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

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

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

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Rheumatoid Arthritis, Knee; Spontaneous Osteonecrosis of Knee
• Intervention / Treatment: Procedure: Prepectoral; Procedure: Subpectoral

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 Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Woo Suk Lee; Phone Number: 82-2-2019-4601; Email: gsirb@yuhs.ac

Study Locations

• Korea, Republic of
  • GangnamGu
    • Seoul, GangnamGu, Korea, Republic of
      • Recruiting
      • Gangnam Severance Hospital
      • Contact: Soon-Phill Yoon; Phone Number: 82-2-2019-3410; Email: yspyonsei0212@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crepitus grade	Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus	3month, 6month, 1year after surgical treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Patellar displacement	Measuring patellar position in merchant view of plain radiograph.	3month, 6month, 1year after surgical treatment
Patellar tilt angle	Measuring patellar position in merchant view of plain radiograph.	3month, 6month, 1year after surgical treatment
Tibia offset	Estimate tibial component position in lateral plain radiograph.	3month, 6month, 1year after surgical treatment
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
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
Forgotten joint score	Clinical score evaluate functional outcome after surgery (0-100; low value represent better outcome)	3month, 6month, 1year after surgical treatment

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): October 6, 2025
• Study Completion (Estimated): October 6, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Osteoarthritis; Osteoarthritis, Knee; Osteonecrosis
• Other Study ID Numbers: 3-2023-0282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No