Accolade® TMZF® Hip Stem Outcomes Study

Stryker

Status: Completed

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: Accolade® TMZF® Hip Stem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00957658

59

Details and patient eligibility

About

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

Full 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 preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone mineral density (BMD) values.

Enrollment: 241 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is a candidate for a primary total hip replacement.
2. Patient has primary diagnosis of osteoarthritis (OA).
3. Male and non-pregnant female patients ages 18 to 90.
4. Patient has signed an Institutional Review Board (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 (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.

Exclusion criteria

1. Patient has an active infection within the affected hip joint.
2. Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
3. Patient who is morbidly obese, Body Mass Index (BMI) > 40.
4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
5. Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
6. Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
7. Patient is a prisoner.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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241 participants in 1 patient group

Accolade® TMZF® Hip Stem

Other group

Description:

Accolade® TMZF® Hip Stem Study Device

Treatment:

Device: Accolade® TMZF® Hip Stem