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Recruiting NCT06173713

Emphasys Radiostereometric Analysis

No phase Interventional Hip Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emphasys Hip Solutions.
Who it may be relevant to
Registry conditions: Hip Osteoarthritis. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of Emphasys Hip Solutions

Overview

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.

Interventions

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

Primary outcome measures

  • Migration - Shell [Time frame: 2 Years]
  • Migration - Stem [Time frame: 2 Years]
Secondary outcome measures (8)
  • Subsidence - Emphasys Shell [Time frame: 6 months, 1 Year]
  • Subsidence - Emphasys Stem [Time frame: 6 months, 1 Year]
  • Other RSA measurements - Emphasys Shell [Time frame: 6 Weeks, 6 months, 1 year and 2 years]
  • Other RSA measurements - Emphasys Stem [Time frame: 6 Weeks, 6 months, 1 year and 2 years]
  • Head Penetration (in mm) [Time frame: 1 year and 2 years]
  • HOOS Jr. [Time frame: Pre-op, 6 weeks, 6 months, 1 year and 2 years]
  • Harris Hip Score [Time frame: Pre-op, 6 weeks, 6 months, 1 year and 2 years]
  • Forgotten Joint Score (FJS-12) [Time frame: Pre-op, 6 weeks, 6 months, 1 year and 2 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Orthopaedic Innovation Centre — Winnipeg

Identifiers

NCT: NCT06173713 · B2023:099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗