Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06129214
Other study ID # 3-2023-0282
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 16, 2023
Est. completion date October 6, 2025

Study information

Verified date January 2024
Source Gangnam Severance Hospital
Contact Woo Suk Lee
Phone 82-2-2019-4601
Email gsirb@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date October 6, 2025
Est. primary completion date October 6, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Prepectoral
Remove all visible synovium in suprapatellar area under distal quadriceps tendon. All other procedures (Total Knee arthroplasty) are same with no intervention arm.
Subpectoral
No remove any synovium in suparapatellar area under distal quadriceps tendon. All other preocedures are same with experimental arm.

Locations

Country Name City State
Korea, Republic of Gangnam Severance Hospital Seoul GangnamGu

Sponsors (1)

Lead Sponsor Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. d — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Crepitus grade Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus 3month, 6month, 1year after surgical treatment
Secondary Hip knee ankle angle Identify postop alignment of lower extrimities, which is mechanical axis between femur and tibia in scanogram of low extremity. 3month, 6month, 1year after surgical treatment
Secondary Insall-Salvati ratio Measured in true lateral position in 30' knee flextion, measureing patellar position in lateral plain radiograph of knee. 3month, 6month, 1year after surgical treatment
Secondary Patellar displacement Measuring patellar position in merchant view of plain radiograph. 3month, 6month, 1year after surgical treatment
Secondary Patellar tilt angle Measuring patellar position in merchant view of plain radiograph. 3month, 6month, 1year after surgical treatment
Secondary Tibia offset Estimate tibial component position in lateral plain radiograph. 3month, 6month, 1year after surgical treatment
Secondary Knee society score Clinical score evaluate functional ability of patients after surgery (0-100; high value represent better outcome) 3month, 6month, 1year after surgical treatment
Secondary WOMAC score Clinical score evaluate pain, stiffness, function of knee after surgery (0-96; low value represent better outcome) 3month, 6month, 1year after surgical treatment
Secondary Forgotten joint score Clinical score evaluate functional outcome after surgery (0-100; low value represent better outcome) 3month, 6month, 1year after surgical treatment
See also
  Status Clinical Trial Phase
Recruiting NCT03895489 - Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses N/A
Completed NCT03660943 - A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain Phase 3
Completed NCT04531969 - Comparison of Outpatient and Inpatient Spa Therapy N/A
Completed NCT02848027 - Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment Phase 3
Completed NCT05160246 - The Instant Effect of Kinesiology Taping in Patients With Knee OA N/A
Recruiting NCT06080763 - Biomechanics and Clinical Outcomes in Responders and Non-Responders
Completed NCT03643588 - The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain N/A
Active, not recruiting NCT05100225 - Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis Phase 2
Active, not recruiting NCT04061733 - New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis N/A
Completed NCT04051489 - A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
Recruiting NCT05546541 - Epidemiology and Nutrition
Recruiting NCT05447767 - Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg Phase 2
Not yet recruiting NCT04448106 - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis Phase 2
Not yet recruiting NCT03225911 - Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis N/A
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Completed NCT05703087 - Positive Cueing in Knee Arthroplasty. N/A
Not yet recruiting NCT06042426 - Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population Phase 4
Not yet recruiting NCT02865174 - Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty Phase 4
Terminated NCT02909257 - Motor-Sparing Femoral Nerve Block Dose Phase 4
Completed NCT02901964 - Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial N/A