Comparison of a Minimal Incision and Minimal Soft-Tissue Injury (MISI) Technique Versus the Standard Technique in Robotic-Assisted Total Knee Arthroplasty: A Randomized Controlled Trial
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.
Robotic-assisted total knee arthroplasty requires surgical exposure and placement of tracking pins. Conventional techniques may involve a relatively long incision, broader soft-tissue dissection, and diaphyseal pin insertion. The MISI technique was developed to reduce surgical invasiveness through a shorter incision, limited soft-tissue dissection, and modified tracking pin placement that avoids diaphyseal pin insertion. Participants will be randomly assigned to the MISI or standard technique in a 1:1 ratio. Clinical evaluations will be performed during follow-up for up to 12 months. The study will assess whether the MISI technique improves scar-related outcomes and early recovery without increasing procedure-related complications.
Inclusion Criteria: * Adults aged 18 years or older * Degenerative knee osteoarthritis requiring robotic-assisted total knee arthroplasty * Body mass index below 30 kg/m² * Preoperative knee flexion of 90 degrees or greater * Ability to understand the study information and provide written informed consent
Exclusion Criteria: * Skin lesions or conditions that may adversely affect wound healing * Previous intra-articular surgery of the affected knee * Inflammatory arthritis, including rheumatoid arthritis * Severe hepatic or renal disease associated with poor general health * Comorbid conditions that may substantially affect mobility, including Parkinson disease, sequelae of poliomyelitis, or stroke * Inability or unwillingness to complete the required follow-up * Any medical or other condition that, in the investigator's judgment, makes participation inappropriate
[{"measure":"Patient and Observer Scar Assessment Scale Score","timeFrame":"3 months after surgery"}]