Radius; Fracture, Lower or Distal End
Conditions
Keywords
MIPO, distal end radius fracture, WALANT
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
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
Sponsors
Police General Hospital, Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The data collector, an orthopedic resident unaware of the surgical technique used, obtained information after operation.
Intervention model description
prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Visual analogue scale | Postoperative day 0-7 and 2,6,10,14,24 weeks | pain 0-10, minimum = 0 (best) , maximum = 10 (worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | Postoperative 2,6,10,14,24 weeks | compare with normal side 0-100% |
| Pinch strength | Postoperative 2,6,10,14,24 weeks | compare with normal side % |
| Range of motion | Postoperative 2,6,10,14,24 weeks | flexion extension pronation supination ulnar and radial deviation (degree) |
| Aesthetics | Postoperative 24 weeks | range 0-5; 0=bad 3=so so 5=good |
| Satisfy | Postoperative 24 weeks | range 0-5; 0=Unsatisfied 3=so so 5=Satisfy |
| Volar tile | Postoperative 2, 24 weeks | radiographic parameter (degree) |
| Quick Disabilities of the Arm, Shoulder and Hand | Postoperative 2,6,10,14,24 weeks | functional score 0-100 , minimum = 0 (best) , maximum = 100 (worst) |
| radial inclination | Postoperative 2, 24 weeks | radiographic parameter (degree) |
| operation time | Intraoperative | (minute) |
| skin incision | Postoperative 2 weeks | (centimeter) |
| morphine IV use | Postoperative day 0-2 | (milligram) |
| complication | up to 24 weeks | Number of Participants with complication and adverse event |
| ulnar variance | Postoperative 2, 24 weeks | radiographic parameter (centimeter) |
Countries
Thailand
Outcome results
None listed