Clinical trial NCT02373761: A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement
Official title: A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis of the Knee
Lead sponsor: Central DuPage Hospital
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2015-02-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of patients undergoing total knee replacement with the Triathlon Tritanium knee components at Central DuPage Hospital.

Brief summary: This study seeks to find out if the tibial and patellar components of the Stryker Triathlon Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years.
timeFrame: 3 years
Secondary outcomes:
measure: Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires.
timeFrame: 3 years
Other outcomes:
Locations:
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
Study officials:
affiliation: Central DuPage Hospital
name: Scott Sporer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.