Emphasys Radiostereometric Analysis

NCT06173713 | Recruiting FDA Device

• 1 other identifier: B2023:099
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Migration - Shell

  The mean vertical subsidence (Y translation, also known as superior shell migration) at 2 years as measured with RSA.

  2 Years

• Migration - Stem

  The mean vertical subsidence (Y translation, also known as inferior stem migration) at 2 years as measured with RSA.

  2 Years

Secondary Outcomes (8)

• Subsidence - Emphasys Shell

  6 months, 1 Year

• Subsidence - Emphasys Stem

  6 months, 1 Year

• Other RSA measurements - Emphasys Shell

  6 Weeks, 6 months, 1 year and 2 years

• Other RSA measurements - Emphasys Stem

  6 Weeks, 6 months, 1 year and 2 years

• Head Penetration (in mm)

  1 year and 2 years

Study Arms (1)

Emphasys Hip Solutions

OTHER

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

Device: Emphasys Hip Solutions

Interventions

Emphasys Hip Solutions DEVICE

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

Emphasys Hip Solutions

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Canadian Radiostereometric Analysis Network: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Orthopaedic Innovation Centre

Winnipeg, Manitoba, R2K 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Turgeon, MD

  Concordia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Tran

CONTACT

204-926-1231; stran@orthoinno.com

Shalini Hari Kumar

CONTACT

204-926-1232; skumar@orthoinno.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 18, 2023
• Study Start: February 11, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CA (1)