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

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06129214
Collaborator
(none)
78
2
22.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Prepectoral
  • Procedure: Subpectoral
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Partial Synovectomy in Articular Side of Quadriceps Tendon Reduces Crepitus After Posterior Stabilized Total Knee Arthroplasty : a Randomized, Controlled Trial
Anticipated Study Start Date :
Nov 30, 2023
Anticipated Primary Completion Date :
Oct 6, 2025
Anticipated Study Completion Date :
Oct 6, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Synovium removal group

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.

No Intervention: Synovium sustain group

Outcome Measures

Primary Outcome Measures

  1. Crepitus grade [3month, 6month, 1year after surgical treatment]

    Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. Patellar displacement [3month, 6month, 1year after surgical treatment]

    Measuring patellar position in merchant view of plain radiograph.

  4. Patellar tilt angle [3month, 6month, 1year after surgical treatment]

    Measuring patellar position in merchant view of plain radiograph.

  5. Tibia offset [3month, 6month, 1year after surgical treatment]

    Estimate tibial component position in lateral plain radiograph.

  6. 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)

  7. 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)

  8. Forgotten joint score [3month, 6month, 1year after surgical treatment]

    Clinical score evaluate functional outcome after surgery (0-100; low value represent better outcome)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Woo Suk Lee, professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT06129214
Other Study ID Numbers:
  • 3-2023-0282
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023