Emphasys Radiostereometric Analysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Device: Emphasys Hip Solutions

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Tran; Phone Number: 204-926-1231; Email: stran@orthoinno.com
• Study Contact Backup: Name: Melissa Bridges; Phone Number: 204-926-1232; Email: mbridges@orthoinno.com

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 2M9
      • Orthopaedic Innovation Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2E1
      • Nova Scotia Health - Orthopedic
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Emphasys Hip Solutions; Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem	Device: Emphasys Hip Solutions; Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months, 1 Year
Subsidence - Emphasys Stem	RSA measured subsidence of the Emphasys Stemat 6 months and 1 year	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.	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.	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.	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.	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.	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.	Pre-op, 6 weeks, 6 months, 1 year and 2 years

Collaborators and Investigators

• Sponsor: Canadian Radiostereometric Analysis Network
• Collaborators: DePuy Synthes
• Investigators: Principal Investigator: Thomas Turgeon, MD, Concordia Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: B2023:099

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes