Post Market Clinical Follow-Up Study Protocol for PROFEMU... | NCT04064008

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

NCT04064008

Sponsor

MicroPort Orthopedics Inc.

Status

Enrolling by invitation

Last Update Posted

Nov 14, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Joint Disease

Interventions

PROFEMUR® Z Revision Femoral Stem

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2019Actual

Primary Completion Date

Apr 2030Estimated

Completion Date

Apr 2030Estimated

First Submitted Date

May 18, 2019

First Submission Date that Met QC Criteria

Aug 19, 2019

First Posted Date

Aug 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2023

Last Update Posted Date

Nov 14, 2023Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Primary Total Hip Arthroplasty		Single study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem	Device: PROFEMUR® Z Revision Femoral Stem

Name	Type	Description	Arm Group Labels	Other Names
PROFEMUR® Z Revision Femoral Stem	Device	Total Hip Total Hip Arthroscopy	Primary Total Hip Arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survivorship of ProFemur Z Stem out to 10 years	Kaplan-Meier survivorship at specific intervals out to 10 years follow up	10 years.

Secondary Outcomes

Measure	Description	Time Frame
Revision rate of the Profemur Z stem out to 10 years	Cummulative revision rate at early (2-5yrs), midterm (5-7 year) and long-term (10 year) follow up.	2-5 years, 5-7 years, and 10 years.
to characterize total functional scores for subjects, as assessed by Oxford Hip Scores

Other Outcomes

Measure	Description	Time Frame
to characterize total functional scores for subjects, as assessed by EQ-5D-3L scores.	EQ-5D-3L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 3 levels: no problems, some problems, and extreme problems.	2-5 years, 5-7 years, and 10 years.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample