Enrolling by invitation NCT04064008

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems

— Observational Joint Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: PROFEMUR® Z Revision Femoral Stem.
Who it may be relevant to: Registry conditions: Joint Disease. Basic parameters: No limits · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Poland
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Single center, prospective follow-up of previously implanted subjects

Detailed description

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems

Secondary outcome measures (2)

Revision rate of the Profemur Z stem out to 10 years [Time frame: 2-5 years, 5-7 years, and 10 years.]
to characterize total functional scores for subjects, as assessed by Oxford Hip Scores [Time frame: 2-5 years, 5-7 years, and 10 years.]

Has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone).
Subject is implanted with the PROFEMUR® Z Revision Femoral Stem at the time of their revision THA.
Subject is willing and able to complete required study visits or assessments.
Plans to be available through the 10 year postoperative follow-up visit.

Previously implanted bilateral subjects can have both THAs enrolled in the study provided:

the PROFEMUR Z Revision Femoral Stem was implanted in both,
all other aspects of the Inclusion/Exclusion Criteria are satisfied,
enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.

Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol.
Subject has a PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 implanted in the enrolled THA.
Has or had an overt infection at the time of implantation.
Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation.
Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation.
Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable.
Subjects unwilling to sign the Informed Consent document.
Subjects with substance abuse issues.
Subjects with an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
Subjects who are incarcerated or have pending incarceration.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Poland · 1 center

NCT: NCT04064008 · 12-LJH-002M