Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT04064008

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

Single center, prospective follow-up of previously implanted subjects

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Joint Disease Joint Diseases Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Samodzielny Publiczny Szpital Kliniczny Klinika

Otwock, 05-400, Poland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PROFEMUR® Z Revision Femoral Stem

Device

Total Hip Total Hip Arthroscopy

Primary outcomes

  1. Survivorship of ProFemur Z Stem out to 10 years

    Time frame: 10 years.

    Kaplan-Meier survivorship at specific intervals out to 10 years follow up

Secondary outcomes

  1. Revision rate of the Profemur Z stem out to 10 years

    Time frame: 2-5 years, 5-7 years, and 10 years.

    Cummulative revision rate at early (2-5yrs), midterm (5-7 year) and long-term (10 year) follow up.

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

    Time frame: 2-5 years, 5-7 years, and 10 years.

    The study will be reporting the final Oxford Hip score, which is a summary over 12 items. Each of these items is 5-level Likert scale such as from 'not at all' to 'totally'.

Other outcomes

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

    Time frame: 2-5 years, 5-7 years, and 10 years.

    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.

Sponsors and collaborators

Lead sponsor

MicroPort Orthopedics Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Aug 21, 2019
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.