Accolade TMZF Hip Stem Outcomes Study
This study is ongoing, but not recruiting participants.
Sponsor:
Stryker Orthopaedics
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
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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:
- Patient is a candidate for a primary total hip replacement.
- Patient has primary diagnosis of OA.
- Male and non-pregnant female patients ages 18 to 90.
- Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
- Patient capable of undergoing a pre-op central DXA scan for a BMD reading.
Exclusion Criteria:
- Patients with active infection within the affected hip joint.
- Patients requiring revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- Patients who are morbidly obese, Body Mass Index (BMI) > 40.
- Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- Patients with the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
- Patients who are immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
- 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 May 23, 2013