| NCT ID | NCT06173713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Canadian Radiostereometric Analysis Network |
| Condition | Hip Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-02-11 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Thomas Turgeon, MD
PRINCIPAL INVESTIGATOR
Concordia Hospital
Frequently Asked Questions
Who can join the NCT06173713 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Hip Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06173713 currently recruiting?
Yes, NCT06173713 is actively recruiting participants. Contact the research team at stran@orthoinno.com for enrollment information.
Where is the NCT06173713 trial being conducted?
This trial is being conducted at Winnipeg, Canada.
Who is sponsoring the NCT06173713 clinical trial?
NCT06173713 is sponsored by Canadian Radiostereometric Analysis Network. The principal investigator is Thomas Turgeon, MD at Concordia Hospital. The trial plans to enroll 30 participants.