Back to resultsOptetrak Posterior Stabilized Versus Optetrak Hi-Flex
Primary Purpose
Arthropathy of Knee, Arthritis and/or Post-traumatic Degenerative Problems
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optetrak PS
Optetrak Hi-Flex
Sponsored by
About this trial
This is an interventional treatment trial for Arthropathy of Knee
Eligibility Criteria
Inclusion Criteria:
- Patient is indicated for total knee replacement with a posterior stabilized device.
- Patient is between the ages of 50 and 80 years old
Patient has a Body Mass Index (BMI) < 35.0 using the following method (or comparable method)
• BMI = Weight (lbs.) ÷ Height (in.)2 x 703
- Patient is skeletally mature.
- 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.
- Patient is willing and able to review and sign a study Informed Consent.
Exclusion Criteria:
Patient has a Body Mass Index (BMI) > 35.0 using the following method (or comparable method)
• BMI = Weight (lbs.) ÷ Height (in.)2 x 703
- Patient is skeletally mature
- 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.
- Patient is willing and able to review and sign a study Informed Consent.
Sites / Locations
- Hampton Roads Orthopedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Optetrak Posterior Stabilized TKR
Optetrak Hi-Flex TKR
Arm Description
Subjects in this arm will receive an Optetrak Posterior Stabilized total knee system.
Subjects in this arm will receive an Optetrak Hi-Flex total knee system.
Outcomes
Primary Outcome Measures
The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.
Physician assess range of motion in knee joint
Secondary Outcome Measures
Knee Society Score (KSS)
Validated physician assessed outcome
Hospital for Special Surgery (HSS) Knee Score
Validated physician assessed outcome
Patient Satisfaction
Visual Analog Scale (1-10) where 10 is best.
Implant survivorship
Implant survivorship
Radiographic evaluation
Radiographic analysis
Complications
Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00808613
Brief Title
Optetrak Posterior Stabilized Versus Optetrak Hi-Flex
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn prior to initiation
Study Start Date
December 2008 (Anticipated)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exactech
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee, Arthritis and/or Post-traumatic Degenerative Problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optetrak Posterior Stabilized TKR
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive an Optetrak Posterior Stabilized total knee system.
Arm Title
Optetrak Hi-Flex TKR
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive an Optetrak Hi-Flex total knee system.
Intervention Type
Device
Intervention Name(s)
Optetrak PS
Intervention Description
Optetrak Posterior Stabilized total knee replacement
Intervention Type
Device
Intervention Name(s)
Optetrak Hi-Flex
Intervention Description
Optetrak Hi-Flex total knee replacement
Primary Outcome Measure Information:
Title
The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.
Description
Physician assess range of motion in knee joint
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Knee Society Score (KSS)
Description
Validated physician assessed outcome
Time Frame
2 years
Title
Hospital for Special Surgery (HSS) Knee Score
Description
Validated physician assessed outcome
Time Frame
2 years
Title
Patient Satisfaction
Description
Visual Analog Scale (1-10) where 10 is best.
Time Frame
2 years
Title
Implant survivorship
Description
Implant survivorship
Time Frame
2 years
Title
Radiographic evaluation
Description
Radiographic analysis
Time Frame
2 years
Title
Complications
Description
Adverse Events
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is indicated for total knee replacement with a posterior stabilized device.
Patient is between the ages of 50 and 80 years old
Patient has a Body Mass Index (BMI) < 35.0 using the following method (or comparable method)
• BMI = Weight (lbs.) ÷ Height (in.)2 x 703
Patient is skeletally mature.
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.
Patient is willing and able to review and sign a study Informed Consent.
Exclusion Criteria:
Patient has a Body Mass Index (BMI) > 35.0 using the following method (or comparable method)
• BMI = Weight (lbs.) ÷ Height (in.)2 x 703
Patient is skeletally mature
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.
Patient is willing and able to review and sign a study Informed Consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Drenning, Ph.D.
Organizational Affiliation
Exactech
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John W. Aldridge, MD
Organizational Affiliation
Hampton Roads Orthopedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hampton Roads Orthopedics
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Optetrak Posterior Stabilized Versus Optetrak Hi-Flex
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