Osteo Arthritis of the KneeMISINCT07765771
Minimal-Incision Technique With Modified Tracking Pin Placement Versus Standard Robotic-Assisted Total Knee Arthroplasty
A study testing MISI Robot-Assisted Total Knee Arthroplasty and Standard Robotic-Assisted Total Knee Arthroplasty in people with Osteo Arthritis of the Knee, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis of the Knee
- What is being tested?
- MISI Robot-Assisted Total Knee Arthroplasty and Standard Robotic-Assisted Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Aug 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Hallym University Kangnam Sacred Heart Hospital
Seoul
Ho-Jung Jung, MD, PhD, 82-02-819-5165, hodge@hallym.or.kr
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Osteo Arthritis of the Knee
- Being tested
- MISI Robot-Assisted Total Knee Arthroplasty, Standard Robotic-Assisted Total Knee Arthroplasty
- Keywords
- Robot-Assisted Total Knee Arthroplasty, Minimally Invasive Surgery, Minimal Incision, MISI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MISI Robot-Assisted Total Knee ArthroplastyProcedure or surgery
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.
Standard Robotic-Assisted Total Knee ArthroplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard Robotic-Assisted Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (12)
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.
Measured: 3 and 6 weeks after surgery
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.
Measured: During surgery and on postoperative day 1
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.
Measured: During surgery
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.
Measured: Postoperative days 1, 2, 4, and 6
Thigh Pain at Rest on the Numeric Rating Scale
Participants will rate thigh pain at rest using an 11-point numeric rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Postoperative days 1, 2, 4, and 6
Thigh Pain During Active Hip Flexion on the Numeric Rating Scale
Participants will rate thigh pain during active hip flexion while maintaining knee extension and without external resistance. Pain will be assessed using an 11-point numeric rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Postoperative days 1, 2, 4, and 6
Tenderness at the Standardized Tracking Pin-Site Location
Tenderness elicited by palpation at a prespecified standardized anatomical location corresponding to the tracking pin region will be rated using an 11-point numeric rating scale ranging from 0 to 10, where 0 indicates no tenderness and 10 indicates the worst imaginable tenderness.
Measured: Postoperative days 1, 2, 4, and 6
Ability to Perform Straight-Leg Raising
The participant's ability to independently raise the operated lower extremity while maintaining knee extension will be recorded as a binary outcome: able or unable to perform straight-leg raising. The number and proportion of participants able to perform the test will be compared between groups.
Measured: Postoperative days 1, 2, 4, and 6
Pain During the Resisted Straight-Leg-Raising Test
Pain during resisted straight-leg raising will be assessed using a 100-mm visual analog scale, where 0 mm indicates no pain and 100 mm indicates the worst imaginable pain.
Measured: Postoperative days 1, 2, 4, and 6
Incidence of Tracking Pin-Site Complications
Tracking pin sites will be examined for complications, including erythema, swelling, wound drainage, infection, and pin-related fracture. The occurrence of one or more prespecified pin-site complications will be recorded as a binary outcome, and the number and proportion of participants with any complication will be reported.
Measured: Postoperative days 1, 2, 4, and 6 and postoperative week 3
Forgotten Joint Score-12
The Forgotten Joint Score-12 is a 12-item patient-reported questionnaire assessing awareness of the operated knee during daily activities. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating less awareness of the artificial joint and a better outcome.
Measured: 6 and 12 months after surgery
Western Ontario and McMaster Universities Osteoarthritis Index
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assesses knee pain, stiffness, and physical function. The 24 items are scored using a 5-point Likert scale, producing a total score ranging from 0 to 96. Higher scores indicate more severe symptoms and poorer physical function.
Measured: 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start17 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Il Kim, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- Joong-Il Kim, MD, PhD, Principal investigator, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765771
- Sponsor's protocol ID
- HKS 2026-05-024
- Acronym
- MISI
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07765771
- Acronym / sponsor ID
- MISI / HKS 2026-05-024
- Conditions
- Osteo Arthritis of the Knee
- Keywords
- Robot-Assisted Total Knee Arthroplasty, Minimally Invasive Surgery, Minimal Incision, MISI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MISI tenchique | Experimental | Procedure: MISI Robot-Assisted Total Knee ArthroplastyParticipants 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. |
| Standard technique | Active comparator | Procedure: Standard Robotic-Assisted Total Knee ArthroplastyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MISI Robot-Assisted Total Knee ArthroplastyRobot-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 or surgery | MISI tenchique |
| Standard Robotic-Assisted Total Knee ArthroplastyRobot-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. | Procedure or surgery | Standard technique |
Primary outcome
Patient and Observer Scar Assessment Scale Score
Time frame: 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.
12 secondary outcomes
Patient and Observer Scar Assessment Scale Score
Time frame: 3 and 6 weeks after surgery
Main Surgical Incision Length
Time frame: During surgery and on postoperative day 1
Intraoperative Incision Stretching Index
Time frame: During surgery
Postoperative Gauze Oozing Grade
Time frame: Postoperative days 1, 2, 4, and 6
Thigh Pain at Rest on the Numeric Rating Scale
Time frame: Postoperative days 1, 2, 4, and 6
Thigh Pain During Active Hip Flexion on the Numeric Rating Scale
Time frame: Postoperative days 1, 2, 4, and 6
Tenderness at the Standardized Tracking Pin-Site Location
Time frame: Postoperative days 1, 2, 4, and 6
Ability to Perform Straight-Leg Raising
Time frame: Postoperative days 1, 2, 4, and 6
Pain During the Resisted Straight-Leg-Raising Test
Time frame: Postoperative days 1, 2, 4, and 6
Incidence of Tracking Pin-Site Complications
Time frame: Postoperative days 1, 2, 4, and 6 and postoperative week 3
Forgotten Joint Score-12
Time frame: 6 and 12 months after surgery
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 6 and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joong-Il Kim, MD, PhD principal investigator
Hallym University Kangnam Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MISI Robot-Assisted Total Knee Arthroplasty and Standard Robotic-Assisted Total Knee Arthroplasty in people with Osteo Arthritis of the Knee, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ho-Jung Jung, MD, PhD (82-02-819-5165, hodge@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale Score (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.