Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

Exactech

Status: Withdrawn

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

Treatments: Device: Optetrak Hi-Flex; Device: Optetrak PS

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808613

CR07-001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Optetrak Posterior Stabilized TKR

Active Comparator group

Description:

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

Treatment:

Device: Optetrak PS

Optetrak Hi-Flex TKR

Active Comparator group

Description:

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

Treatment:

Device: Optetrak Hi-Flex