Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

August 29, 2022 updated by: Exactech

Prospective, Single-center, Non-randomized, Consecutive Series Study Comparing Functional Differences Between a Standard Posterior Stabilized TKR and a High-flexion Posterior Stabilized TKR

The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized ("Optetrak® PS", Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ ("Optetrak® HF", Exactech, Gainesville, FL) knee designs.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized ("Optetrak® PS", Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ ("Optetrak® HF", Exactech, Gainesville, FL) knee designs. The null hypothesis is that there is no difference in postoperative knee flexion between the Optetrak® PS and Optetrak® HF groups.

Study Type

Interventional

Phase

  • Not Applicable

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
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Hampton Roads Orthopedics

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

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient is indicated for total knee replacement with a posterior stabilized device.
  2. Patient is between the ages of 50 and 80 years old

  3. Patient has a Body Mass Index (BMI) < 35.0 using the following method (or comparable method)

    • BMI = Weight (lbs.) ÷ Height (in.)2 x 703

  4. Patient is skeletally mature.
  5. Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of studyrequired questionnaires.
  6. Patient is willing and able to review and sign a study Informed Consent.

Exclusion Criteria:

  1. Patient has a Body Mass Index (BMI) > 35.0 using the following method (or comparable method)

    • BMI = Weight (lbs.) ÷ Height (in.)2 x 703

  2. Patient is skeletally mature
  3. Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of study required questionnaires.
  4. Patient is willing and able to review and sign a study Informed Consent.

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

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Optetrak Posterior Stabilized TKR
Subjects in this arm will receive an Optetrak Posterior Stabilized total knee system.
Device: Optetrak PS
Optetrak Posterior Stabilized total knee replacement
ACTIVE_COMPARATOR: Optetrak Hi-Flex TKR
Subjects in this arm will receive an Optetrak Hi-Flex total knee system.
Device: Optetrak Hi-Flex
Optetrak Hi-Flex total knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.
Time Frame: 2 years
Physician assess range of motion in knee joint
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score (KSS)
Time Frame: 2 years
Validated physician assessed outcome
2 years
Hospital for Special Surgery (HSS) Knee Score
Time Frame: 2 years
Validated physician assessed outcome
2 years
Patient Satisfaction
Time Frame: 2 years
Visual Analog Scale (1-10) where 10 is best.
2 years
Implant survivorship
Time Frame: 2 years
Implant survivorship
2 years
Radiographic evaluation
Time Frame: 2 years
Radiographic analysis
2 years
Complications
Time Frame: 2 years
Adverse Events
2 years

Collaborators and Investigators

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

Sponsor

Exactech

Investigators

  • Study Director: Jason Drenning, Ph.D., Exactech
  • Principal Investigator: John W. Aldridge, MD, Hampton Roads Orthopedics

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 (ANTICIPATED)

December 1, 2008

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (ESTIMATE)

December 16, 2008

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR07-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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