Osteoarthritis, Knee, Rheumatoid Arthritis, Knee, Spontaneous Osteonecrosis of Knee
Conditions
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
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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crepitus grade | 3month, 6month, 1year after surgical treatment | Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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) |
| Tibia offset | 3month, 6month, 1year after surgical treatment | Estimate tibial component position in lateral plain radiograph. |
Countries
South Korea
Contacts
Primary ContactWoo Suk Lee
Outcome results
None listed