- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373761
A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Hypothesis:
The investigators expect the tibial and patellar components of the Stryker Triathlon Tritanium knee to achieve adequate fixation to the underlying bone.
Secondary Hypotheses:
The investigators expect that there will be no continuous migration between one and two years post-operative in the Triathlon Tritanium components.
The investigators expect to see a correlation between radiolucent lines and migration characteristics using RSA.
The investigators expect that inducible displacement exams taken at 2 years post-operative will be able to distinguish between patients identified by RSA measurements as having inadequate fixation.
The investigators expect to see a significant difference in health status and functional outcomes before and after total knee replacement using the Triathlon Tritanium knee.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Scott Sporer, MD
- Phone Number: 630-933-6254
- Email: scottsporer@gmail.com
Study Contact Backup
- Name: Stefanie Miller, BS
- Phone Number: 630-933-6254
- Email: Stefanie.Miller@CadenceHealth.org
Study Locations
-
-
Illinois
-
Winfield, Illinois, United States, 60190
- Central DuPage Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Scheduled to undergo a total knee arthroplasty
- Patients between the ages of 18 and 80, inclusive
- Patient is a candidate for Triathlon Tritanium cementless knee components implanted in accordance with product labeling
Exclusion Criteria:
- Significant co-morbidity affecting ability to ambulate
- Prior arthroplasty, patellectomy or osteotomy with the affected knee
- Active or prior infection of the affected knee
- Morbid obesity (BMI > 40)
- Medical condition precluding major surgery
- Severe osteoporosis
- Neuromuscular impairment
- Pregnancy
- Inability to give informed consent
- Inability to return for follow-up visits for a minimum of two years after surgery
- Currently participating in any other surgical intervention study
- Known allergy to metals
- Flexion contracture greater than 15°
- Extension lag greater than 10°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Lateral or medial collateral ligament instability (> 10° varus/valgus)
- Leg length discrepancy greater than 10 mm
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years.
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.
- Pijls BG, Valstar ER, Nouta KA, Plevier JW, Fiocco M, Middeldorp S, Nelissen RG. Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop. 2012 Dec;83(6):614-24. doi: 10.3109/17453674.2012.747052. Epub 2012 Nov 9.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-034-CDH
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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