Evaluation of Partial and Total Femoral Replacement

NCT ID: NCT03045536

Last Updated: 2017-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Survival, Prostheses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with TFR

Patients treated with TFR for oncologic or non-oncologic reason

MML (Fa. ESKA/Orthodynamics)

Intervention Type DEVICE

Classification of complications according to MSTS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MML (Fa. ESKA/Orthodynamics)

Classification of complications according to MSTS

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Total or partial femoral replacement

Exclusion Criteria

* Failure of device
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Harrasser

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

norbert harrasser

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinikum rechts der Isar

Munich, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

norbert harrasser

Role: CONTACT

15232716657

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

norbert harrasser

Role: primary

15232716657

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

148/15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Selecting the Right Hip Prosthesis for Young Patients
NCT03279276 ACTIVE_NOT_RECRUITING NA
Subsidence of Short Stem THA With DORR Type C
NCT06768541 ACTIVE_NOT_RECRUITING
PROMIS Evaluation Study
NCT05734651 RECRUITING