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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957723
First received: August 10, 2009
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Arthroplasty, Replacement, Knee
Device: Triathlon® CR Total Knee System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post-market, Non-randomized, Historical Controlled, Multi-center Study of the Outcomes of the Triathlon® Cruciate Retaining (CR) Total Knee System

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Active Range of Motion [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Patellar Subluxation, Dislocation and Fracture Rate [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Knee Society Score (KSS) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • SF-36 Health Survey [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster Osteoarthritis Index (WOMAC) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Lower-Extremity Activity Scale (LEAS) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Patient Outcome Long Term Follow-up Questionnaire [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Knee Society Total Knee Arthorplasty Roentgenographic Score [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Adverse Event Rate [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Enrollment: 419
Study Start Date: February 2005
Estimated Study Completion Date: January 2018
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Triathlon® CR Total Knee System
Participants receive the Triathlon® CR Total Knee System
Device: Triathlon® CR Total Knee System
The purpose is to evaluate the Triathlon® 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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957723

Locations
United States, Arizona
Arizona Institute for Bone and Joint Disorders
Phoenix, Arizona, United States, 85016
United States, Florida
Cedars Medical Center University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Hughston Sports Medicine Center
Columbus, Georgia, United States, 31908
United States, Iowa
Physician's Clinic of Iowa, Mercy Medical Center
Cedar Rapids, Iowa, United States, 52401
United States, Massachusetts
Newton Wellesley Hospital
Newton, Massachusetts, United States, 02462
United States, New York
Buffalo General Hospital, Department of Orthopaedics Kaleida Health
Buffalo, New York, United States, 14203
United States, Ohio
Crystal Clinic
Akron, Ohio, United States, 44330
United States, Oregon
The Center: Orthopaedic & Neurosurgical Care & Research
Bend, Oregon, United States, 97701
United States, Tennessee
Knoxville Orthopaedic Clinic
Knoxville, Tennessee, United States, 37909
United States, Texas
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
Aurora Advanced Healthcare
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Principal Investigator: Knute Buehler, MD The Center: Orthopaedic & Neurosurgical Care & Research
Principal Investigator: Brian Covino, MD Knoxville Orthopedic Clinic
Principal Investigator: Joseph Davies, MD Aurora Advanced Healthcare
Study Chair: Kenneth Greene, MD Crystal Clinic
Principal Investigator: Anthony Hedley, MD Arizona Institute for Bone and Joint Disorders
Principal Investigator: Kirby Hitt, MD Scott & White Memorial Hospital
Principal Investigator: Joseph McCarthy, MD Newton-Wellesley Hospital
Principal Investigator: Jeffrey Nassif, MD Physician's Clinic of Iowa, PC
Principal Investigator: Kenneth Krackow, MD Buffalo General Hospital, Department of Orthopaedics
Principal Investigator: Sean Scully, MD Cedars Medical Center University of Miami
Principal Investigator: Carlton Savory, MD Hughston Sports Medicine Center
Principal Investigator: Mathew Phillips, MD Buffalo General Hospital, Department of Orthopaedics
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00957723     History of Changes
Other Study ID Numbers: 56
Study First Received: August 10, 2009
Results First Received: June 13, 2013
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 27, 2014