Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study

NCT ID: NCT00957021

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 409 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2014-01-31

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® Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated using pre-operative scores and comparing them to post-operative scores in addition to being compared with cases who received the Scorpio® PS implant.

Detailed Description

The Triathlon® Posteriorly Stabilized (PS) 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® PS Total Knee System.

Conditions

Arthroplasty, Replacement, Knee

Study Design

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

Study Groups

Triathlon® PS Total Knee System

Triathlon® PS Total Knee System

Group Type: OTHER

Triathlon® PS Total Knee System

Intervention Type: DEVICE

Triathlon® PS Total Knee system

Interventions

Triathlon® PS Total Knee System

Triathlon® PS Total Knee system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subject is a male or non-pregnant female 21-80 years of age at the time of enrollment.

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. The subject 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. The subject has had a high tibial osteotomy or femoral osteotomy.

5. The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.

6. The subject 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 and cannot provide adequate support and/or fixation to the prosthesis.

9. The subject has had a knee fusion at 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

Eric R Benson, MD

Role: PRINCIPAL_INVESTIGATOR

New Hampshire Orthopaedic Surgery, PA

Daniel Moretta, DO

Role: PRINCIPAL_INVESTIGATOR

Tri County Orthopedics Surgeons, Inc.

James Bono, MD

Role: PRINCIPAL_INVESTIGATOR

New England Baptist Hospital

David W Edelstein, MD

Role: PRINCIPAL_INVESTIGATOR

Kelsey-Seybold Clinic

Philip Ireland, MD

Role: PRINCIPAL_INVESTIGATOR

Ireland Hip and Knee Surgery

Joseph P Nessler, MD

Role: PRINCIPAL_INVESTIGATOR

St. Cloud Orthopaedic Associates

Quanjun Cui, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Arnold Scheller, MD

Role: PRINCIPAL_INVESTIGATOR

Pro-Sports Orthopaedics, Inc./ New England Baptist Hospital

Joel Sorger, MD

Role: PRINCIPAL_INVESTIGATOR

Wellington Orthopaedics and Sports Medicine

Suresh Nayak, MD

Role: PRINCIPAL_INVESTIGATOR

Wellington Orthopaedics and Sports Medicine

John I Waldrop, MD

Role: PRINCIPAL_INVESTIGATOR

Hughston Clinic, PA

James McGrory, MD

Role: PRINCIPAL_INVESTIGATOR

Hughston Clinic, PA

Steven B Zelicof, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Specialty Orthopaedics

Locations

Hughston Clinic PA

Columbus, Georgia, United States

Ireland Hip and Knee Surgery

Indianapolis, Indiana, United States

New England Baptist Hospital

Boston, Massachusetts, United States

Pro-Sports Orthopaedics, Inc. / New England Baptist Hospital

Boston, Massachusetts, United States

St. Cloud Orthopaedic Associates

Sartell, Minnesota, United States

New Hampshire Orthopaedic Surgery, PA

Manchester, New Hampshire, United States

Specialty Orthopaedics

Harrison, New York, United States

Wellington Orthopaedics & Sports Medicine

Cincinnati, Ohio, United States

Tri County Orthopedic Surgeons, Inc.

Massillon, Ohio, United States

Kelsey-Seybold Clinic

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

55

Identifier Type: -

Identifier Source: org_study_id