Survival, ProsthesesEFeReNCT03045536
Evaluation of Partial and Total Femoral Replacement
An observational study of Survival, Prostheses, run by Technical University of Munich at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Survival, Prostheses
- What is being tested?
- MML (Fa. ESKA/Orthodynamics)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2016to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Total or partial femoral replacement
Who cannot join
- Failure of device
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar
Munich, 80992
norbert harrasser, 15232716657, norbert.harrasser@gmx.net
About this study
Official title: Evaluation of Partial and Total Femoral Replacement Treated in a Single Orthopedic Centre
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.
- Conditions
- Survival, Prostheses
- Being tested
- MML (Fa. ESKA/Orthodynamics)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MML (Fa. ESKA/Orthodynamics)Device
Classification of complications according to MSTS
| Study group | Role | What they receive |
|---|---|---|
| Patients with TFR | Patients treated with TFR for oncologic or non-oncologic reason Receives: Device: MML (Fa. ESKA/Orthodynamics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of device
Any device-related complications are defined failure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Jan 2016
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survival, ProsthesesStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harrasser, Technical University of Munich
- Investigators
- norbert harrasser, Principal investigator, Klinikum rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045536
- Sponsor's protocol ID
- 148/15
- Acronym
- EFeRe
- Status last verified
- Feb 2017
- First submitted
- 4 Feb 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Partial and Total Femoral Replacement Treated in a Single Orthopedic Centre
- ClinicalTrials.gov ID
- NCT03045536
- Acronym / sponsor ID
- EFeRe / 148/15
- Conditions
- Survival, Prostheses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with TFR | – | Device: MML (Fa. ESKA/Orthodynamics)Patients treated with TFR for oncologic or non-oncologic reason |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Total or partial femoral replacement
Key exclusion criteria (1 listed)
- Failure of device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MML (Fa. ESKA/Orthodynamics)Classification of complications according to MSTS | Device | Patients with TFR |
Primary outcome
Survival of device
Time frame: 2 years
Any device-related complications are defined failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
norbert harrasser principal investigator
Klinikum rechts der Isar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survival, Prostheses, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact norbert harrasser (15232716657, norbert.harrasser@gmx.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of device (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.