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

NCT04064008 | Enrolling By Invitation

• 1 other identifier: 12-LJH-002M
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Single center, prospective follow-up of previously implanted subjects

Conditions

Joint Disease

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Revision rate of the Profemur Z stem out to 10 years

  2-5 years, 5-7 years, and 10 years.

• to characterize total functional scores for subjects, as assessed by Oxford Hip Scores

  2-5 years, 5-7 years, and 10 years.

Other Outcomes (1)

• to characterize total functional scores for subjects, as assessed by EQ-5D-3L scores.

  2-5 years, 5-7 years, and 10 years.

Study Arms (1)

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

Interventions

PROFEMUR® Z Revision Femoral Stem DEVICE

Total Hip Total Hip Arthroscopy

Primary Total Hip Arthroplasty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Samodzielny Publiczny Szpital Kliniczny Klinika

Otwock, 05-400, Poland

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2019
• First Posted: August 21, 2019
• Study Start: April 4, 2019
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

PL (1)