A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement

NCT ID: NCT00351793

Last Updated: 2022-11-09

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

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2021-07-31

Brief Summary

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The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Combined Deformity <30 degrees

Knee Implant

Intervention Type DEVICE

Total knee replacement with Genesis II posterior stabilized knee

Combined Deformity >30 degrees

Knee Implant

Intervention Type DEVICE

Total knee replacement with Genesis II posterior stabilized knee

Interventions

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Knee Implant

Total knee replacement with Genesis II posterior stabilized knee

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* A combined deformity of \<30 degrees = group 1
* A combined deformity of \>30 degrees = group 2
* Patient is willing to consent to participate in the study
* Patient is available for follow-up through at least 2 years but preferably 5 years
* Patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk
* Patients who are fluent in English and are able to understand their role in a clinical trial

Exclusion Criteria

* Active, local infection or systemic infection
* Fibromyalgia patients
* Patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role collaborator

Ross Leighton

OTHER

Sponsor Role lead

Responsible Party

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Ross Leighton

Orthopedic Surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ross K Leighton, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Capital Health, Canada

Locations

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QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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CDHA-RL-004

Identifier Type: -

Identifier Source: org_study_id

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