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

A prospective, non-randomized Roentgen Stereophotogrammetric Analysis study to determine the migration pattern of the Stryker Accolade II(R) Hip Stem in patients undergoing total hip arthroplasty

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000954921

Acronym

AccoladeRSA-11

Enrollment

Registered

2011-09-05

Start date

2012-05-24

Completion date

2014-02-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to identify whether there is a difference in the micromotion of the Accolade II(R) cementless femoral stem between 6 months post-surgery and 2 years post-surgery, providing an indication of long-term fixation. Functional outcomes, pain and quality of life will also be assessed. This study is a prospective observational case series being performed at a single study centre. One Principle Investigator will perform all surgery for this study.

Interventions

Candidates in the study will be selected from a pool of patients undergoing total hip replacement. In order to evaluate the Accolade II femoral hip stem radiopaue tantalum bead markers will be inserted resulting in the standard operating time (typically 1-2 hours) being extended by approximately 10 minutes.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Healthy volunteers

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.

Outcome results