Emphasys Hip Implants for Osteoarthritis

Not yet recruiting at 2 trial locations

Overseen By Shalini Hari Kumar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Radiostereometric Analysis Network

Must not be taking: Muscular disorder medications

Disqualifiers: Infection, Osteoporosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new hip implant treatment for individuals with severe hip pain from conditions like osteoarthritis or rheumatoid arthritis. The focus is on the stability of Emphasys hip implants over two years. Participants must have severe hip pain from arthritis or similar conditions and be willing to complete follow-ups and questionnaires. The study does not compare different treatments but examines results from those receiving Emphasys implants, evaluated using Emphasys Radiostereometric Analysis.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance future hip implant treatments.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking prescription medications for a muscular disorder that limits mobility, you may not be eligible to participate.

What prior data suggests that the Emphasys Hip Implants are safe for osteoarthritis patients?

Research shows that Emphasys Hip Implants are designed to assist patients at high risk of hip dislocation. Although specific safety data for these implants is not available, the Emphasys Acetabular Cups have undergone testing to ensure effective performance without cement, meaning they are placed in the body without additional adhesives.

This study phase typically does not provide detailed safety data, but the implants' use in medical settings suggests they are generally well-tolerated. However, potential participants should note that specific safety results for using these implants to treat osteoarthritis are not detailed in the available sources. Always consult a healthcare professional for more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Emphasys Hip Implants for osteoarthritis because they offer a fresh approach using advanced materials and design. Unlike traditional hip replacements that often use standard metal and polyethylene components, the Emphasys system utilizes an innovative AOX polyethylene liner designed to reduce wear and improve joint longevity. Additionally, the use of Radiostereometric Analysis aims to provide precise tracking of implant movement, potentially enhancing the accuracy and effectiveness of the implant placement. This combination of advanced materials and cutting-edge tracking technology sets the Emphasys Hip Implants apart from existing options, potentially leading to better outcomes for patients.

What evidence suggests that the Emphasys Hip Implants are effective for osteoarthritis?

Research has shown that Emphasys Hip Implants, which participants in this trial may receive, might help treat hip osteoarthritis. These implants feature a special design that avoids using cement, helping them stay in place and reducing the chance of movement. The design accommodates different hip shapes, making it suitable for many patients. Additionally, the hip socket part of the implant is designed to lower the risk of dislocation. These features suggest that Emphasys Hip Implants could offer a stable and secure option for people with hip osteoarthritis. ^{1 2 3 5 6}

Who Is on the Research Team?

Thomas Turgeon, MD

Principal Investigator

Concordia Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with hip osteoarthritis. Participants must follow the study's protocol and use specified products, but other treatment procedures are not restricted by the study.

Inclusion Criteria

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 complete the Subject Hip Outcomes questionnaires as specified by the study protocol.

I need a hip replacement due to severe pain or disability from joint conditions.

Exclusion Criteria

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 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Functional and health status will be measured with HOOS Jr., Forgotten Joint Score (FJS-12), and Harris Hip Score

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo hip implantation with Emphasys Hip Solutions

Surgical procedure

1 visit (in-person)

Post-operative Monitoring

RSA measurements and functional assessments at 6 weeks, 6 months, 1 year, and 2 years

2 years

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Emphasys Radiostereometric Analysis

Trial Overview The trial is testing Emphasys Hip Solutions' effectiveness in treating hip osteoarthritis. It focuses on measuring how much the Emphasys Shell and Stem migrate within two years after being implanted.

How Is the Trial Designed?

Group I: Emphasys Hip Solutions Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Canadian Radiostereometric Analysis Network

Lead Sponsor

Trials

9

Recruited

420+

DePuy Synthes

Industry Sponsor

Trials

33

Recruited

4,900+

Johnson & Johnson

Industry Sponsor

Trials

116

Recruited

167,000+

Published Research Related to This Trial

In a study of 2,146 patients undergoing elective knee, hip, and spine surgeries for degenerative conditions, the overall adverse event rate was 27%, with spinal surgeries having the highest rate of severe adverse events.

Key risk factors for adverse events included increasing age, male sex, longer operative duration, longer hospital stays, and undergoing revision surgery, highlighting the need for careful patient assessment and procedural efficiency improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. Millstone, DB., Perruccio, AV., Badley, EM., et al.[2017]

Citations

1. withpower.com withpower.com/trial/phase-osteoarthritis-in-the-hip-joint-2024-69518

Emphasys Hip Implants for Osteoarthritis · Info for Participants The Emphasys Hip Implants treatment is unique because it involves a novel cementless femoral stem, which is designed to improve implant stability and reduce ...

2. jnjmedtech.com jnjmedtech.com/en-US/product/emphasys-acetabular-solutions

EMPHASYS™ Acetabular Solutions | DePuy Synthes EMPHASYS Acetabular Solutions provides an enhanced ability to treat patients who are at high risk of dislocation 1 via an acetabular system that is designed ...

3. ctv.veeva.com ctv.veeva.com/study/emphasys-radiostereometric-analysis

Emphasys Radiostereometric Analysis - ClinicalTrials.Veeva The primary objective is to establish the mean superior cup migration of the Emphasys Shell and the mean inferior stem migration of the Emphasys ...

4. jnjmedtech.com jnjmedtech.com/en-US/product/emphasys-femoral-solutions

EMPHASYS™ Femoral Solutions | DePuy Synthes This stem design offers a better fit and surgical preparation for a variety of femur types, including narrow canals*1,5 and more consistency of intraosseous ...

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06631638

EMPHASYS Cup Positioning in THA With Non-Invasive ... The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221636.pdf

September 6, 2022 DePuy Ireland UC Hollace Rhodes Vice ... EMPHASYS Acetabular Cups are indicated for cementless use only. Performance Testing. The EMPHASYS Acetabular System was tested to demonstrate ...