About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
MISI Robot-Assisted Total Knee Arthroplasty
Procedure/SurgeryRobot-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.
Standard Robotic-Assisted Total Knee Arthroplasty
Procedure/SurgeryRobot-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.
Treatment groups
Trial outcomes
Primary outcomes
Patient and Observer Scar Assessment Scale Score
The combined Patient and Observer Scar Assessment Scale (POSAS) score is calculated by summing the total Patient Scale score and the total Observer Scale score. Each scale consists of six items rated from 1 to 10, resulting in a score of 6 to 60 for each scale and a combined score ranging from 12 to 120. Higher scores indicate poorer scar quality. The Observer Scale will be completed by an independent outcome assessor blinded to treatment allocation.
Secondary outcomes
Patient and Observer Scar Assessment Scale Score
The combined Patient and Observer Scar Assessment Scale (POSAS) score is calculated by summing the total Patient Scale score and the total Observer Scale score. Each scale consists of six items rated from 1 to 10, resulting in a score of 6 to 60 for each scale and a combined score ranging from 12 to 120. Higher scores indicate poorer scar quality. The Observer Scale will be completed by an independent outcome assessor blinded to treatment allocation.
Main Surgical Incision Length
The length of the main surgical incision will be measured in centimeters. The initial incision length will be measured immediately after the skin incision with the knee in extension, and the final incision length will be measured before wound closure. The incision length will also be evaluated on postoperative day 1. Separate tracking pin-site incisions will not be included.
Intraoperative Incision Stretching Index
The incision stretching index is calculated as the maximum length of the main incision during knee flexion and maximal surgical retraction divided by the initial incision length measured with the knee in extension. A value of 1 indicates no stretching, and higher values indicate greater intraoperative stretching of the incision and surrounding soft tissue.
Postoperative Gauze Oozing Grade
Postoperative wound oozing will be assessed according to the amount of blood or exudate visible on the surgical dressing using a prespecified ordinal grading scale. Higher grades indicate more extensive wound oozing.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: