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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient and Observer Scar Assessment Scale Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will not be informed of their assigned intervention. The operating surgeon and surgical team cannot be masked because they perform the assigned procedure. Postoperative clinical and scar assessments will be conducted by an independent outcome assessor who was not involved in the surgery and is unaware of the treatment allocation. Because the interventions result in different incision and pin-site patterns, complete maintenance of participant masking cannot be guaranteed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MISI tenchique
Participants will undergo robotic-assisted total knee arthroplasty using the minimal incision and minimal soft-tissue injury (MISI) technique. The procedure uses an approximately 10-cm main incision with limited soft-tissue dissection. Two femoral tracking pins are inserted through the main incision, and one tibial tracking pin is inserted through an additional approximately 5-mm incision.
干预措施: MISI Robot-Assisted Total Knee Arthroplasty (Procedure)
Standard technique
Participants will undergo robotic-assisted total knee arthroplasty using the standard surgical technique. Tracking arrays are secured using the conventional pin placement method, with four tracking pins placed in the femoral and tibial regions and an additional femoral incision.
干预措施: Standard Robotic-Assisted Total Knee Arthroplasty (Procedure)
结局指标
主要结局
Patient and Observer Scar Assessment Scale Score
时间窗: 3 months after surgery
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.
次要结局
- Patient and Observer Scar Assessment Scale Score(3 and 6 weeks after surgery)
- Main Surgical Incision Length(During surgery and on postoperative day 1)
- Intraoperative Incision Stretching Index(During surgery)
- Postoperative Gauze Oozing Grade(Postoperative days 1, 2, 4, and 6)
- Thigh Pain at Rest on the Numeric Rating Scale(Postoperative days 1, 2, 4, and 6)
- Thigh Pain During Active Hip Flexion on the Numeric Rating Scale(Postoperative days 1, 2, 4, and 6)
- Tenderness at the Standardized Tracking Pin-Site Location(Postoperative days 1, 2, 4, and 6)
- Ability to Perform Straight-Leg Raising(Postoperative days 1, 2, 4, and 6)
- Pain During the Resisted Straight-Leg-Raising Test(Postoperative days 1, 2, 4, and 6)
- Incidence of Tracking Pin-Site Complications(Postoperative days 1, 2, 4, and 6 and postoperative week 3)
- Forgotten Joint Score-12(6 and 12 months after surgery)
- Western Ontario and McMaster Universities Osteoarthritis Index(6 and 12 months after surgery)
研究者
Jung-Il Kim
Associate Professor, Department of Orthopedic Surgery
Hallym University Kangnam Sacred Heart Hospital