Emphasys Hip Implants for Osteoarthritis

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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the Emphasys Radiostereometric Analysis treatment for hip implants in osteoarthritis?

Radiostereometric analysis (RSA) is a precise tool used to detect early implant migration in hip replacements, which can help ensure the stability and effectiveness of hip implants over time. ^{1 2 3 4 5}

Is there any safety data available for Emphasys Hip Implants for Osteoarthritis?

The research articles provided do not contain specific safety data for Emphasys Hip Implants or Emphasys Radiostereometric Analysis in humans. ^{5 6 7 8 9}

How does the Emphasys Hip Implants treatment for osteoarthritis differ from other treatments?

The Emphasys Hip Implants treatment is unique because it involves a novel cementless femoral stem, which is designed to improve implant stability and reduce early migration, potentially leading to better long-term outcomes compared to traditional hip implants. ^{4 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Thomas Turgeon, MD

Principal Investigator

Concordia Hospital

Eligibility Criteria

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).

I am unable to get out of bed.

Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Surgical approach had minor association with femoral stem migration in total hip arthroplasty: radiostereometric analysis of 61 patients after 5-year follow-up. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A titanium plasma-sprayed cup with and without hydroxyapatite-coating: a randomised radiostereometric study of stability and osseointegration. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

A Superolateral Cam Lesion Location Increases Odds of Total Hip Arthroplasty 5 Years After Hip Arthroscopy. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Two-year migration characteristics of a novel cementless femoral stem: a radiostereometric analysis and clinical outcomes study. [2021]

5. Sweden pubmed.ncbi.nlm.nih.gov

Dose reduction does not impact the precision of CT-based RSA in tibial implants: a diagnostic accuracy study on precision in a porcine cadaver. [2023]

6. Sweden pubmed.ncbi.nlm.nih.gov

A clinical and radiographic 13-year follow-up study of 138 Charnley hip arthroplasties in patients 50-70 years old: comparison of university hospital data and registry data. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Denosumab in Cementless Total Hip Arthroplasty: Multivariate Reanalysis of 3D Femoral Stem Migration and the Influence on Outliers. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Outlier analysis in orthopaedics: use of CUSUM: the Scottish Arthroplasty Project: shouldering the burden of improvement. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Wear measurements with use of radiostereometric analysis in total hip arthroplasty with obscured femoral head. [2020]

11. Italy pubmed.ncbi.nlm.nih.gov

Changes in the femoral cortex as related to prosthetic stem. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Identification of femoral head center of bipolar hemiarthroplasy in radiostereometric analysis with elementary geometrical shape models. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Radiostereometry of hip prostheses. Review of methodology and clinical results. [2022]