Gangnam Severance Hospital
Seoul, GangnamGu, South Korea
Location status: Recruiting
NCT Number: NCT06129214
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
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
Seoul, GangnamGu, South Korea
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1.Patients who scheduled to perform both total knee arthroplasty(TKA) using posteiror crucitate sustain type (PS)
Exclusion criteria
Remove all visible synovium in suprapatellar area under distal quadriceps tendon. All other procedures (Total Knee arthroplasty) are same with no intervention arm.
No remove any synovium in suparapatellar area under distal quadriceps tendon. All other preocedures are same with experimental arm.
Time frame: 3month, 6month, 1year after surgical treatment
Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus
Time frame: 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.
Time frame: 3month, 6month, 1year after surgical treatment
Measured in true lateral position in 30' knee flextion, measureing patellar position in lateral plain radiograph of knee.
Time frame: 3month, 6month, 1year after surgical treatment
Measuring patellar position in merchant view of plain radiograph.
Time frame: 3month, 6month, 1year after surgical treatment
Measuring patellar position in merchant view of plain radiograph.
Time frame: 3month, 6month, 1year after surgical treatment
Estimate tibial component position in lateral plain radiograph.
Time frame: 3month, 6month, 1year after surgical treatment
Clinical score evaluate functional ability of patients after surgery (0-100; high value represent better outcome)
Time frame: 3month, 6month, 1year after surgical treatment
Clinical score evaluate pain, stiffness, function of knee after surgery (0-96; low value represent better outcome)
Time frame: 3month, 6month, 1year after surgical treatment
Clinical score evaluate functional outcome after surgery (0-100; low value represent better outcome)
Contact information is provided by the study sponsor or research team.
Gangnam Severance Hospital
Other
Partial Synovectomy in Articular Side of Quadriceps Tendon Reduces Crepitus After Posterior Stabilized Total Knee Arthroplasty : a Randomized, Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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