Optetrak Posterior Stabilized Versus Optetrak Hi-Flex - Full Text View

Sponsored by:	Exactech
Information provided by:	Exactech
ClinicalTrials.gov Identifier:	NCT00808613

Purpose

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.

Condition	Intervention	Phase
Total Knee Replacement Due to Osteoarthritis, Osteonecrosis, Rheumatoid Arthritis and/or Post-Traumatic Degenerative Problems	Device: Optetrak PS Device: Optetrak Hi-Flex	Phase IV

MedlinePlus related topics: Knee Replacement Osteoarthritis Osteonecrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective, Single-Center, Non-Randomized, Consecutive Series Clinical Study Comparing the Functional Differences Between a Standard Posterior Stabilized Total Knee Replacement and a High-Flexion Posterior Stabilized Total Knee Replacement

Further study details as provided by Exactech:

Primary Outcome Measures:

The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knee Society Score (KSS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Hospital for Special Surgery (HSS) Knee Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Patient Satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Implant survivorship [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Radiographic evaluation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Optetrak Posterior Stabilized	Device: Optetrak PS Optetrak Posterior Stabilized total knee replacement
2: Active Comparator Optetrak Hi-Flex	Device: Optetrak Hi-Flex Optetrak Hi-Flex total knee replacement

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808613

Contacts

Contact: Jason A Drenning, Ph.D.	(352) 377-1140 ext 771	jason.drenning@exac.com
Contact: Matt Christensen	352-377-1140	matt.christensen@exac.com

Locations

United States, Virginia
Hampton Roads Orthopedics	Recruiting
Newport News, Virginia, United States, 23606
Contact: Michelle Gee 757-218-1650
Principal Investigator: John Aldridge, M.D.

Sponsors and Collaborators

Exactech

Investigators

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

More Information

Responsible Party:	Hampton Roads Orthopedics ( John W. Aldridge M.D. )
Study ID Numbers:	CR07-001
Study First Received:	December 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808613
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Necrosis
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases
Bone Diseases

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009