Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthropathy of Knee Arthritis and/or Post-traumatic Degenerative Problems

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optetrak Posterior Stabilized TKR

Subjects in this arm will receive an Optetrak Posterior Stabilized total knee system.

Group Type ACTIVE_COMPARATOR

Optetrak PS

Intervention Type DEVICE

Optetrak Posterior Stabilized total knee replacement

Optetrak Hi-Flex TKR

Subjects in this arm will receive an Optetrak Hi-Flex total knee system.

Group Type ACTIVE_COMPARATOR

Optetrak Hi-Flex

Intervention Type DEVICE

Optetrak Hi-Flex total knee replacement

Interventions

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Optetrak PS

Optetrak Posterior Stabilized total knee replacement

Intervention Type DEVICE

Optetrak Hi-Flex

Optetrak Hi-Flex total knee replacement

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No