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Triathlon Total Stabilizer (TS) Outcomes Study

NCT ID: NCT00958789

Last Updated: 2021-10-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2019-03-28

Brief Summary

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This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triathlon TS Knee

Triathlon TS Knee System

Group Type OTHER

Triathlon TS Knee System

Intervention Type DEVICE

Total knee replacement for revision cases

Interventions

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Triathlon TS Knee System

Total knee replacement for revision cases

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
* Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria

* Patient has a Body Mass Index (BMI) \> 40.
* Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
* Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* Patient has a failed unicondylar knee prosthesis.
* Patient has a known sensitivity to device materials.
* Patient is a prisoner.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirby D Hitt, M.D.

Role: STUDY_CHAIR

Scott & White Hospital

Locations

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The CORE Institute

Phoenix, Arizona, United States

Site Status

Heekin Institute for Orthopedic Research

Jacksonville, Florida, United States

Site Status

Midwest Orthopaedics at Rush

Chicago, Illinois, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Rothman Institute

Egg Harbor, New Jersey, United States

Site Status

Ridgewood Orthopedics

Ridgewood, New Jersey, United States

Site Status

Upstate Bone and Joint Center

East Syracuse, New York, United States

Site Status

University of North Carolina Orthopedics

Chapel Hill, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Wellington Orthopaedic & Sports Medicine

Cincinnati, Ohio, United States

Site Status

The Orthopaedic Center

Tulsa, Oklahoma, United States

Site Status

Scott & White Clinic

Temple, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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65

Identifier Type: -

Identifier Source: org_study_id