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This study has been withdrawn prior to enrollment.
(Study withdrawn prior to initiation)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
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 April 17, 2014