Patellar Resurfacing in Total Knee Arthroplasty

April 14, 2016 updated by: Eirik Aunan, Sykehuset Innlandet HF

Patellar Resurfacing in Total Knee Arthroplasty. A Prospective, Randomised and Double Blind Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Lillehammer, Norway, 2629
        • Sykehuset Innlandet HF, Lillehammer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 81 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patellar resurfacing
Procedure: Patellar component
Resurfacing with onlay technique
Active Comparator: 2
Patellar retention
Procedure: No patellar component
Trimming of osteophytes when appropriate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee injury and Osteoarthritis Outcome Score
Time Frame: 3 years follow up
3 years follow up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Innlandet HF

Investigators

  • Principal Investigator: Eirik Aunan, Doctor, Sykehuset Innlandet, Lillehammer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aue1
  • 40-07172b 1.2007.952 (REK)
  • 13-2007 SI (Personvernombudet)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe