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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03045536
Other study ID # 148/15
Secondary ID
Status Recruiting
Phase N/A
First received February 4, 2017
Last updated April 24, 2017
Start date January 1, 2016
Est. completion date April 1, 2019

Study information

Verified date February 2017
Source Technische Universität München
Contact norbert harrasser
Phone 15232716657
Email norbert.harrasser@gmx.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 1, 2019
Est. primary completion date March 1, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Total or partial femoral replacement

Exclusion Criteria:

- Failure of device

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MML (Fa. ESKA/Orthodynamics)
Classification of complications according to MSTS

Locations

Country Name City State
Germany Klinikum rechts der Isar Munich

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival of device Any device-related complications are defined failure 2 years