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

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee; Rheumatoid Arthritis, Knee; Spontaneous Osteonecrosis of Knee
• Interventions: Procedure: Prepectoral; Procedure: Subpectoral

• Registration Number: NCT06129214
• Lead Sponsor: Gangnam Severance Hospital

Brief 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

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 Timeline

• Study Start: 2023-10-16
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-10-06
• Study Completion: 2025-10-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synovium removal group	Subpectoral	-
Synovium removal group	Prepectoral	-

Primary Outcome Measures

Name	Time	Method
Crepitus grade	3month, 6month, 1year after surgical treatment	Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus

Secondary Outcome Measures

Name	Time	Method
Hip knee ankle angle	3month, 6month, 1year after surgical treatment	Identify postop alignment of lower extrimities, which is mechanical axis between femur and tibia in scanogram of low extremity.
Insall-Salvati ratio	3month, 6month, 1year after surgical treatment	Measured in true lateral position in 30' knee flextion, measureing patellar position in lateral plain radiograph of knee.
Patellar displacement	3month, 6month, 1year after surgical treatment	Measuring patellar position in merchant view of plain radiograph.
Patellar tilt angle	3month, 6month, 1year after surgical treatment	Measuring patellar position in merchant view of plain radiograph.
Tibia offset	3month, 6month, 1year after surgical treatment	Estimate tibial component position in lateral plain radiograph.
Knee society score	3month, 6month, 1year after surgical treatment	Clinical score evaluate functional ability of patients after surgery (0-100; high value represent better outcome)
WOMAC score	3month, 6month, 1year after surgical treatment	Clinical score evaluate pain, stiffness, function of knee after surgery (0-96; low value represent better outcome)
Forgotten joint score	3month, 6month, 1year after surgical treatment	Clinical score evaluate functional outcome after surgery (0-100; low value represent better outcome)

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, GangnamGu, Korea, Republic of