Triathlon Cruciate Retaining (CR) Outcomes Study
This study is ongoing, but not recruiting participants.
Sponsor:
Stryker Orthopaedics
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957723
First received: August 10, 2009
Last updated: August 25, 2011
Last verified: August 2011
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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 using pre-operative scores comparing them to post-operative scores in addition to being compared with a control group. The control group is Scorpio CR.
| Condition | Intervention |
|---|---|
|
Arthropathy of Knee Joint Osteoarthritis, Knee Avascular Necrosis of Bone |
Device: Triathlon (CR) Total Knee System |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, 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:
- To compare the active range of motion (ROM) values for subjects receiving the Triathlon CR Total Knee System with those of the a control group. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare health related quality of life (QOL), radiographic stability, and complications when compared with subject's pre-operative status as well as with the control group, where available. [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 500 |
| Study Start Date: | February 2005 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: Triathlon (CR) Total Knee System
The purpose is to evaluate the Triathlon CR Total Knee System.
The Triathlon Cruciate Retaining (CR) Total Knee System components are for cemented use in 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. The Triathlon Cruciate Retaining (CR) Total Knee System is also designed to provide better anatomic fit and efficiency in the operating room. 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.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The patient has signed the informed consent.
- The patient is able to comply with follow-up requirements including post-operative weight bearing restrictions and self-evaluations.
- The patient is a male or non-pregnant female between the ages of 21 - 80 at time of surgery.
- The patient requires a primary total knee replacement.
- The patient has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- The patient has intact collateral ligaments.
Exclusion Criteria:
- The patient has inflammatory arthritis.
- The patient is morbidly obese, BMI > 40.
- The patient has a history of total or unicompartmental reconstruction of the affected joint.
- The patient has had a high tibial osteotomy or femoral osteotomy.
- The patient has obvious charcot (a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device).
- The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- The patient is immunologically compromised, or receiving chronic steroids ( > 30 days).
- The patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prothesis.
- The patient has knee fusion to the affected joint.
- The patient has an active or suspected latent infection in or about the knee joint.
- The patient is a prisoner.
Contacts and Locations
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 | |
| Buffalo, New York, United States, 14203 | |
| United States, Ohio | |
| Crystal Clinic, Musculoskeletal Research Lab, Summa Health System | |
| Akron, Ohio, United States, 44333 | |
| 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 | |
| Milwaukee Orthopedics Groups | |
| 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 | Milwaukee Orthopedics Groups |
| Study Chair: | Kenneth Greene, MD | Musculoskeletal Research Lab, Summa Health System |
| 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 |
| Last Updated: | August 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Stryker Orthopaedics:
|
Arthroplasty, Replacement, Knee |
Additional relevant MeSH terms:
|
Joint Diseases Necrosis Osteonecrosis Osteoarthritis Osteoarthritis, Knee |
Musculoskeletal Diseases Pathologic Processes Bone Diseases Arthritis Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013