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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

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

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Arm Type

Experimental

Arm Description

ROCC

Arm Title

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

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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