Pain Clinical Trial
Official title:
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Sykehuset Innlandet HF, Lillehammer | Lillehammer |
Lead Sponsor | Collaborator |
---|---|
Sykehuset Innlandet HF |
Norway,
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 |
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