Patellar Resurfacing in Total Knee Arthroplasty

NCT ID: NCT00553982

Last Updated: 2016-04-15

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2015-12-31

Brief Summary

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Background:

The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The implantation of a patellar component adds to the operation time and the costs of the operation.There is a huge variation as to whether the patella is resurfaced or not during TKA. Meta-analysis of prospective, randomised trials might indicate that patellar resurfacing reduces the risk of reoperation and anterior knee pain, but drawing firm conclusions is not possible and additional, high quality randomised trials are required.

Purpose:

The aim of this study is to determine whether ther is a difference between the two groups in knee pain, functions, patient satisfaction and quality of life after TKA.

Detailed Description

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Conditions

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Osteoarthritis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Patellar resurfacing

Group Type EXPERIMENTAL

Patellar component

Intervention Type PROCEDURE

Resurfacing with onlay technique

2

Patellar retention

Group Type ACTIVE_COMPARATOR

No patellar component

Intervention Type PROCEDURE

Trimming of osteophytes when appropriate

Interventions

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Patellar component

Resurfacing with onlay technique

Intervention Type PROCEDURE

No patellar component

Trimming of osteophytes when appropriate

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients less than 85 years old with osteoarthritis scheduled for primary knee arthroplasty.

Exclusion Criteria

* Patients who are not able to cooperate
* Serious deformity (not suitable for a standard CR prosthesis)
* Patellar thickness less than 18 mm
* Prior operation involving the extensor mechanism
* Rheumatoid arthritis
* Severe medical disability limiting the ability to walk
* Revision surgery
* Knees with predominantly patellofemoral arthrosis
Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sykehuset Innlandet HF

OTHER

Sponsor Role lead

Responsible Party

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Eirik Aunan

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eirik Aunan, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Innlandet, Lillehammer

Locations

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Sykehuset Innlandet HF, Lillehammer

Lillehammer, , Norway

Site Status

Countries

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Norway

Other Identifiers

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40-07172b 1.2007.952 (REK)

Identifier Type: -

Identifier Source: secondary_id

13-2007 SI (Personvernombudet)

Identifier Type: -

Identifier Source: secondary_id

aue1

Identifier Type: -

Identifier Source: org_study_id

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