Osteoarthritis, KneeNCT06129214
Partial Synovectomy in Articular Side of Quadriceps Tendon Verified to Reduce Crepitus in Retrospective Study
A study testing Prepectoral and Subpectoral in people with Osteoarthritis, Knee and Rheumatoid Arthritis, Knee, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Crepitus causing unsatisfied result to patients after posterior stabilized total knee arthroplasty. Recent retrospective study demonstrated removal of hyperplastic synovium in distal quadriceps caused reduce of crepitus. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Rheumatoid Arthritis, Knee, Spontaneous Osteonecrosis of Knee
- What is being tested?
- Prepectoral and Subpectoral
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2023to 6 Oct 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Patients who scheduled to perform both total knee arthroplasty(TKA) using posteiror crucitate sustain type (PS)
Who cannot join
- Lost follow up (Including death of patient)
- Unexpected complication (e.g) Infection, periprosthetic fracture)
- Patella resurfacing
- Canceled surgical treatment
- Refused to enrolled study
- Too much radiological or physicological variance shown between either knee
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, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul, GangnamGu
Soon-Phill Yoon, 82-2-2019-3410, yspyonsei0212@yuhs.ac
About this study
Official title: Partial Synovectomy in Articular Side of Quadriceps Tendon Reduces Crepitus After Posterior Stabilized Total Knee Arthroplasty : a Randomized, Controlled Trial
Crepitus causing unsatisfied result to patients after posterior stabilized total knee arthroplasty. Recent retrospective study demonstrated removal of hyperplastic synovium in distal quadriceps caused reduce of crepitus. However, this study has limitation of time gap exist between arms, different in observation time and bias caused by retrospective review. Thus aim of this study is that by randomized trial, verified hyperplastic synovium in distal quadriceps causing crepitus.
Target enrolled patients in this study are scheduled to perform both total knee arthroplasty. Experimental group is randomized side (right or left) of knee, and control group is other side of knee. Both arms decided by randomized number table. Crepitus measured after 3mo, 6mo, 1year after surgical treatment
Read the detailed description
Surgical treatment of TKA with synovium removal in distal quadriceps tendon performed classifed as experimental arm and TKA wiout synovium removal classified as control arm. Before surgical treatment, radiologic and physiological evaluation performed to check too much variance shown in either arm. Radiologic parameter include Hip knee ankle angle, Femoral tibial angle, Level of joint line, Insall-Salvati ratio, Posterior tibial slope, Posterior femoral condylar offset, Patellar thickness, Patellar tilt, Patellar displacement. During surgical treatment patella resurfacing in either group excluded this study. Indication of patella resufacing is ICRS grade IV in lateral surface of patella. After surgical procedure done check grade of crepitus (0-no crepitation, 1-fine crepitation, 2-coarse crepitation) with WOMAC, Knee Society Score, Eq-5D (European quality of life -5 Dimensions), Forgotten joint score after 3month, 6month and 1year after surgical procedure.
Other collecting variance Age, Gender, BMI, Range of motion of knee, Fmoeral/Tibial component size, PE thickness
- Being tested
- Prepectoral, Subpectoral
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrepectoralProcedure or surgery
Remove all visible synovium in suprapatellar area under distal quadriceps tendon. All other procedures (Total Knee arthroplasty) are same with no intervention arm.
SubpectoralProcedure or surgery
No remove any synovium in suparapatellar area under distal quadriceps tendon. All other preocedures are same with experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Synovium removal group | Experimental | Not described Receives: Procedure: Prepectoral; Procedure: Subpectoral |
| Synovium sustain group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crepitus grade
Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus
Measured: 3month, 6month, 1year after surgical treatment
Secondary outcomes (8)
Hip knee ankle angle
Identify postop alignment of lower extrimities, which is mechanical axis between femur and tibia in scanogram of low extremity.
Measured: 3month, 6month, 1year after surgical treatment
Insall-Salvati ratio
Measured in true lateral position in 30' knee flextion, measureing patellar position in lateral plain radiograph of knee.
Measured: 3month, 6month, 1year after surgical treatment
Patellar displacement
Measuring patellar position in merchant view of plain radiograph.
Measured: 3month, 6month, 1year after surgical treatment
Patellar tilt angle
Measuring patellar position in merchant view of plain radiograph.
Measured: 3month, 6month, 1year after surgical treatment
Tibia offset
Estimate tibial component position in lateral plain radiograph.
Measured: 3month, 6month, 1year after surgical treatment
Knee society score
Clinical score evaluate functional ability of patients after surgery (0-100; high value represent better outcome)
Measured: 3month, 6month, 1year after surgical treatment
WOMAC score
Clinical score evaluate pain, stiffness, function of knee after surgery (0-96; low value represent better outcome)
Measured: 3month, 6month, 1year after surgical treatment
Forgotten joint score
Clinical score evaluate functional outcome after surgery (0-100; low value represent better outcome)
Measured: 3month, 6month, 1year after surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start16 Oct 2023
- Primary completion6 Oct 2025 (estimated)
- Study completion6 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Suk Lee, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129214
- Sponsor's protocol ID
- 3-2023-0282
- Status last verified
- Feb 2025
- First submitted
- 18 Oct 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chumchuen S, Kanitnate S, Wattanasirisombat K, Tammachote N. Synovium removal from the articular side of the quadriceps tendon around the superior pole of patella reduces the crepitus after total knee arthroplasty. Int Orthop. 2022 Nov;46(11):2561-2567. doi: 10.1007/s00264-022-05539-2. Epub 2022 Aug 13.
PubMed 35962233
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Synovectomy in Articular Side of Quadriceps Tendon Reduces Crepitus After Posterior Stabilized Total Knee Arthroplasty : a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06129214
- Acronym / sponsor ID
- 3-2023-0282
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 6 Oct 2025 (estimated)
- Study completion
- 6 Oct 2025 (estimated)
- First posted
- 13 Nov 2023 (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.
Crepitus causing unsatisfied result to patients after posterior stabilized total knee arthroplasty. Recent retrospective study demonstrated removal of hyperplastic synovium in distal quadriceps caused reduce of crepitus. However, this study has limitation of time gap exist between arms, different in observation time and bias caused by retrospective review. Thus aim of this study is that by randomized trial, verified hyperplastic synovium in distal quadriceps causing crepitus.
Target enrolled patients in this study are scheduled to perform both total knee arthroplasty. Experimental group is randomized side (right or left) of knee, and control group is other side of knee. Both arms decided by randomized number table. Crepitus measured after 3mo, 6mo, 1year after surgical treatment
Detailed description
Surgical treatment of TKA with synovium removal in distal quadriceps tendon performed classifed as experimental arm and TKA wiout synovium removal classified as control arm. Before surgical treatment, radiologic and physiological evaluation performed to check too much variance shown in either arm. Radiologic parameter include Hip knee ankle angle, Femoral tibial angle, Level of joint line, Insall-Salvati ratio, Posterior tibial slope, Posterior femoral condylar offset, Patellar thickness, Patellar tilt, Patellar displacement. During surgical treatment patella resurfacing in either group excluded this study. Indication of patella resufacing is ICRS grade IV in lateral surface of patella. After surgical procedure done check grade of crepitus (0-no crepitation, 1-fine crepitation, 2-coarse crepitation) with WOMAC, Knee Society Score, Eq-5D (European quality of life -5 Dimensions), Forgotten joint score after 3month, 6month and 1year after surgical procedure.
Other collecting variance Age, Gender, BMI, Range of motion of knee, Fmoeral/Tibial component size, PE thickness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synovium removal group | Experimental | Procedure: Prepectoral, Procedure: Subpectoral |
| Synovium sustain group | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Patients who scheduled to perform both total knee arthroplasty(TKA) using posteiror crucitate sustain type (PS)
Key exclusion criteria (6 listed)
- Lost follow up (Including death of patient)
- Unexpected complication (e.g) Infection, periprosthetic fracture)
- Patella resurfacing
- Canceled surgical treatment
- Refused to enrolled study
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 |
|---|---|---|
| PrepectoralRemove all visible synovium in suprapatellar area under distal quadriceps tendon. All other procedures (Total Knee arthroplasty) are same with no intervention arm. | Procedure or surgery | Synovium removal group |
| SubpectoralNo remove any synovium in suparapatellar area under distal quadriceps tendon. All other preocedures are same with experimental arm. | Procedure or surgery | Synovium removal group |
Primary outcome
Crepitus grade
Time frame: 3month, 6month, 1year after surgical treatment
Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus
8 secondary outcomes
Hip knee ankle angle
Time frame: 3month, 6month, 1year after surgical treatment
Insall-Salvati ratio
Time frame: 3month, 6month, 1year after surgical treatment
Patellar displacement
Time frame: 3month, 6month, 1year after surgical treatment
Patellar tilt angle
Time frame: 3month, 6month, 1year after surgical treatment
Tibia offset
Time frame: 3month, 6month, 1year after surgical treatment
Knee society score
Time frame: 3month, 6month, 1year after surgical treatment
WOMAC score
Time frame: 3month, 6month, 1year after surgical treatment
Forgotten joint score
Time frame: 3month, 6month, 1year after surgical treatment
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 21 Feb 2025.
- Results publication: PubMed 35962233Chumchuen S, Kanitnate S, Wattanasirisombat K, Tammachote N. Synovium removal from the articular side of the quadriceps tendon around the superior pole of patella reduces the crepitus after total knee arthroplasty. Int Orthop. 2022 Nov;46(11):2561-2567. doi: 10.1007/s00264-022-05539-2. Epub 2022 Aug 13.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prepectoral and Subpectoral in people with Osteoarthritis, Knee and Rheumatoid Arthritis, Knee, run by Gangnam Severance 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. 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 Woo Suk Lee (82-2-2019-4601, gsirb@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crepitus grade (time frame: 3month, 6month, 1year after surgical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06129214, which also lists 1 linked publication.
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 21 Feb 2025.