Minimal-Incision Technique With Modified Tracking Pin Placement Versus Standard Robotic-Assisted Total Knee Arthroplasty
NCT07765771 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-08-14
Summary
This randomized controlled trial will compare a minimal-incision and soft-tissue-preserving (MISI) technique with the standard surgical technique in patients undergoing robotic-assisted total knee arthroplasty for knee osteoarthritis. A total of 100 participants will be randomly assigned in a 1:1 ratio to undergo either the MISI technique, which uses a reduced skin incision, limited soft-tissue dissection, and modified tracking pin placement, or the standard technique. The primary outcome is postoperative scar assessment at 3 months. Secondary outcomes include incision length, wound oozing, thigh pain and tenderness, recovery of straight-leg raising, tracking pin-related complications, patellar height, patient-reported scar assessments, and functional outcomes during follow-up.
Conditions
- Osteo Arthritis of the Knee
Interventions
- PROCEDURE
-
MISI Robot-Assisted Total Knee Arthroplasty
Robot-assisted total knee arthroplasty performed using an approximately 10-cm main incision, limited soft-tissue dissection, two femoral tracking pins inserted through the main incision, and one tibial tracking pin inserted through an additional approximately 5-mm incision.
- PROCEDURE
-
Standard Robotic-Assisted Total Knee Arthroplasty
Robot-assisted total knee arthroplasty performed using the standard incision and soft-tissue exposure, with conventional placement of four tracking pins in the femoral and tibial regions and an additional femoral incision.
Sponsors & Collaborators
-
Hallym University Kangnam Sacred Heart Hospital
lead OTHER
Principal Investigators
-
Joong-Il Kim, MD, PhD · Hallym University Kangnam Sacred Heart Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-17
- Primary Completion
- 2027-07-31
- Completion
- 2028-05-31
Countries
- South Korea
Study Locations
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