Status:

COMPLETED

A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs

Lead Sponsor:

Zimmer Biomet

Collaborating Sponsors:

Biomet U.K. Ltd.

Conditions:

Osteoarthritis

Eligibility:

All Genders

Up to 80 years

Phase:

NA

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 implant...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • Previous knee surgery (except arthroscopic/open menisectomy)
  • Patients with inflammatory arthritis
  • Patients with significant medical co-morbidity - ASA IV
  • Disorders causing abnormal gait or significant pain
  • Patients unable to consent
  • Severe visual impairment

Key Trial Info

Start Date :

April 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2011

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00755144

Start Date

April 1 2007

End Date

January 1 2011

Last Update

June 20 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Musgrave Park Hospital

Belfast, United Kingdom