A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement
NCT ID: NCT02373761
Last Updated: 2015-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
27 participants
OBSERVATIONAL
2015-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Stryker Triathlon Tritanium primary knee
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Stryker Orthopaedics
INDUSTRY
Scott Sporer
OTHER
Responsible Party
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Scott Sporer
Medical Director, Orthopedic Institute
Principal Investigators
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Scott Sporer, MD
Role: PRINCIPAL_INVESTIGATOR
Central DuPage Hospital
Locations
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Central DuPage Hospital
Winfield, Illinois, United States
Countries
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Central Contacts
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References
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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.
Other Identifiers
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15-034-CDH
Identifier Type: -
Identifier Source: org_study_id