Clinical Study of Patellar Resurfacing and Non-resurfacing in Total Knee Arthroplasty

NCT ID: NCT03600922

Last Updated: 2018-07-27

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2017-08-31

Brief Summary

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The literature regarding resurfacing of the patella in total knee arthroplasty has conflicting conclusions. This study assesses medium-term clinical results of total knee arthroplasties performed with and without the patellar resurfacing in patients undergoing single-staged bilateral total knee arthroplasty in a randomized controlled, clinical study at a minimum of 5 years follow-up.

Detailed Description

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Sixty-six patients (132 knees) underwent primary single-staged bilateral total knee arthroplasty for osteoarthritis. Patients were randomized to receive resurfacing or retention of the patella. All patients received the Scorpio NRG knee prosthesis. Evaluations were done preoperatively and yearly, up to a minimum of 5 years postoperatively. Knee Society Score and Feller Score outcomes were measured. Anterior knee pain, the clunk of patella, and patient satisfaction questionnaires were completed.

Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Group Type EXPERIMENTAL

the patella was resurfaced.

Intervention Type PROCEDURE

Patellar resurfacing was undertaken using a cemented, inset domed component in TKA.

Interventions

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the patella was resurfaced.

Patellar resurfacing was undertaken using a cemented, inset domed component in TKA.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* degenerative OA
* 50-75 years
* All patients with OA were bilateral knee OA

Exclusion Criteria

* previous patellectomy
* inflammatory arthritis
* patellar fracture
* patellar instability
* previous extensor mechanism procedures
* high tibial osteotomy,
* severe valgus or varus deformity (\> 20°), severe flexion contracture (\> 30°)
* previous unicondylar knee replacement
* a history of septic arthritis or osteomyelitis.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liaocheng People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Ha C, Wang B, Li W, Sun K, Wang D, Li Q. Resurfacing versus not-resurfacing the patella in one-stage bilateral total knee arthroplasty: a prospective randomized clinical trial. Int Orthop. 2019 Nov;43(11):2519-2527. doi: 10.1007/s00264-019-04361-7. Epub 2019 Jun 21.

Reference Type DERIVED
PMID: 31227852 (View on PubMed)

Other Identifiers

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LCHOSPITAL-123456

Identifier Type: -

Identifier Source: org_study_id

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