Accolade® TMZF® Hip Stem Outcomes Study

Completed · Not applicable

Conditions studied: Arthroplasty, Replacement, Hip

In brief

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

Key facts

Study ID

NCT00957658

Run by

Stryker Orthopaedics

People needed

241

Starts

2006-03-01

Expected to finish

2014-05-01

Last updated by the study team

2017-08-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Newport Orthopaedic Institute — Newport Beach, California, United States
• Alvarado Ortho Medical Group — San Diego, California, United States
• Orthopaedic Surgery Associates — Boynton Beach, Florida, United States
• Coastal Orthopaedics — Bradenton, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Hughston Clinic P.A. — Columbus, Georgia, United States
• Plymouth Bay Ortho Association — Duxbury, Massachusetts, United States
• New England Orthopaedic Surgeons — Springfield, Massachusetts, United States
• Specialty Orthopaedics — Harrison, New York, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• Northwest Orthopaedic Institute — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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