Status:
COMPLETED
Accolade® TMZF® Hip Stem Outcomes Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral 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 preoperati...
Eligibility Criteria
Inclusion
- Patient is a candidate for a primary total hip replacement.
- Patient has primary diagnosis of osteoarthritis (OA).
- Male and non-pregnant female patients ages 18 to 90.
- Patient has signed an Institutional Review Board (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 (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.
Exclusion
- Patient has an active infection within the affected hip joint.
- Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- Patient who is morbidly obese, Body Mass Index (BMI) \> 40.
- Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
- Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
- Patient is a prisoner.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00957658
Start Date
March 1 2006
End Date
May 1 2014
Last Update
August 14 2017
Active Locations (11)
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1
Newport Orthopaedic Institute
Newport Beach, California, United States, 92660
2
Alvarado Ortho Medical Group
San Diego, California, United States, 92120
3
Orthopaedic Surgery Associates
Boynton Beach, Florida, United States, 33435
4
Coastal Orthopaedics
Bradenton, Florida, United States, 34209