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Evaluation of Partial and Total Femoral Replacement (EFeRe)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045536
Recruitment Status : Unknown
Verified February 2017 by Harrasser, Technische Universität München.
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Harrasser, Technische Universität München

Brief Summary:
Several surgical options for the reconstruction of massive bone defects have been described and include biologic methods with autografts and allografts, and the use of tumor endoprostheses (total femoral replacement, TFR). Several types of modular TFR are available, but nevertheless unpredictable outcomes and high complication rates have been described from most authors. The aim of the present study was to compare complication rates after TFR performed with modular total femur prosthesis MML (Fa. ESKA/Orthodynamics) in patients with and without malignant disease.

Condition or disease Intervention/treatment
Survival, Prostheses Device: MML (Fa. ESKA/Orthodynamics)

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Partial and Total Femoral Replacement Treated in a Single Orthopedic Centre
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : April 1, 2019

Group/Cohort Intervention/treatment
Patients with TFR
Patients treated with TFR for oncologic or non-oncologic reason
Device: MML (Fa. ESKA/Orthodynamics)
Classification of complications according to MSTS




Primary Outcome Measures :
  1. Survival of device [ Time Frame: 2 years ]
    Any device-related complications are defined failure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The investigators retrospectivel review our institution's database for patients who underwent resection of the partial or whole femur due to bone tumors or failed revision arthroplasties and reconstruction by TFR from January 1995 to January 2011.
Criteria

Inclusion Criteria:

  • Total or partial femoral replacement

Exclusion Criteria:

  • Failure of device

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): NCT03045536


Contacts
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Contact: norbert harrasser 15232716657 norbert.harrasser@gmx.net

Locations
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Germany
Klinikum rechts der Isar Recruiting
Munich, Germany, 80992
Contact: norbert harrasser    15232716657    norbert.harrasser@gmx.net   
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: norbert harrasser Klinikum rechts der Isar

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Responsible Party: Harrasser, Principal Investigator, Technische Universität München
ClinicalTrials.gov Identifier: NCT03045536    
Other Study ID Numbers: 148/15
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Prosthesis Failure
Postoperative Complications
Pathologic Processes