M-Vizion™ Macroscopic Radiographic Study
ConditionRevision Hip Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-80
SponsorMedacta USA
About this trial
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
Ability to understand and provide written authorization for use and disclosure of personal health information.
Subjects who are able and willing to comply with the study protocol and follow-up visits.
Patients requiring a revision total hip replacement.
Disqualifiers
Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
Patients bone stock is compromised by disease or infection, which could possibly prevent adequate support and/or fixation to the prosthesis.
Patients with an active or suspected latent infection in or about the hip joint.
Trial population
Patients listed for revision THA receiving a M-Vizion femoral component and meeting all inclusion/ exclusion criteria at a research site,
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
revision hip arthroplasty
Devicerevision hip arthroplasty
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
subsidence
Occurrence of subsidence \>5mm
Time frame
6 weeks post-op visit (± 2 weeks)2
subsidence
Occurrence of subsidence \>5mm
Time frame
6 Months post-op visit (± 2 months)3
subsidence
Occurrence of subsidence \>5mm
Time frame
1 year post-op visit (± 4 months)4
subsidence
Occurrence of subsidence \>5mm
Time frame
2 year post-op visit (± 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov