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

NCT ID: NCT00755144

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-01-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

ROCC

Group Type EXPERIMENTAL

ROCC Knee

Intervention Type DEVICE

Cementless total knee arthroplasty with ROCC Knee

2

LCS

Group Type ACTIVE_COMPARATOR

LCS Knee

Intervention Type DEVICE

Cementless total knee arthroplasty with LCS Knee

Interventions

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LCS Knee

Cementless total knee arthroplasty with LCS Knee

Intervention Type DEVICE

ROCC Knee

Cementless total knee arthroplasty with ROCC Knee

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomet U.K. Ltd.

INDUSTRY

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Musgrave Park Hospital

Belfast, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BMET UK 05

Identifier Type: -

Identifier Source: org_study_id

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