Recruiting

Emphasys Shell

Sponsor:

Canadian Radiostereometric Analysis Network

Code:

NCT06173713

Conditions

Hip Osteoarthritis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Emphasys Hip Solutions

Study Details

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.

Conditions

Hip Osteoarthritis

Study ID

NCT06173713

Start date

Feb 11, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Emphasys Hip Solutions

Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem

Interventions

Emphasys Hip Solutions

Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem

Primary outcome measure

  • Migration - Shell [ Time Frame: 2 Years ]
  • Migration - Stem [ Time Frame: 2 Years ]

Central Contacts and Locations

Central contacts

Locations

Orthopaedic Innovation Centre

Recruiting

Winnipeg, Manitoba, Canada, R2K 2M9

Contacts

Principal Investigator:

Thomas Turgeon, MD

More Information

Sponsor

Canadian Radiostereometric Analysis Network

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Canadian Radiostereometric Analysis Network on 2025-12-10.