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Effect of Different Size of Patellar Resurfacing on Patellar Crepitus of the One-stage Bilateral Total Knee Arthroplasty.

T

Thammasat University

Status

Completed

Conditions

OA Knee
Osteoarthritis (OA) of the Knee

Treatments

Procedure: Reduced size patella component
Procedure: Anatomical size patella component

Study type

Interventional

Funder types

Other

Identifiers

NCT06811506
Patella crep TUH

Details and patient eligibility

About

The goal of this study is to compare the incidence of patella crepitation using different size of patella component in bilateral simultaneously total knee arthroplasty with patella resurfacing. The main question is does size of patella component effect the incidence of patella crepitus? In the control group, anatomically sized patella components were used, whereas the intervention group received 3 mm smaller, reduced-size patella components. Participants were scheduled for follow up examination 2 weeks, 6 weeks, 6 months and 1 year for incidence of the patella crepitation and other outcomes.

Full description

For decades, total knee arthroplasty (TKA) has been the treatment of choice for knee osteoarthritis, with posterior-stabilized (PS) systems showing excellent long-term outcomes. However, patellar crepitus is more common with PS TKA systems because the cam and post mechanism can entrap fibrosynovial tissue within the intercondylar box, causing crepitus or clunking. Patellar crepitus (PC) was defined as an audible grinding noise or palpable vibrations in the knee during active and passive range of motion, detected by the examiner's hand on the patient's patella and sometimes can be audible.

This study was designed as a single-center, prospective randomized controlled trial comparing anatomical and reduced size of patella component in patients who underwent sequential bilateral TKA with patella resurfacing under single anesthesia. All participants were blinded to their intervention. A total of 94 knees from 47 patients were randomly assigned to undergo TKA with an anatomically sized patella component in one knee and reduced-size patella component in another knee or vice versa.

Crepitus, as a primary outcome, was assessed at 2, 6, 24 and 48 weeks follow-up using a validated and standardized approach. Crepitus was graded as: 0 (none), 1 (fine palpable), 2 (coarse palpable), and 3 (audible). Secondary outcomes included anterior knee pain (AKP), Feller's patella score (FPS), Kujala score, knee society score (KSS), range of motion (ROM), radiographic findings, and complications. AKP was measured using a 10-cm visual analog scale (VAS) in 1-cm increments. Knee ROM was measured with a goniometer. Radiographic parameters were measured at 6 months postoperatively.

Enrollment

94 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 50 and 80 years.
  • American Society of Anesthesiologists (ASA) Classification 1 or 2.
  • Diagnosed with primary knee osteoarthritis and requires bilateral total knee arthroplasty with patellar resurfacing.
  • Participants can understand and consent to participate in the research project

Exclusion criteria

  • Secondary knee osteoarthritis,
  • Previous knee surgery or arthroscopic surgery
  • Individuals who cannot undergo surgery due to underlying medical conditions.
  • BMI > 40 kg/m2
  • Infection around the knee

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

94 participants in 2 patient groups

Group 1
Active Comparator group
Treatment:
Procedure: Anatomical size patella component
Group 2
Active Comparator group
Treatment:
Procedure: Reduced size patella component

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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