Clinical trial NCT06129214: Partial Synovectomy in Articular Side of Quadriceps Tendon Verified to Reduce Crepitus in Retrospective Study
Official title: Partial Synovectomy in Articular Side of Quadriceps Tendon Reduces Crepitus After Posterior Stabilized Total Knee Arthroplasty : a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Rheumatoid Arthritis, Knee
Spontaneous Osteonecrosis of Knee
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Crepitus grade
timeFrame: 3month, 6month, 1year after surgical treatment
Secondary outcomes:
measure: Hip knee ankle angle
timeFrame: 3month, 6month, 1year after surgical treatment
measure: Insall-Salvati ratio
timeFrame: 3month, 6month, 1year after surgical treatment
measure: Patellar displacement
timeFrame: 3month, 6month, 1year after surgical treatment
measure: Patellar tilt angle
timeFrame: 3month, 6month, 1year after surgical treatment
measure: Tibia offset
timeFrame: 3month, 6month, 1year after surgical treatment
measure: Knee society score
timeFrame: 3month, 6month, 1year after surgical treatment
measure: WOMAC score
timeFrame: 3month, 6month, 1year after surgical treatment
measure: Forgotten joint score
timeFrame: 3month, 6month, 1year after surgical treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
state: GangnamGu
Study officials:
References:
citation: 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.