Hip OsteoarthritisNCT06173713
Emphasys Radiostereometric Analysis
A study testing Emphasys Hip Solutions in people with Hip Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Emphasys Hip Solutions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 11 Feb 2025to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Individuals who are willing and able to return for follow-up as specified by the study protocol.
- Individuals who are a minimum age of 21 years at the time of consent.
- Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol.
Who cannot join
- Individuals who have active local or systemic infection.
- Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery.
- 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).
- Individuals with Charcot's or Paget's disease.
- Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA.
- Women who are pregnant or lactating.
Show all 15Show fewer
- 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.
- Individuals that have amputations in either leg that would impact rehabilitation following surgery.
- Individuals who are bedridden
- Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- 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.
- 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.
- Subject has a medical condition with less than 2 years life expectancy.
- Individual has a BMI >45 kg/m2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Orthopaedic Innovation Centre
Winnipeg, Manitoba, R2K 2M9
Sarah Tran, 204-926-1231, stran@orthoinno.com
Thomas Turgeon, MD
About this study
Official title: Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of Emphasys Hip Solutions
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
- Being tested
- Emphasys Hip Solutions
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emphasys Hip SolutionsDevice
Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem
| Study group | Role | What they receive |
|---|---|---|
| Emphasys Hip Solutions | Other | Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem Receives: Device: Emphasys Hip Solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration - Shell
The mean vertical subsidence (Y translation, also known as superior shell migration) at 2 years as measured with RSA.
Measured: 2 Years
Migration - Stem
The mean vertical subsidence (Y translation, also known as inferior stem migration) at 2 years as measured with RSA.
Measured: 2 Years
Secondary outcomes (8)
Subsidence - Emphasys Shell
RSA measured subsidence of the Emphasys Shell at 6 months and 1 year and to compare it to historical Pinnacle Shell data
Measured: 6 months, 1 Year
Subsidence - Emphasys Stem
RSA measured subsidence of the Emphasys Stemat 6 months and 1 year
Measured: 6 months, 1 Year
Other RSA measurements - Emphasys Shell
Other RSA measurements of the Emphasys Shell (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points. These endpoints will be compared to historical Pinnacle Shell data.
Measured: 6 Weeks, 6 months, 1 year and 2 years
Other RSA measurements - Emphasys Stem
Other RSA measurements of the Emphasys Stem (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points. These endpoints will be compared to historical Pinnacle Shell data.
Measured: 6 Weeks, 6 months, 1 year and 2 years
Head Penetration (in mm)
Linear head penetration (in mm) at 1 year and 2 years. This endpoint will be compared to historical Pinnacle data.
Measured: 1 year and 2 years
HOOS Jr.
Functional and health status will be measured with HOOS Jr. This is a patient-reported outcome measure for which scores range from 0 to 100; a score of 0 indicating total hip disability and 100 indicating optimal hip health.These endpoints will be compared to historical Pinnacle data.
Measured: Pre-op, 6 weeks, 6 months, 1 year and 2 years
Harris Hip Score
Functional score will be measured with Harris Hip Score. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). These endpoints will be compared to historical Pinnacle data.
Measured: Pre-op, 6 weeks, 6 months, 1 year and 2 years
Forgotten Joint Score (FJS-12)
Functional and health status will be measured with the Forgotten Joint Score (FJS-12). The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily lower degree of joint awareness. These endpoints will be compared to historical Pinnacle data.
Measured: Pre-op, 6 weeks, 6 months, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start11 Feb 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Radiostereometric Analysis Network
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Thomas Turgeon, MD, Principal investigator, Concordia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173713
- Sponsor's protocol ID
- B2023:099
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes