Accolade® TMZF® Hip Stem Outcomes Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957658
First received: August 10, 2009
Last updated: July 26, 2015
Last verified: July 2015
  Purpose

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


Condition Intervention
Arthroplasty, Replacement, Hip
Device: Accolade® TMZF® Hip Stem

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage (%) of Hip Stems With Aseptic Loosening [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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.

  • Revision/Removal Rates [ Time Frame: 2 and 5 years ] [ Designated as safety issue: Yes ]
    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.

  • Change in Harris Hip Score (HHS) [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]
    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.

  • Change in SF-12 Score [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]
    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.

  • Change in Lower Extremity Activity Scale (LEAS) Score [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]
    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.

  • PEQ Data [ Time Frame: 6 months, 1 year and 2 years ] [ Designated as safety issue: No ]
    The PEQ (Patient Expectation Questionnaire) is a study sponsor generated outcomes form. It is a one page questionnaire completed by the patient to assess lifestyle recovery post-surgery. Preoperatively, patients 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 patients evaluated the 3 expectations they identified and assessed their percent achievement and overall satisfaction.

  • Acetabular Insert Wear [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.

  • Wrist DXA Scan Analysis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 241
Study Start Date: March 2006
Study Completion Date: May 2014
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem Study Device
Device: Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00957658     History of Changes
Other Study ID Numbers: 59
Study First Received: August 10, 2009
Results First Received: October 28, 2013
Last Updated: July 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Stryker Orthopaedics:
Osteoarthritis

ClinicalTrials.gov processed this record on August 27, 2015