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

August 10, 2009
August 15, 2012
March 2006
July 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00957658 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Accolade TMZF Hip Stem Outcomes Study
Accolade TMZF Study An Open-label, Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade TMZF Hip Stem

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Arthropathy of Hip
  • 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
Experimental: Accolade TMZF Hip Stem
Accolade TMZF Hip Stem Study Device
Interventions:
  • Device: Accolade TMZF Hip Stem
  • Device: Accolade TMZF Hip Stem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
249
July 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00957658
59
No
Stryker Orthopaedics
Stryker Orthopaedics
Not Provided
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
Stryker Orthopaedics
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP