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Accolade® TMZF® Hip Stem Outcomes Study

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ClinicalTrials.gov Identifier: NCT00957658
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : August 15, 2014
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics

Study Description
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Brief Summary:
The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Device: Accolade® TMZF® Hip Stem Not Applicable

Detailed Description:
A prospective, post-market, multi-centered clinical evaluation of the Accolade® TMZF® hip stem device. All patients enrolled will receive the study device. All study patients will undergo a preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone mineral density (BMD) values.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accolade® TMZF® Study A Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade® TMZF® Hip Stem
Study Start Date : March 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem Study Device
 Device: Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem


Outcome Measures
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Primary Outcome Measures :
  1. Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Percentage (%) of Hip Stems With Aseptic Loosening [ Time Frame: 5 years ]
    Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view.

  2. Revision/Removal Rates [ Time Frame: 2 and 5 years ]
    The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals.

  3. Change in Harris Hip Score (HHS) [ Time Frame: Preoperative, 2 and 5 years ]
    The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.

  4. Change in SF-12 Score [ Time Frame: Preoperative, 2 and 5 years ]
    The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

  5. Change in Lower Extremity Activity Scale (LEAS) Score [ Time Frame: Preoperative, 2 and 5 years ]
    The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement.

  6. PEQ (Patient Expectation Questionnaire) Overall Satisfaction [ Time Frame: 6 months, 1 year and 2 years ]

    The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.

    EXPECTATIONS KEY:

    Participate in recreational activities (dancing,traveling,gardening)

    Exercise or participate in sports

    Independently perform household chores/daily routine

    Easily change position,sit to stand/stand to sit

    Remove need for cane crutch or walker

    Use stairs normally step by step

    Ability to sleep through night

    Maintain social activites,caring for someone,playing with children

    Use public transportation or drive

    Maintain psychological well-being

    Maintain sexual activity

    Maintain employment


  7. PEQ (Patient Evaluation Questionnaire) Percent Achievement [ Time Frame: 6 months, 1 year, 2 years ]

    The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.

    EXPECTATIONS KEY:

    Participate in recreational activities (dancing,traveling,gardening)

    Exercise or participate in sports

    Independently perform household chores/daily routine

    Easily change position,sit to stand/stand to sit

    Remove need for cane crutch or walker

    Use stairs normally step by step

    Ability to sleep through night

    Maintain social activites,caring for someone,playing with children

    Use public transportation or drive

    Maintain psychological well-being

    Maintain sexual activity

    Maintain employment


  8. Acetabular Insert Wear [ Time Frame: 5 years ]
    The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.

  9. Wrist DXA Scan Analysis [ Time Frame: 5 years ]
    DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is a candidate for a primary total hip replacement.
  2. Patient has primary diagnosis of osteoarthritis (OA).
  3. Male and non-pregnant female patients ages 18 to 90.
  4. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
  5. Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
  6. Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.

Exclusion Criteria:

  1. Patient has an active infection within the affected hip joint.
  2. Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
  3. Patient who is morbidly obese, Body Mass Index (BMI) > 40.
  4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
  5. Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
  6. Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
  7. Patient is a prisoner.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00957658


Locations
United States, California
Newport Orthopaedic Institute
Newport Beach, California, United States, 92660
Alvarado Ortho Medical Group
San Diego, California, United States, 92120
United States, Florida
Orthopaedic Surgery Associates
Boynton Beach, Florida, United States, 33435
Coastal Orthopaedics
Bradenton, Florida, United States, 34209
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
Hughston Clinic P.A.
Columbus, Georgia, United States, 31908
United States, Massachusetts
Plymouth Bay Ortho Association
Duxbury, Massachusetts, United States, 02332
New England Orthopaedic Surgeons
Springfield, Massachusetts, United States, 01107
United States, New York
Specialty Orthopaedics
Harrison, New York, United States, 10528
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 23907
United States, Washington
Northwest Orthopaedic Institute
Tacoma, Washington, United States, 98402
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Study Chair: Robert Krushell, MD Baystate Medical Center
Principal Investigator: Carlton Savory, MD Hughston Sports Medicine Center
Principal Investigator: Robert Zann, MD Boca Raton Community Hospital
Principal Investigator: Steven Gausewitz, MD Hoag Hospital
Principal Investigator: R. Scott Oliver, MD Jordan Hospital
Principal Investigator: Mary O'Connor, MD Mayo Clinic
Principal Investigator: Anthony Sanchez, MD Spartanburg Regional Health Service District, Inc
Principal Investigator: Mark Visk, MD Spartanburg Regional Health Service District, Inc
Principal Investigator: Steven Teeny, MD St. Clare Hospital
Principal Investigator: Alan Valadie, MD Coastal Orthopedics and Sports Medicine
Principal Investigator: Steven Zelicof, MD Sound Shore Medical Center of Westchester
Principal Investigator: James Bates, MD Alvarado Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00957658     History of Changes
Other Study ID Numbers: 59
First Posted: August 12, 2009    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: August 14, 2017
Last Verified: July 2016

Keywords provided by Stryker Orthopaedics:
Osteoarthritis