A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs

Sponsor

Zimmer Biomet (Industry)

Overall Status

Completed

CT.gov ID

NCT00755144

Collaborator

Biomet U.K. Ltd. (Industry)

200

Enrollment

Location

Arms

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Device: LCS Knee Device: ROCC Knee	N/A

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

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 ROCC	Device: ROCC Knee Cementless total knee arthroplasty with ROCC Knee
Active Comparator: 2 LCS	Device: LCS Knee Cementless total knee arthroplasty with LCS Knee

Arm

Intervention/Treatment

Experimental: 1

ROCC

Device: ROCC Knee

Cementless total knee arthroplasty with ROCC Knee

Active Comparator: 2

LCS

Device: LCS Knee

Cementless total knee arthroplasty with LCS Knee

Outcome Measures

Primary Outcome Measures

American Knee Society Score [Preoperative, 8weeks, 1 year]

Secondary Outcome Measures

WOMAC [preoperative, 8 weeks, 1 year]
VAS Pain [Preoperative, 4weeks, 8weeks, 3months, 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Musgrave Park Hospital	Belfast		United Kingdom

Sponsors and Collaborators

Zimmer Biomet
Biomet U.K. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zimmer Biomet

ClinicalTrials.gov Identifier:

NCT00755144

Other Study ID Numbers:

BMET UK 05

First Posted:

Sep 18, 2008

Last Update Posted:

Jun 20, 2017

Last Verified:

Jun 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Study Results

No Results Posted as of Jun 20, 2017