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Recruiting NCT06129214

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

No phase Interventional Osteoarthritis, Knee Rheumatoid Arthritis, Knee Spontaneous Osteonecrosis of Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prepectoral, Subpectoral.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee, Rheumatoid Arthritis, Knee, Spontaneous Osteonecrosis of Knee. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Partial Synovectomy in Articular Side of Quadriceps Tendon Reduces Crepitus After Posterior Stabilized Total Knee Arthroplasty : a Randomized, Controlled Trial

Overview

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

  • 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.
  • Procedure Subpectoral
    No remove any synovium in suparapatellar area under distal quadriceps tendon. All other preocedures are same with experimental arm.

Primary outcome measures

  • Crepitus grade [Time frame: 3month, 6month, 1year after surgical treatment]
Secondary outcome measures (8)
  • Hip knee ankle angle [Time frame: 3month, 6month, 1year after surgical treatment]
  • Insall-Salvati ratio [Time frame: 3month, 6month, 1year after surgical treatment]
  • Patellar displacement [Time frame: 3month, 6month, 1year after surgical treatment]
  • Patellar tilt angle [Time frame: 3month, 6month, 1year after surgical treatment]
  • Tibia offset [Time frame: 3month, 6month, 1year after surgical treatment]
  • Knee society score [Time frame: 3month, 6month, 1year after surgical treatment]
  • WOMAC score [Time frame: 3month, 6month, 1year after surgical treatment]
  • Forgotten joint score [Time frame: 3month, 6month, 1year after surgical treatment]

Eligibility criteria

Inclusion criteria

1.Patients who scheduled to perform both total knee arthroplasty(TKA) using posteiror crucitate sustain type (PS)

Exclusion criteria

  • Lost follow up (Including death of patient)
  • Unexpected complication (e.g) Infection, periprosthetic fracture)
  • Patella resurfacing
  • Canceled surgical treatment
  • Refused to enrolled study
  • Too much radiological or physicological variance shown between either knee

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Gangnam Severance Hospital — Seoul

Publications

  • 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. PMID 35962233

Identifiers

NCT: NCT06129214 · 3-2023-0282

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗