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Patellar Resurfacing in Total Knee Arthroplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eirik Aunan, Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00553982
First received: November 2, 2007
Last updated: January 1, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Sykehuset Innlandet HF:

Primary Outcome Measures:
  • Knee injury and Osteoarthritis Outcome Score [ Time Frame: 3 years follow up ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 110
Study Start Date: October 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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)
Study First Received: November 2, 2007
Last Updated: January 1, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Sykehuset Innlandet HF:
Replacement
Knee
Patella
Arthroplasty

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

ClinicalTrials.gov processed this record on June 17, 2013