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

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Posteriorly Stabilized (PS) Total Knee System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957021
• Other study ID #: 55
• Status: Completed
• Phase: N/A
• First received: August 10, 2009
• Last updated: April 30, 2015
• Start date: December 2005
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: January 2014
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• Triathlon® PS Total Knee System
Triathlon® PS Total Knee system

Locations

Country	Name	City	State
United States	New England Baptist Hospital	Boston	Massachusetts
United States	Pro-Sports Orthopaedics, Inc. / New England Baptist Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Wellington Orthopaedics & Sports Medicine	Cincinnati	Ohio
United States	Hughston Clinic PA	Columbus	Georgia
United States	Specialty Orthopaedics	Harrison	New York
United States	Kelsey-Seybold Clinic	Houston	Texas
United States	Ireland Hip and Knee Surgery	Indianapolis	Indiana
United States	New Hampshire Orthopaedic Surgery, PA	Manchester	New Hampshire
United States	Tri County Orthopedic Surgeons, Inc.	Massillon	Ohio
United States	St. Cloud Orthopaedic Associates	Sartell	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion	The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.	2 years	No
Secondary	Patient Outcome Knee Society Score	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.	1,2 and 5 years	No
Secondary	Patient Outcome SF-36	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.	1,2,3,4 and 5 years	No
Secondary	Patient Outcome WOMAC	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.	5 years	No
Secondary	Patient Outcome Lower-Extremity Activity Scale	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.	1,2,3,4 and 5 years	No
Secondary	Radiographic Outcome	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.	1,2 and 5 years	Yes