | up to 24 weeks |
| 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. |
| 21464735 | 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. |
| 28246046 | 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. |