Minimal-Incision Technique With Modified Tracking Pin Placement Versus Standard Robotic-Assisted Total Knee Arthroplasty

NCT07765771 | Not Yet Recruiting

• 1 other identifier: HKS 2026-05-024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Robot-Assisted Total Knee Arthroplasty; Minimally Invasive Surgery; Minimal Incision; MISI

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after surgery

Secondary Outcomes (12)

• 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

Study Arms (2)

MISI tenchique

EXPERIMENTAL

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.

Procedure: MISI Robot-Assisted Total Knee Arthroplasty

Standard technique

ACTIVE COMPARATOR

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.

Procedure: Standard Robotic-Assisted Total Knee Arthroplasty

Interventions

MISI Robot-Assisted Total Knee Arthroplasty PROCEDURE

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.

MISI tenchique

Standard Robotic-Assisted Total Knee Arthroplasty PROCEDURE

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.

Standard technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Study Officials

• Joong-Il Kim, MD, PhD

  Hallym University Kangnam Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho-Jung Jung, MD, PhD

CONTACT

82-02-819-5165; hodge@hallym.or.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Orthopedic Surgery

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the MISI technique or the standard technique for robotic-assisted total knee arthroplasty.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)