Patellar Resurfacing in Total Knee Arthroplasty

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553982
• Other study ID #: aue1
• Secondary ID: 40-07172b 1.2007
• Status: Completed
• Phase: N/A
• First received: November 2, 2007
• Last updated: April 14, 2016
• Start date: October 2007
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Procedure:
• Patellar component
Resurfacing with onlay technique
• No patellar component
Trimming of osteophytes when appropriate

Locations

Country	Name	City	State
Norway	Sykehuset Innlandet HF, Lillehammer	Lillehammer

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee injury and Osteoarthritis Outcome Score		3 years follow up	Yes
Secondary	Oxford score, Knee Society score, Stair climbing test, Pain (VAS), Patient satisfaction (VAS)		3 years follow up	Yes