Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

Arthropathy of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00808613
• Other study ID #: CR07-001
• Status: Withdrawn
• Phase: N/A
• Start date: December 2008
• Est. completion date: January 2012

Study information

• Verified date: August 2022
• Source: Exactech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Optetrak PS
Optetrak Posterior Stabilized total knee replacement
• Optetrak Hi-Flex
Optetrak Hi-Flex total knee replacement

Locations

Country	Name	City	State
United States	Hampton Roads Orthopedics	Newport News	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.	Physician assess range of motion in knee joint	2 years
Secondary	Knee Society Score (KSS)	Validated physician assessed outcome	2 years
Secondary	Hospital for Special Surgery (HSS) Knee Score	Validated physician assessed outcome	2 years
Secondary	Patient Satisfaction	Visual Analog Scale (1-10) where 10 is best.	2 years
Secondary	Implant survivorship	Implant survivorship	2 years
Secondary	Radiographic evaluation	Radiographic analysis	2 years
Secondary	Complications	Adverse Events	2 years