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

June 16, 2017 updated by: Zimmer Biomet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
American Knee Society Score
Time Frame: Preoperative, 8weeks, 1 year
Preoperative, 8weeks, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
WOMAC
Time Frame: preoperative, 8 weeks, 1 year
preoperative, 8 weeks, 1 year
VAS Pain
Time Frame: Preoperative, 4weeks, 8weeks, 3months, 1 year
Preoperative, 4weeks, 8weeks, 3months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Collaborators

Biomet U.K. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (ESTIMATE)

September 18, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 16, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMET UK 05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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