A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zimmer Biomet
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- American Knee Society Score
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
ROCC
Intervention: ROCC Knee (Device)
2
LCS
Intervention: LCS Knee (Device)
Outcomes
Primary Outcomes
American Knee Society Score
Time Frame: Preoperative, 8weeks, 1 year
Secondary Outcomes
- WOMAC(preoperative, 8 weeks, 1 year)
- VAS Pain(Preoperative, 4weeks, 8weeks, 3months, 1 year)