Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study

NCT ID: NCT00957723

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 419 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2017-09-26

Brief Summary

The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.

Detailed Description

The Triathlon® Cruciate Retaining (CR) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol). The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon Cruciate Retaining (CR) Total Knee System as compared to the historical control.

Conditions

Arthroplasty, Replacement, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triathlon® CR Total Knee System

Participants receive the Triathlon® CR Total Knee System

Group Type: OTHER

Triathlon® CR Total Knee System

Intervention Type: DEVICE

The purpose is to evaluate the Triathlon® CR Total Knee System.

Interventions

Triathlon® CR Total Knee System

The purpose is to evaluate the Triathlon® CR Total Knee System.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subject is a male or non-pregnant female between the ages of 21 and 80.

2. The subject requires a primary cemented total knee replacement.

3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).

4. The subject has intact collateral ligaments.

5. The subject has signed the IRB-approved, study specific Informed Patient Consent Form.

6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria

1. Patient has inflammatory arthritis.

2. The subject is morbidly obese, BMI > 40.

3. The subject has a history of total or unicompartmental reconstruction of the affected joint.

4. Patient has had a high tibial osteotomy or femoral osteotomy.

5. The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device).

6. The patient has a systemic or metabolic disorder leading to progressive bone deterioration.

7. The subject is immunologically suppressed, or receiving chronic steroids (> 30 days duration).

8. The subject's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prothesis.

9. The subject has had a knee fusion to the affected joint.

10. The subject has an active or suspected latent infection in or about the knee joint.

11. The subject is a prisoner.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Knute Buehler, MD

Role: PRINCIPAL_INVESTIGATOR

The Center: Orthopaedic & Neurosurgical Care & Research

Brian Covino, MD

Role: PRINCIPAL_INVESTIGATOR

Knoxville Orthopedic Clinic

Joseph Davies, MD

Role: PRINCIPAL_INVESTIGATOR

Aurora Advanced Healthcare

Kenneth Greene, MD

Role: STUDY_CHAIR

Crystal Clinic

Anthony Hedley, MD

Role: PRINCIPAL_INVESTIGATOR

Arizona Institute for Bone and Joint Disorders

Kirby Hitt, MD

Role: PRINCIPAL_INVESTIGATOR

Scott & White Memorial Hospital

Joseph McCarthy, MD

Role: PRINCIPAL_INVESTIGATOR

Newton-Wellesley Hospital

Jeffrey Nassif, MD

Role: PRINCIPAL_INVESTIGATOR

Physician's Clinic of Iowa, PC

Kenneth Krackow, MD

Role: PRINCIPAL_INVESTIGATOR

Buffalo General Hospital, Department of Orthopaedics

Sean Scully, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars Medical Center University of Miami

Carlton Savory, MD

Role: PRINCIPAL_INVESTIGATOR

Hughston Sports Medicine Center

Mathew Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

Buffalo General Hospital, Department of Orthopaedics

Locations

Arizona Institute for Bone and Joint Disorders

Phoenix, Arizona, United States

Cedars Medical Center University of Miami

Miami, Florida, United States

Hughston Sports Medicine Center

Columbus, Georgia, United States

Physician's Clinic of Iowa, Mercy Medical Center

Cedar Rapids, Iowa, United States

Newton Wellesley Hospital

Newton, Massachusetts, United States

Buffalo General Hospital, Department of Orthopaedics Kaleida Health

Buffalo, New York, United States

Crystal Clinic

Akron, Ohio, United States

The Center: Orthopaedic & Neurosurgical Care & Research

Bend, Oregon, United States

Knoxville Orthopaedic Clinic

Knoxville, Tennessee, United States

Scott & White Memorial Hospital

Temple, Texas, United States

Aurora Advanced Healthcare

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

56

Identifier Type: -

Identifier Source: org_study_id