- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00958789
Triathlon Total Stabilizer (TS) Outcomes Study
A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85023
- The Core Institute
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Florida
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Jacksonville, Florida, United States, 32204
- Heekin Institute for Orthopedic Research
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Illinois
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Chicago, Illinois, United States, 60612
- Midwest Orthopaedics at Rush
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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New Jersey
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Egg Harbor Township, New Jersey, United States, 08234
- Rothman Institute
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Ridgewood, New Jersey, United States, 07450
- Ridgewood Orthopedics
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New York
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East Syracuse, New York, United States, 13057
- Upstate Bone and Joint Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina Orthopedics
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Durham, North Carolina, United States, 27703
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45255
- Wellington Orthopaedic & Sports Medicine
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Oklahoma
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Tulsa, Oklahoma, United States, 74120
- The Orthopaedic Center
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Texas
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Temple, Texas, United States, 76508
- Scott & White Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient has signed an Institutional Review Board (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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Triathlon TS Knee
Triathlon TS Knee System
|
Total knee replacement for revision cases
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
Time Frame: pre-op, 2 years
|
KSS Pain score, KSS Function score, Total Combined KSS The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (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. Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200). |
pre-op, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Time Frame: 2 years, 5 years
|
This outcome measure shows the results of the KSS Functional Score for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to > 5mm. The Functional Score of the Knee Society Clinical Rating System ranges from a potential minimum score of 0 to a maximum score of 100 points. It is based on points assigned to ability to walk, climb stairs and the use of ambulatory aids. A higher value represents a better outcome. |
2 years, 5 years
|
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Time Frame: 2 year and 5 year postoperative
|
Measures the knee stability results for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by amount in mm that the joint line was restored to physiological joint line postoperative. One group were restored to ≤ 5 mm and the other were restored to > 5mm. Knee stability is evaluated in the anterior-posterior (AP) and medial-lateral (ML) planes. AP drawer test determines instability in mm of the tibia. It was done in the AP plane in both JLR groupings (≤ 5mm and > 5mm) at 2 years and 5 years. The AP measurements were sub categorized into 5mm and 5-10mm. ML is tested with a varus valgus stress test to determine any instability as measured in degrees. The ML measurements were done in both JLR groupings (≤ 5mm and > 5mm) at 2 years and 5 years with all results in only one category of < 5 degrees. The higher the number of degrees or mm measured the more instability in the knee. |
2 year and 5 year postoperative
|
Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Time Frame: 2 year and 5 year postoperative
|
Measures the presence or absence of anterior knee pain in the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to > 5mm. Anterior knee pain is determined by clinical examination with patient and clinician whether it is present or absent. |
2 year and 5 year postoperative
|
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
Time Frame: pre-op, 1, 2, 5 years
|
The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being.
It includes a physical and mental status component score; each ranging from 0-100.
Low values represent a poor health state and high values represent a good health state.
|
pre-op, 1, 2, 5 years
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Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
Time Frame: 1, 2, 5 years
|
The scoring system was based on the Knee Society guidelines and determined by measuring the width of the radiolucent lines for each of the zones of the implant components in millimeters. The total widths are added for each zone which produces a numerical score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Failure is defined as a score of 10 or greater, regardless of symptoms and considered as radiographic instability. |
1, 2, 5 years
|
Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component
Time Frame: 5 years
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Revision was defined as the removal of either the femoral component or the tibial baseplate component.
|
5 years
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
Time Frame: pre-op, 1, 2, 5 years
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KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
The last week is taken into consideration when answering the questions.
Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
|
pre-op, 1, 2, 5 years
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Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
Time Frame: pre-op, 1, 2, 5 years
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The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint.
It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.
|
pre-op, 1, 2, 5 years
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Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
Time Frame: pre-op, 1, 2, 5 years
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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.
|
pre-op, 1, 2, 5 years
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Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Time Frame: pre-op, 1,2, 5 year
|
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.
|
pre-op, 1,2, 5 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kirby D Hitt, M.D., Scott & White Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 65
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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