Clinical trial NCT04064008: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
Official title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Joint Disease
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-21
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem

Brief summary: Single center, prospective follow-up of previously implanted subjects

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

Eligibility criteria: 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.

Primary outcomes:
measure: Survivorship of ProFemur Z Stem out to 10 years
timeFrame: 10 years.
Secondary outcomes:
measure: Revision rate of the Profemur Z stem out to 10 years
timeFrame: 2-5 years, 5-7 years, and 10 years.
measure: to characterize total functional scores for subjects, as assessed by Oxford Hip Scores
timeFrame: 2-5 years, 5-7 years, and 10 years.
Other outcomes:
measure: to characterize total functional scores for subjects, as assessed by EQ-5D-3L scores.
timeFrame: 2-5 years, 5-7 years, and 10 years.
Locations:
city: Otwock
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Klinika
Study officials:
References: