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Patellar Resurfacing in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT00553982
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Eirik Aunan, Sykehuset Innlandet HF

Brief 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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Pain Procedure: Patellar component Procedure: No patellar component Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
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.
Study Start Date : October 2007
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

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


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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

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

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 Posted: November 6, 2007    Key Record Dates
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