Stryker Triathlon Tritanium primary knee in Osteoarthritis of the Knee - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Osteoarthritis of the Knee

Intervention / Treatment

Device: Stryker Triathlon Tritanium primary knee

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

Observational

Enrollment (Anticipated)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Winfield, Illinois, United States, 60190
    - Central DuPage Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Scott Sporer

Collaborators

Stryker Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Estimate)