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Patellar Resurfacing in Total Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00553982
First Posted: November 6, 2007
Last Update Posted: April 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eirik Aunan, Sykehuset Innlandet HF
  Purpose

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.


Condition Intervention
Osteoarthritis Pain Procedure: Patellar component Procedure: No patellar component

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patellar Resurfacing in Total Knee Arthroplasty. A Prospective, Randomised and Double Blind Study.

Resource links provided by NLM:


Further study details as provided by Eirik Aunan, Sykehuset Innlandet HF:

Primary Outcome Measures:
  • Knee injury and Osteoarthritis Outcome Score [ Time Frame: 3 years follow up ]

Secondary Outcome Measures:
  • Oxford score, Knee Society score, Stair climbing test, Pain (VAS), Patient satisfaction (VAS) [ Time Frame: 3 years follow up ]

Enrollment: 130
Study Start Date: October 2007
Study Completion Date: December 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553982


Locations
Norway
Sykehuset Innlandet HF, Lillehammer
Lillehammer, Norway, 2629
Sponsors and Collaborators
Sykehuset Innlandet HF
Investigators
Principal Investigator: Eirik Aunan, Doctor Sykehuset Innlandet, Lillehammer
  More Information

Responsible Party: Eirik Aunan, MD, Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT00553982     History of Changes
Other Study ID Numbers: aue1
40-07172b 1.2007.952 (REK)
13-2007 SI (Personvernombudet)
First Submitted: November 2, 2007
First Posted: November 6, 2007
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by Eirik Aunan, Sykehuset Innlandet HF:
Replacement
Knee
Patella
Arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases