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Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

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ClinicalTrials.gov Identifier: NCT00808613
Recruitment Status : Withdrawn (Study withdrawn prior to initiation)
First Posted : December 16, 2008
Last Update Posted : February 26, 2013
Sponsor:
Information provided by:
Exactech

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. The null hypothesis is that there is no difference in postoperative knee flexion between the Optetrak® PS and Optetrak® HF groups.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2008
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Knee Society Score (KSS) [ Time Frame: 2 years ]
  2. Hospital for Special Surgery (HSS) Knee Score [ Time Frame: 2 years ]
  3. Patient Satisfaction [ Time Frame: 2 years ]
  4. Implant survivorship [ Time Frame: 2 years ]
  5. Radiographic evaluation [ Time Frame: 2 years ]
  6. Complications [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Principal Investigator: John W. Aldridge, MD Hampton Roads Orthopedics

Responsible Party: John W. Aldridge M.D., Hampton Roads Orthopedics
ClinicalTrials.gov Identifier: NCT00808613     History of Changes
Other Study ID Numbers: CR07-001
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013

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