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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
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 17, 2008
Last Updated
June 16, 2017
Sponsor
Zimmer Biomet
Collaborators
Biomet U.K. Ltd.
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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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