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

Y

Yonsei University Health System (YUHS)

Status

Enrolling

Conditions

Spontaneous Osteonecrosis of Knee
Rheumatoid Arthritis, Knee
Osteoarthritis, Knee

Treatments

Procedure: Subpectoral
Procedure: Prepectoral

Study type

Interventional

Funder types

Other

Identifiers

NCT06129214
3-2023-0282

Details and patient eligibility

About

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

Full 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

Enrollment

78 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

78 participants in 2 patient groups

Synovium removal group
Experimental group
Treatment:
Procedure: Subpectoral
Procedure: Prepectoral
Synovium sustain group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Woo Suk Lee

Data sourced from clinicaltrials.gov

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