A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
LCS Knee
ROCC Knee
Sponsored by

About this trial
This is an interventional treatment trial for Osteoarthritis
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
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
Sites / Locations
- Musgrave Park Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
ROCC
LCS
Outcomes
Primary Outcome Measures
American Knee Society Score
Secondary Outcome Measures
WOMAC
VAS Pain
Full Information
NCT ID
NCT00755144
First Posted
September 17, 2008
Last Updated
June 16, 2017
Sponsor
Zimmer Biomet
Collaborators
Biomet U.K. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00755144
Brief Title
A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs
Official Title
A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
Collaborators
Biomet U.K. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ROCC
Arm Title
2
Arm Type
Active Comparator
Arm Description
LCS
Intervention Type
Device
Intervention Name(s)
LCS Knee
Intervention Description
Cementless total knee arthroplasty with LCS Knee
Intervention Type
Device
Intervention Name(s)
ROCC Knee
Intervention Description
Cementless total knee arthroplasty with ROCC Knee
Primary Outcome Measure Information:
Title
American Knee Society Score
Time Frame
Preoperative, 8weeks, 1 year
Secondary Outcome Measure Information:
Title
WOMAC
Time Frame
preoperative, 8 weeks, 1 year
Title
VAS Pain
Time Frame
Preoperative, 4weeks, 8weeks, 3months, 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
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
Facility Information:
Facility Name
Musgrave Park Hospital
City
Belfast
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs
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