Clinical trial NCT06173713: Emphasys Radiostereometric Analysis
Official title: Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of Emphasys Hip Solutions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Canadian Radiostereometric Analysis Network
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2023-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Migration - Shell
timeFrame: 2 Years
measure: Migration - Stem
timeFrame: 2 Years
Secondary outcomes:
measure: Subsidence - Emphasys Shell
timeFrame: 6 months, 1 Year
measure: Subsidence - Emphasys Stem
timeFrame: 6 months, 1 Year
measure: Other RSA measurements - Emphasys Shell
timeFrame: 6 Weeks, 6 months, 1 year and 2 years
measure: Other RSA measurements - Emphasys Stem
timeFrame: 6 Weeks, 6 months, 1 year and 2 years
measure: Head Penetration (in mm)
timeFrame: 1 year and 2 years
measure: HOOS Jr.
timeFrame: Pre-op, 6 weeks, 6 months, 1 year and 2 years
measure: Harris Hip Score
timeFrame: Pre-op, 6 weeks, 6 months, 1 year and 2 years
measure: Forgotten Joint Score (FJS-12)
timeFrame: Pre-op, 6 weeks, 6 months, 1 year and 2 years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Orthopaedic Innovation Centre
state: Manitoba
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Concordia Hospital
name: Thomas Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References: