Emphasys Radiostereometric Analysis
ConditionHip Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorCanadian Radiostereometric Analysis Network
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Emphasys Hip Solutions
DeviceEmphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Emphasys Hip SolutionsOther 1 intervention
Trial outcomes
Primary outcomes
1
Migration - Shell
The mean vertical subsidence (Y translation, also known as superior shell migration) at 2 years as measured with RSA.
Time frame
2 Years2
Migration - Stem
The mean vertical subsidence (Y translation, also known as inferior stem migration) at 2 years as measured with RSA.
Time frame
2 YearsSecondary outcomes
1
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
Time frame
6 months, 1 Year2
Subsidence - Emphasys Stem
RSA measured subsidence of the Emphasys Stemat 6 months and 1 year
Time frame
6 months, 1 Year3
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.
Time frame
6 Weeks, 6 months, 1 year and 2 years4
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.
Time frame
6 Weeks, 6 months, 1 year and 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Canadian Radiostereometric Analysis Network
Lead sponsor
Johnson & Johnson
Collaborator
Source ClinicalTrials.gov