ClinicalTrials.gg
RecruitingNCT06129214Updated Feb 21, 2025

Partial Synovectomy in Articular Side of Quadriceps Tendon Verified to Reduce Crepitus in Retrospective Study

An interventional study of Prepectoral and Subpectoral in Osteoarthritis, Knee, Rheumatoid Arthritis, Knee and Spontaneous Osteonecrosis of Knee, sponsored by Gangnam Severance Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.

Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of — 13 open to participants now, 21 under way, 4 of them phase 3. Osteoarthritis, Knee · Korea, Republic of.

Planned enrollment
60th of 85
78 · median 124
Started
2023
with 4 others
No phase
26 of 96
6 open now
Primary completion
2025-10
later than 5 of 20 live
Registered
77th of 96
by date
Lead sponsor
3 of 96
Gangnam Severance Hospital

Among the 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of, this one is the 60th largest by planned enrollment of the 85 interventional ones that give a count, is one of 5 that started in 2023, is one of 26 with no phase, reaches primary completion later than 5 of the 20 other live ones, and was the 77th registered.

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.

Browse Osteoarthritis, Knee studies →

Open to participants now

13 of the 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of, or all of them as a file.
02

Study 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. 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

03

Conditions studied

  • Osteoarthritis, Knee
  • Rheumatoid Arthritis, Knee
  • Spontaneous Osteonecrosis of Knee
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1.Patients who scheduled to perform both total knee arthroplasty(TKA) using posteiror crucitate sustain type (PS)

Exclusion criteria

Exclusion Criteria:

  1. Lost follow up (Including death of patient)
  2. Unexpected complication (e.g) Infection, periprosthetic fracture)
  3. Patella resurfacing
  4. Canceled surgical treatment
  5. Refused to enrolled study
  6. Too much radiological or physicological variance shown between either knee
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    Synovium removal group

    Procedure: Prepectoral · Procedure: Subpectoral

  • No intervention
    Synovium sustain group

Interventions

  • ProcedurePrepectoral

    Remove all visible synovium in suprapatellar area under distal quadriceps tendon. All other procedures (Total Knee arthroplasty) are same with no intervention arm.

  • ProcedureSubpectoral

    No remove any synovium in suparapatellar area under distal quadriceps tendon. All other preocedures are same with experimental arm.

06

What researchers measure

Primary outcomes

  1. Crepitus grade

    Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus

    Time frame: 3month, 6month, 1year after surgical treatment

Secondary outcomes

  1. Hip knee ankle angle

    Identify postop alignment of lower extrimities, which is mechanical axis between femur and tibia in scanogram of low extremity.

    Time frame: 3month, 6month, 1year after surgical treatment

  2. Insall-Salvati ratio

    Measured in true lateral position in 30' knee flextion, measureing patellar position in lateral plain radiograph of knee.

    Time frame: 3month, 6month, 1year after surgical treatment

  3. Patellar displacement

    Measuring patellar position in merchant view of plain radiograph.

    Time frame: 3month, 6month, 1year after surgical treatment

  4. Patellar tilt angle

    Measuring patellar position in merchant view of plain radiograph.

    Time frame: 3month, 6month, 1year after surgical treatment

  5. Tibia offset

    Estimate tibial component position in lateral plain radiograph.

    Time frame: 3month, 6month, 1year after surgical treatment

  6. Knee society score

    Clinical score evaluate functional ability of patients after surgery (0-100; high value represent better outcome)

    Time frame: 3month, 6month, 1year after surgical treatment

  7. WOMAC score

    Clinical score evaluate pain, stiffness, function of knee after surgery (0-96; low value represent better outcome)

    Time frame: 3month, 6month, 1year after surgical treatment

  8. Forgotten joint score

    Clinical score evaluate functional outcome after surgery (0-100; low value represent better outcome)

    Time frame: 3month, 6month, 1year after surgical treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Oct 2025, 23 months after the start.

Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 23 months is above that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2023
First posted
Nov 13, 2023
StartActual
Oct 16, 2023
Primary completionEst.
Oct 6, 2025
CompletionEst.
Oct 6, 2025
Last update
Feb 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06129214
Responsible party
Woo Suk Lee (professor, Gangnam Severance Hospital) — Principal investigator
First posted
Nov 13, 2023
Start date
Oct 16, 2023
Primary completion
Oct 6, 2025 (estimated)
Completion
Oct 6, 2025 (estimated)
Last update
Feb 21, 2025

Study contacts

Woo Suk Lee
Contact
gsirb@yuhs.ac
82-2-2019-4601

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion