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

Osteoarthritis, Knee Clinical Trial

Official title:

Partial Synovectomy in Articular Side of Quadriceps Tendon Reduces Crepitus After Posterior Stabilized Total Knee Arthroplasty : a Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129214
• Other study ID #: 3-2023-0282
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: October 6, 2025

Study information

• Verified date: January 2024
• Source: Gangnam Severance Hospital
• Contact: Woo Suk Lee
• Phone: 82-2-2019-4601
• Email: gsirb[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: October 6, 2025
• Est. primary completion date: October 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Osteonecrosis

Intervention

Procedure:
• Prepectoral
Remove all visible synovium in suprapatellar area under distal quadriceps tendon. All other procedures (Total Knee arthroplasty) are same with no intervention arm.
• Subpectoral
No remove any synovium in suparapatellar area under distal quadriceps tendon. All other preocedures are same with experimental arm.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul	GangnamGu

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crepitus grade	Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus	3month, 6month, 1year after surgical treatment
Secondary	Hip knee ankle angle	Identify postop alignment of lower extrimities, which is mechanical axis between femur and tibia in scanogram of low extremity.	3month, 6month, 1year after surgical treatment
Secondary	Insall-Salvati ratio	Measured in true lateral position in 30' knee flextion, measureing patellar position in lateral plain radiograph of knee.	3month, 6month, 1year after surgical treatment
Secondary	Patellar displacement	Measuring patellar position in merchant view of plain radiograph.	3month, 6month, 1year after surgical treatment
Secondary	Patellar tilt angle	Measuring patellar position in merchant view of plain radiograph.	3month, 6month, 1year after surgical treatment
Secondary	Tibia offset	Estimate tibial component position in lateral plain radiograph.	3month, 6month, 1year after surgical treatment
Secondary	Knee society score	Clinical score evaluate functional ability of patients after surgery (0-100; high value represent better outcome)	3month, 6month, 1year after surgical treatment
Secondary	WOMAC score	Clinical score evaluate pain, stiffness, function of knee after surgery (0-96; low value represent better outcome)	3month, 6month, 1year after surgical treatment
Secondary	Forgotten joint score	Clinical score evaluate functional outcome after surgery (0-100; low value represent better outcome)	3month, 6month, 1year after surgical treatment