Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
ConditionArthropathy of Hip
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGruppo Bioimpianti S.r.l.
About this trial
Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients>18 years
Candidate for primary total hip replacement with femoral stem and acetabular cup
if ostheoarthritis patients aged 18 to 85 years
if femoral neck fracture patients aged 18 to 90 years
Disqualifiers
<18 years
if female, pregnant
patient who has already had primary hip surgery on the same side
local or disseminated neoplastic disease
Trial population
please see inclusion/exclusion criteria
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
hip arthroplasty with prosthesis
DeviceUse of femoral stem and acetabular cup for hip arthroplasty
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
stem survival rate
Kaplan Meier survival analysis
Time frame
1 year, 3 years, 5 and 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov