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

NCT00351793 | Completed

• 1 other identifier: CDHA-RL-004
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Effectiveness and Safety

  Will evaluate effectiveness and safety during a 5 year period via analysis of the Knee Society Score, revision status, and radiographic evaluation

  5 years

Secondary Outcomes (2)

• Knee Society Clinical Rating

  Pre-op, 6 months, 1 year, 2 years, 5 years

• Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)

  Pre-op, 6 months, 1 year, 2 years, 5 years

Study Arms (2)

Combined Deformity <30 degrees

Device: Knee Implant

Combined Deformity >30 degrees

Device: Knee Implant

Interventions

Knee Implant DEVICE

Total knee replacement with Genesis II posterior stabilized knee

Combined Deformity <30 degrees; Combined Deformity >30 degrees

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Total knee replacement candidates

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ross Leighton: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Knee Prosthesis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Joint Prosthesis; Prostheses and Implants; Equipment and Supplies

Study Officials

• Ross K Leighton, MD, FRCS(C)

  Capital Health, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 13, 2006
• Study Start: January 1, 2003
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

CA (1)