A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: LCS Knee (Device); ROCC Knee (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc.
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.
Clinical Details
Official title: A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: American Knee Society Score
Secondary outcome: WOMACVAS Pain
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.
Eligibility
Minimum age: N/A.
Maximum age: 80 Years.
Gender(s): Both.
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
Exclusion Criteria:
- 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
Locations and Contacts
Musgrave Park Hospital, Belfast, United Kingdom; Recruiting
David Beverland, FRCS, Phone: 028 90902000
David Beverland, FRCS, Principal Investigator
Additional Information
Starting date: April 2007
Ending date: April 2015
Last updated: September 17, 2008
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