Clinical and Radiographic Outcomes of the JointMedica Custom-Made Resurfacing Device
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorJointMedica Inc.
About this trial
The Custom Resurfacing (CR) Implants are indicated for use for the reduction or relief of pain and/or improved hip function all skeletally mature patients where a total joint replacement is indicated, and where there is no other suitable, commercially distributed device available.
The Resurfacing System is a metal-on-polyethylene hip resurfacing device consisting of a metallic femoral component and an acetabular component made of Vitamin E HXLPE with a titanium coating on its bone-contacting surface.
The custom-Made Hip Resurfacing System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 21 or above at the time of the surgery.
Have had the JointMedica Custom-Made Hip Resurfacing device implanted between September 2020 to January 2025
Written informed consent given by subject
Disqualifiers
There is no exclusion criteria for this study
Trial population
Subjects that underwent hip arthroplasty procedure with the JointMedica Custom-Made Hip Resurfacing device (V2.1+ Cup design) between September 2020 to January 2025. Subjects who have previously had the JointMedica Custom-Made Hip Resurfacing device implanted will be contacted to give consent to participate in the collection of additional follow-up visits described within this protocol.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
41 Participants
are grouped into 1 trial groupGroup A: Patient Group
Trial outcomes
Primary outcomes
1
Acetabular Cup Survivorship
The number of acetabular cups which are functional and not requiring additional surgical intervention following the primary implantation
Time frame
From the primary implantation to end through to 24 months and 27months+ post operation.2
Radiographic Success
Quantitative motion assessment of the acetabular cup at implantation and follow-up visit
Time frame
Between primary implantation surgery and post-operative review at 24-months and 27+ months.3
Serious Device-Related Adverse Events
Occurrence and severity of adverse events including necessitation of secondary surgical intervention.
Time frame
From primary implantation to post-operative visit at 24-months or 27+monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: