Actively Recruiting
Emphasys Radiostereometric Analysis
Led by Canadian Radiostereometric Analysis Network · Updated on 2025-12-10
30
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
C
Canadian Radiostereometric Analysis Network
Lead Sponsor
J
Johnson & Johnson
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed as a prospective, multi-centre, non-randomized, non-controlled study. This study does not limit the procedures involved in the treatment of the subject as long as the protocol specified products are utilized. The primary objective is to establish the mean superior cup migration of the Emphasys Shell and the mean inferior stem migration of the Emphasys Stem using model-based RSA over the first two years post-implantation. Additionally, the data from this study will be compared to historical Pinnacle Acetabular Shell data obtained in study DSJ\_2018\_02.
CONDITIONS
Official Title
Emphasys Radiostereometric Analysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals needing primary total hip arthroplasty for severe pain or disability from osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, or acute traumatic fracture of hip
- Able to speak, read, and understand the informed consent document and willing to provide consent
- Willing and able to return for follow-up visits as required by the study protocol
- At least 21 years old at time of consent
- Willing and able to complete hip outcome questionnaires as specified by the study protocol
You will not qualify if you...
- Active local or systemic infection
- Loss of musculature, neuromuscular or vascular compromise affecting rehabilitation
- Poor bone quality such as osteoporosis that may cause prosthesis migration or require extra fixation
- Diagnosis of Charcot's or Paget's disease
- Not suitable for protocol-approved components as judged by investigator
- Pregnant or lactating women
- Contralateral hip implanted less than 6 months before consent or planned within 6 months after consent
- Amputation in either leg affecting rehabilitation
- Bedridden individuals
- Participation in another investigational drug or device study within last 3 months
- Involvement in personal injury litigation, medical-legal, or worker's compensation claims
- Drug or alcohol abuse or psychological disorder affecting compliance
- Diagnosed muscular disorder limiting mobility due to severe stiffness and pain (e.g., fibromyalgia, polymyalgia)
- Medical condition with less than 2 years expected life span
- Body mass index over 45 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Orthopaedic Innovation Centre
Winnipeg, Manitoba, Canada, R2K 2M9
Actively Recruiting
Research Team
S
Sarah Tran
CONTACT
S
Shalini Hari Kumar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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