Triathlon Total Stabilizer (TS) Outcomes Study
This study is currently recruiting participants.
Verified April 2013 by Stryker Orthopaedics
Sponsor:
Stryker Orthopaedics
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00958789
First received: August 11, 2009
Last updated: April 12, 2013
Last verified: April 2013
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Purpose
This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. When available, the Triathlon® TS Extended Condyle Femur (ECF) may also be included. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.
| Condition | Intervention |
|---|---|
|
Arthropathy of Knee |
Device: Triathlon TS Knee System |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System |
Resource links provided by NLM:
Further study details as provided by Stryker Orthopaedics:
Primary Outcome Measures:
- To evaluate the change in outcomes from the preoperative time point to 2 years postoperative in cases implanted with the Triathlon® TS Total Knee System, with regard to both components of the Knee Society Score. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the effect of Joint Line restoration on postop stability, anterior knee pain & functional performance. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- To evaluate the change between preop & postop outcomes other than the KSS for the Triathlon® TS group, as well as the change for all outcomes before & after date of availability for the extended condylar design. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To review radiographic stability, revision rates and complications for those implanted with the Triathlon® TS Total Knee System. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 181 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Triathlon TS Knee
Triathlon TS Knee System
|
Device: Triathlon TS Knee System
Total knee replacement for revision cases
Other Name: Triathlon Total Stabilizer Knee System
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
- Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria:
- Patient has a Body Mass Index (BMI) > 40.
- Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
- Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- Patient has a failed unicondylar knee prosthesis.
- Patient has a known sensitivity to device materials.
- Patient is a prisoner.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958789
Contacts
| Contact: Michael S Howard | 201-831-5807 | michael.howard@stryker.com |
| Contact: Danielle Anthony | 201-831-5498 | danielle.anthony@stryker.com |
Locations
| United States, Florida | |
| Heekin Orthopaedic Institute for Research, Inc. | Recruiting |
| Jacksonville, Florida, United States, 32204 | |
| Contact: Gwen Gratto-Cox 904-674-2017 gwen@heekinortho.com | |
| Principal Investigator: David Heekin, M.D. | |
| United States, Massachusetts | |
| Tufts Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Nicole Kneeland 617-636-5159 nkneeland@tuftsmedicalcenter.org | |
| Principal Investigator: Eric Smith, MD | |
| United States, New Jersey | |
| Rothman Institute | Recruiting |
| Egg Harbor Township, New Jersey, United States, 08234 | |
| Contact: Anne Marie Madden 609-407-6446 annemarie.madden@rothmaninstitute.com | |
| Contact: Victoria Younger 609-667-7015 | |
| Principal Investigator: Fabio Orozco, MD | |
| Sub-Investigator: Alvin Ong, MD | |
| Ridgewood Orthopedics | Recruiting |
| Ridgewood, New Jersey, United States, 07450 | |
| Contact: Stephanie Harbeson 201-445-2830 ext 159 sharbeson@ridgewoodortho.com | |
| Principal Investigator: Mark Pizzurro, MD | |
| United States, North Carolina | |
| University of North Carolina Orthopedics | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Jenny Williams, BSN 919-966-2878 JBradfor@unch.unc.edu | |
| Principal Investigator: Del Gaizo Dan, MD | |
| United States, Ohio | |
| Wellington Orthopaedic & Sports Medicine | Recruiting |
| Cincinnati, Ohio, United States, 45255 | |
| Contact: Yvonne Gantenberg 513-924-3502 yvonne@wellingtonortho.com | |
| Principal Investigator: Joel Sorger, M.D. | |
| Sub-Investigator: Suresh Nayak, M.D. | |
| United States, Oklahoma | |
| The Orthopaedic Center | Recruiting |
| Tulsa, Oklahoma, United States, 74120 | |
| Contact: Andrea Pope 918-925-3230 apope@toctulsa.com | |
| Principal Investigator: Yogesh Mittal, MD | |
| United States, Texas | |
| Scott & White Clinic | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Chris Herrick 254-724-9292 cherrick@swmail.sw.org | |
| Principal Investigator: Kirby Hitt, MD | |
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
| Study Chair: | Kirby D Hitt, M.D. | Scott & White Hospital |
More Information
No publications provided
| Responsible Party: | Stryker Orthopaedics |
| ClinicalTrials.gov Identifier: | NCT00958789 History of Changes |
| Other Study ID Numbers: | 65 |
| Study First Received: | August 11, 2009 |
| Last Updated: | April 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013