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

• ClinicalTrials.gov Identifier: NCT00957021
• Recruitment Status: Completed
• First Posted: August 12, 2009
• Results First Posted: December 5, 2013
• Last Update Posted: January 25, 2017
• Sponsor: Stryker Orthopaedics
• Information provided by (Responsible Party): Stryker Orthopaedics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Arthroplasty, Replacement, Knee	Device: Triathlon® PS Total Knee System	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 409 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Posteriorly Stabilized (PS) Total Knee System
• Study Start Date: December 2005
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: January 2014

Arms and Interventions

Arm	Intervention/treatment
Triathlon® PS Total Knee System; Triathlon® PS Total Knee System	Device: Triathlon® PS Total Knee System; Triathlon® PS Total Knee system

Outcome Measures

Primary Outcome Measures :

1. Range of Motion [ Time Frame: 2 years ]
   The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.

Secondary Outcome Measures :

1. Patient Outcome Knee Society Score [ Time Frame: 1,2 and 5 years ]
   The Knee Society Scores (KSS) at 1, 2, and 5-year visits will be compared. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen at each time point. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
2. Patient Outcome SF-36 [ Time Frame: 1,2,3,4 and 5 years ]
   The SF-36 score at 1, 2, 3, 4 and 5-year visits will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The SF-36 includes a physical component and a mental component and is completed by the participant. Physical component and mental component scores were calculated on a scale ranging from 0 to 100. Low values represented a poor health state and high values represented a good health state.
3. Patient Outcome WOMAC [ Time Frame: 5 years ]

   The Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores at 1, 2, 3, 4 and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen for each time point. The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.

   Data for the WOMAC is only available at the 5 year interval due to typographical errors noted on earlier interval forms rendering them invalid for comparison.

4. Patient Outcome Lower-Extremity Activity Scale [ Time Frame: 1,2,3,4 and 5 years ]
   The Lower-Extremity Activity Scale (LEAS) score at 1, 2, 3, 4 and 5-year intervals will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. A level of 1 indicated that the subject was confined to bed all day while a level of 18 indicated that the subject was up and about at will inside and outside of the house, and also participated in vigorous physical activity, such as competitive level sports, on a daily basis.
5. Radiographic Outcome [ Time Frame: 1,2 and 5 years ]
   Radiographic success/failure at 1, 2, and 5-year visits will be assessed. Radiographic failure is defined as a score of 10 or greater according to the Knee Society Roentgenographic Scoring System, regardless of symptoms. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is also a failure regardless of score.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Georgia

Hughston Clinic PA

Columbus, Georgia, United States, 31908

United States, Indiana

Ireland Hip and Knee Surgery

Indianapolis, Indiana, United States, 46260

United States, Massachusetts

New England Baptist Hospital

Boston, Massachusetts, United States, 02120

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

Boston, Massachusetts, United States, 02445

United States, Minnesota

St. Cloud Orthopaedic Associates

Sartell, Minnesota, United States, 56377

United States, New Hampshire

New Hampshire Orthopaedic Surgery, PA

Manchester, New Hampshire, United States, 03103

United States, New York

Specialty Orthopaedics

Harrison, New York, United States, 10528

United States, Ohio

Wellington Orthopaedics & Sports Medicine

Cincinnati, Ohio, United States, 45255

Tri County Orthopedic Surgeons, Inc.

Massillon, Ohio, United States, 44646

United States, Texas

Kelsey-Seybold Clinic

Houston, Texas, United States, 77025

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903

Sponsors and Collaborators

Stryker Orthopaedics

Investigators

• Principal Investigator: Eric R Benson, MD; New Hampshire Orthopaedic Surgery, PA
• Principal Investigator: Daniel Moretta, DO; Tri County Orthopedics Surgeons, Inc.
• Principal Investigator: James Bono, MD; New England Baptist Hospital
• Principal Investigator: David W Edelstein, MD; Kelsey-Seybold Clinic
• Principal Investigator: Philip Ireland, MD; Ireland Hip and Knee Surgery
• Principal Investigator: Joseph P Nessler, MD; St. Cloud Orthopaedic Associates
• Principal Investigator: Quanjun Cui, MD; University of Virginia
• Principal Investigator: Arnold Scheller, MD; Pro-Sports Orthopaedics, Inc./ New England Baptist Hospital
• Principal Investigator: Joel Sorger, MD; Wellington Orthopaedics and Sports Medicine
• Principal Investigator: Suresh Nayak, MD; Wellington Orthopaedics and Sports Medicine
• Principal Investigator: John I Waldrop, MD; Hughston Clinic, PA
• Principal Investigator: James McGrory, MD; Hughston Clinic, PA
• Principal Investigator: Steven B Zelicof, MD, PhD; Specialty Orthopaedics

More Information

• Responsible Party: Stryker Orthopaedics
• ClinicalTrials.gov Identifier: NCT00957021
• Other Study ID Numbers: 55
• First Posted: August 12, 2009
• Results First Posted: December 5, 2013
• Last Update Posted: January 25, 2017
• Last Verified: November 2016

Keywords provided by Stryker Orthopaedics:

Knee