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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064008
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.

Brief Summary:
Single center, prospective follow‐up of previously implanted subjects

Condition or disease Intervention/treatment
Joint Disease Device: PROFEMUR® Z Revision Femoral Stem

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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post Market Clinical Follow‐Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : April 2030
Estimated Study Completion Date : April 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Group/Cohort Intervention/treatment
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
Total Hip Total Hip Arthroscopy




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Single study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064008


Contacts
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Contact: Cagla Yazici, MS +31 20 545 0162 cyazici@ortho.microport.com
Contact: Karen Martin, RN, BSN, MBA 901-867-4712 Karen.Martin@ortho.microport.com

Locations
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Poland
Samodzielny Publiczny Szpital Kliniczny Klinika Recruiting
Otwock, Poland, 05-400
Contact: Jerzy Bialecki, MD         
Sponsors and Collaborators
MicroPort Orthopedics Inc.
Investigators
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Principal Investigator: Jerzy Bialecki, Dr. Samodzielny Publiczny Szpital Kliniczny Klinika
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Responsible Party: MicroPort Orthopedics Inc.
ClinicalTrials.gov Identifier: NCT04064008    
Other Study ID Numbers: 12-LJH-002M
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases