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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-17

Study Completion Date

2023-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis (OA) of the Knee OA Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1

Group Type ACTIVE_COMPARATOR

Anatomical size patella component

Intervention Type PROCEDURE

After the patella was resurfaced, surgeon evaluated the symmetry through haptic feedback and assessed the thickness by measuring the distance from the anterior to posterior center of the patella. An inset, single pegged patella component was cemented after milling the patella. The patella was medialized as the patella bone would allow. Synovium laying on top of the femoral component with the knee in extension was routinely excised. Lateral facetectomy and restoration of native patella thickness were performed in all knees. In the control group, anatomically sized patella components were used.

Group 2

Group Type ACTIVE_COMPARATOR

Reduced size patella component

Intervention Type PROCEDURE

The same procedure of patella resurfacing as control group was done, then 3 mm reduced size patella component was used in the intervention group.

Interventions

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Anatomical size patella component

After the patella was resurfaced, surgeon evaluated the symmetry through haptic feedback and assessed the thickness by measuring the distance from the anterior to posterior center of the patella. An inset, single pegged patella component was cemented after milling the patella. The patella was medialized as the patella bone would allow. Synovium laying on top of the femoral component with the knee in extension was routinely excised. Lateral facetectomy and restoration of native patella thickness were performed in all knees. In the control group, anatomically sized patella components were used.

Intervention Type PROCEDURE

Reduced size patella component

The same procedure of patella resurfacing as control group was done, then 3 mm reduced size patella component was used in the intervention group.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No