Overview

This trial is active, not recruiting.

Conditions osteoarthritis, pain
Treatments patellar component, no patellar component
Sponsor Sykehuset Innlandet HF
Start date October 2007
End date June 2015
Trial size 130 participants
Trial identifier NCT00553982, 13-2007 SI (Personvernombudet), 40-07172b 1.2007.952 (REK), aue1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Patellar resurfacing
patellar component
Resurfacing with onlay technique
(Active Comparator)
Patellar retention
no patellar component
Trimming of osteophytes when appropriate

Primary Outcomes

Measure
Knee injury and Osteoarthritis Outcome Score
time frame: 3 years follow up

Secondary Outcomes

Measure
Oxford score, Knee Society score, Stair climbing test, Pain (VAS), Patient satisfaction (VAS)
time frame: 3 years follow up

Eligibility Criteria

Male or female participants up to 85 years old.

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

Additional Information

Official title Patellar Resurfacing in Total Knee Arthroplasty. A Prospective, Randomised and Double Blind Study.
Principal investigator Eirik Aunan, Doctor
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Sykehuset Innlandet HF.