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

MicroPort

Status: Invitation-only

Conditions: Joint Disease

Treatments: Device: PROFEMUR® Z Revision Femoral Stem

Study type: Observational

Funder types: Industry

Identifiers

NCT04064008

12-LJH-002M

Details and patient eligibility

About

Single center, prospective follow-up of previously implanted subjects

Full description

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

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone).
2. Subject is implanted with the PROFEMUR® Z Revision Femoral Stem at the time of their revision THA.
3. Subject is willing and able to complete required study visits or assessments.
4. 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:

1. the PROFEMUR Z Revision Femoral Stem was implanted in both,
2. all other aspects of the Inclusion/Exclusion Criteria are satisfied,
3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
4. 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.

Exclusion criteria

1. Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol.
2. Subject has a PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 implanted in the enrolled THA.
3. Has or had an overt infection at the time of implantation.
4. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation.
5. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation.
6. 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.
7. Subjects unwilling to sign the Informed Consent document.
8. Subjects with substance abuse issues.
9. Subjects with an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
10. Subjects who are incarcerated or have pending incarceration.

Trial design

30 participants in 1 patient group

Primary Total Hip Arthroplasty

Description:

Single study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem

Treatment:

Device: PROFEMUR® Z Revision Femoral Stem