Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

This study has been withdrawn prior to enrollment.
(Study withdrawn prior to initiation)
Sponsor:
Information provided by:
Exactech
ClinicalTrials.gov Identifier:
NCT00808613
First received: December 15, 2008
Last updated: February 25, 2013
Last verified: February 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 0
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
Active Comparator: 1
Optetrak Posterior Stabilized
Device: Optetrak PS
Optetrak Posterior Stabilized total knee replacement
Active Comparator: 2
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Virginia
Hampton Roads Orthopedics
Newport News, Virginia, United States, 23606
Sponsors and Collaborators
Exactech
Investigators
Study Director: Jason Drenning, Ph.D. Exactech, Inc.
Principal Investigator: John W. Aldridge, MD Hampton Roads Orthopedics
  More Information

No publications provided

Responsible Party: John W. Aldridge M.D., Hampton Roads Orthopedics
ClinicalTrials.gov Identifier: NCT00808613     History of Changes
Other Study ID Numbers: CR07-001
Study First Received: December 15, 2008
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteonecrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014