Evaluation of Partial and Total Femoral Replacement

• Conditions: Survival, Prostheses
• Interventions: Device: MML (Fa. ESKA/Orthodynamics)

• Registration Number: NCT03045536
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-04
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-07
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25
• Primary Completion: 2018-03-01
• Study Completion: 2019-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Total or partial femoral replacement

Exclusion Criteria

• Failure of device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with TFR	MML (Fa. ESKA/Orthodynamics)	Patients treated with TFR for oncologic or non-oncologic reason

Primary Outcome Measures

Name	Time	Method
Survival of device	2 years	Any device-related complications are defined failure

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 Munich, Germany