A prospective, non-randomized Roentgen Stereophotogrammetric Analysis study of the Stryker Accolade II(R) Hip Stem

Not Applicable

Completed

• Conditions: Osteoarthritis of the hip; Musculoskeletal - Osteoarthritis; Surgery - Surgical techniques

• Registration Number: ACTRN12611000954921
• Lead Sponsor: Stryker Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. The patient is a male or non-pregnant female between the ages of 20-80.
2. The patient is a candidate for a primary cementless total hip replacement using the study devices.
3. The patient has a primary diagnosis of non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
4. The patient has signed the study specific, HREC-approved, Informed Consent document.
5. The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

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. The patient is obese (BMI >= 40).
4. The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
5. The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
6. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
7. Patient has a cognitive impairment, an intellectual disability or a mental illness.
8. The patient is pregnant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the migration pattern (translations and rotations) of the Accolade II(R) stem during the first 2 years post-surgery. This will be assessed via measurement on x-rays of any micromotion of tantalum bead markers that were inserted at the time of surgery.[Pre-operative<br>Intra-operative<br>Post-Operative - 3 months<br>Post-Operative - 6 months<br>Post-operative - 12 months<br>Post-operative - 24 months]