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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957021
First received: August 10, 2009
Last updated: April 30, 2015
Last verified: April 2015

August 10, 2009
April 30, 2015
December 2005
March 2011   (final data collection date for primary outcome measure)
Range of Motion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.
To compare the active range of motion values for subjects receiving the Triathlon PS Total Knee System with data from subjects who received the Scorpio PS implant in the Scorpio IDE study. [ Time Frame: at 2 years follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00957021 on ClinicalTrials.gov Archive Site
  • Patient Outcome Knee Society Score [ Time Frame: 1,2 and 5 years ] [ Designated as safety issue: No ]
    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.
  • Patient Outcome SF-36 [ Time Frame: 1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
    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.
  • Patient Outcome WOMAC [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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.

  • Patient Outcome Lower-Extremity Activity Scale [ Time Frame: 1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
    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.
  • Radiographic Outcome [ Time Frame: 1,2 and 5 years ] [ Designated as safety issue: Yes ]
    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.
To compare pain, function, radiographic outcomes, and health related quality of life with subjects' pre-operative status as well as with the control group (Scorpio PS), where available. [ Time Frame: at 2 years follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study
A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Posteriorly Stabilized (PS) Total Knee System

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Arthroplasty, Replacement, Knee
Device: Triathlon® PS Total Knee System
Triathlon® PS Total Knee system
Triathlon® PS Total Knee System
Triathlon® PS Total Knee System
Intervention: Device: Triathlon® PS Total Knee System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
409
January 2014
March 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00957021
55
No
Stryker Orthopaedics
Stryker Orthopaedics
Not Provided
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
Stryker Orthopaedics
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP