Accolade TMZF Hip Stem Outcomes Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957658
First received: August 10, 2009
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

The hypothesis of this study is that the combined success rates for loosening, intra-operative femoral fracture and thigh pain is no worse for patients with osteoporotic bone than for patients with non-osteoporotic bone.


Condition Intervention
Arthropathy of 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 An Open-label, Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade TMZF Hip Stem

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • The combined success rates for aseptic loosening, intra-operative femoral fracture and thigh pain is no worse for patients with osteoporotic bone than for patients with non-osteoporotic bone [ Time Frame: 2 and 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Revision/removals, change in HHS, SF-12 & KAS at 2 & 5 yrs [ Time Frame: 2 and 5 years ] [ Designated as safety issue: Yes ]
  • Evaluate poly insert wear rates at 5 yrs [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Compare pre-op and post-op wrist DXA scans to assess progression of osteoporosis in both groups [ Time Frame: 2 and 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 249
Study Start Date: March 2006
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accolade TMZF Hip Stem
Accolade TMZF Hip Stem Study Device
Device: Accolade TMZF Hip Stem
Accolade TMZF Hip Stem
Device: Accolade TMZF Hip Stem
Subjects enrolled undergo total hip replacement using the Accolade TMZF hip stem device.
Other Name: Accolade TMZF Femoral Stem

Detailed Description:

An open-label, 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 BMD values. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) approval.

  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 OA.
  3. Male and non-pregnant female patients ages 18 to 90.
  4. Patient has signed an 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 scan for a BMD reading.

Exclusion Criteria:

  1. Patients with active infection within the affected hip joint.
  2. Patients requiring revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
  3. Patients who are morbidly obese, Body Mass Index (BMI) > 40.
  4. Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
  5. Patients with the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
  6. Patients who are immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
  7. Patients who are prisoners.
  Contacts and Locations
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
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stryker Orthopaedics:
Osteoarthritis

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 16, 2014