A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement

Osteoarthritis of the Knee Clinical Trial

Official title:

A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02373761
• Other study ID #: 15-034-CDH
• Status: Not yet recruiting
• Phase: N/A
• First received: February 13, 2015
• Last updated: February 26, 2015
• Start date: February 2015

Study information

• Verified date: February 2015
• Source: Central DuPage Hospital
• Contact: Scott Sporer, MD
• Phone: 630-933-6254
• Email: scottsporer[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Stryker Triathlon Tritanium primary knee

Locations

Country	Name	City	State
United States	Central DuPage Hospital	Winfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Scott Sporer	Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

Ryd L, Albrektsson BE, Carlsson L, Dansgård F, Herberts P, Lindstrand A, Regnér 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years.		3 years	No
Secondary	Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires.		3 years	No