A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs

Zimmer Biomet1 site in 1 country200 target enrollmentApril 2007

ConditionsOsteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Zimmer Biomet
Enrollment: 200
Locations: 1
Primary Endpoint: American Knee Society Score
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs.

Detailed Description

This study compares two similar designs of cementless rotating bearing total condylar knee replacements. The study will be conducted at a single clinical unit with a senior orthopaedic surgeon implanting all devices.Their performances will be assessed by clinical scores and comprehensive function outcome documentation undertaken by qualified physiotherapists. The persons undertaking the assessments will be blinded to which implants the patients have.

Registry

clinicaltrials.gov

Start Date

April 2007

End Date

January 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients suitable for cementless knee replacement
•Patients skeletally mature and under 80 years of age at pre-operative clinic
•Patients presenting with osteoarthritis of the knee
•Patients must be ambulatory at time of pre-operative clinic
•Patients must be able to understand instructions and be will to return for follow-up