Measuring Emphasys hip implant movement with radiostereometric analysis

Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of Emphasys Hip Solutions

This project will test how much the Emphasys hip shell and stem move during the first two years after a primary hip replacement in people with hip osteoarthritis or similar conditions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Canadian Radiostereometric Analysis Network (Academic / other)
• Locations: 1 site (Winnipeg, Manitoba)
• Trial ID: NCT06173713 on ClinicalTrials.gov

What this trial studies

This is a prospective, multi-centre, non-randomized, non-controlled study that uses model-based radiostereometric analysis (RSA) to measure implant migration. The primary endpoints are mean superior cup migration of the Emphasys Shell and mean inferior stem migration of the Emphasys Stem over the first two years post-implantation. Data collected will be compared to historical Pinnacle Acetabular Shell results (DSJ_2018_02). Subjects receive standard primary total hip arthroplasty care using the protocol-specified products and return for scheduled RSA imaging and hip outcome questionnaires.

Who should consider this trial

Good fit: Adults aged 21 or older who need a primary total hip replacement for severe pain or disability from osteoarthritis (or similar diagnoses), can give informed consent, complete study questionnaires, and return for follow-up visits are ideal candidates.

Not a fit: Patients with active local or systemic infection, significant loss of musculature, neuromuscular or vascular compromise, or those not able to attend follow-up visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could show that the Emphasys components remain stable after implantation, supporting their safe use and informing surgeons and patients about expected early fixation.

How similar studies have performed: Radiostereometric analysis is an established method that has been used successfully to detect early implant migration, and the protocol will compare results to existing Pinnacle RSA data.

Eligibility criteria

Inclusion Criteria:

1. Individuals requiring primary THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, AVN of the femoral head or acute traumatic fracture of the femoral head or neck.
2. Individuals who are able to speak, read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.
3. Individuals who are willing and able to return for follow-up as specified by the study protocol.
4. Individuals who are a minimum age of 21 years at the time of consent.
5. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol.

Exclusion Criteria:

1. Individuals who have active local or systemic infection.
2. Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery.
3. Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or require additional acetabular cup fixation using screws, or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
4. Individuals with Charcot's or Paget's disease.
5. Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA.
6. Women who are pregnant or lactating.
7. Individuals who have had a contralateral hip that was implanted less than 6 months prior to the time of consent into this study or individuals that expect to have a contralateral hip implanted in the following 6 months at the time of consent into this study.
8. Individuals that have amputations in either leg that would impact rehabilitation following surgery.
9. Individuals who are bedridden
10. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
11. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
12. Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
13. Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to sever stiffness and pain such as fibromyalgia or polymyalgia.
14. Subject has a medical condition with less than 2 years life expectancy.
15. Individual has a BMI \>45 kg/m2.

Where this trial is running

Winnipeg, Manitoba

• Orthopaedic Innovation Centre — Winnipeg, Manitoba, Canada (Recruiting)

Study contacts

• Principal investigator: Thomas Turgeon, MD — Concordia Hospital
• Study coordinator: Sarah Tran

Conditions Hip Osteoarthritis