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Not yet recruiting NCT07080671

Clinical and Radiographic Outcomes of the JointMedica Polymotion Resurfacing (PHR) Device

Conditions: Healthy Real World Data Safety and Effectiveness Patient Reported Outcome (PRO)

Sponsor: JointMedica Inc.

trial.available_in: БГ
Overview
The goal of this observational study is to generate Real World Evidence (RWE) on the device performance of the Polymotion Hip Resurfacing (PHR) system and its use in patients who have been implanted with the device for the treatment of hip osteoarthritis. This study will assess the following endpoints: * The survivorship of the Acetabular Cup (Kaplan-Meier estimate) through 2 years of follow-up. * Radiographic success of the implanted cups, through quantitative motion analysis to assess migration of the acetabular cups. * Absence of subsequent surgical intervention at the acetabulum of there operated hip. * Absence of serious, device-related adverse events. * Patient reported outcomes through Harris Hip Score and SUSHI - UCLA Hip Score questionnaires.
Description
This is a retrospective and prospective study that will include a maximum of 70 patients who were implanted with the JointMedica Polymotion Hip Resurfacing (PHR) device in Canada, New Zealand and Australia. Patients will be invited to consent to participate in this study, which will require their attendance of a follow-up standard of care visit to gather clinical data on the safety and performance of their index hip, undergo an x-ray imaging and complete two questionnaires to assess their functionality and outcomes. Patient data will be entered into electronic data capture systems and x-rays will be submitted to a core imaging laboratory, MMI, for analysis to assess the state and position of their acetabular cup.
Who can participate
Inclusion Criteria: * Age 21 or above at the time of the surgery. * Have had the Polymotion Hip Resurfacing (PHR) (implanted between September 2020 to January 2025 * Written informed consent given by subject Exclusion Criteria: * There is no exclusion criteria for this study
Locations 3
Australia (1)
Mark Rickman
Adelaide
Canada (1)
Gateway Surgery Centre
Calgary , Alberta
New Zealand (1)
Orthopaedic Specialist Centre
Auckland
Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
21 Years
Healthy volunteers
No
Start date
25.07.2025
Completion date
31.12.2026
Registry ID
NCT07080671
Source
anzctr
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