TumorNCT00873145
Management of Bone Defects Around the Elbow
An observational study of Tumor and Fracture, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background: Bone defects of the distal humerus require complex reconstructions, for which standard prostheses may be insufficient. The researchers therefore investigated the clinical and radiological outcome of elbow reconstructions by megaprostheses. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- HMRS
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2008to Jan 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with major bone defects around the elbow and/or distal humerus due to cancer or failed arthroplasty.
Who may be able to join
- HMRS of the elbow, distal humerus or total humerus
Who cannot join
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna Department of Orthopaedics
Vienna, 1090
About this study
Official title: Modular Prosthetic Reconstruction of Major Bone Defects of the Distal Humerus.
Background:
Bone defects of the distal humerus require complex reconstructions, for which standard prostheses may be insufficient. The researchers therefore investigated the clinical and radiological outcome of elbow reconstructions by megaprostheses.
Read the detailed description
Type of prosthesis:
STRYKER Humerus-HMRS
- Being tested
- HMRS
- Keywords
- Survival, Function, Infection, Revision, Loosening
- Medical subject headings
- Neoplasms, Fractures, Bone, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMRSProcedure or surgery
Modular prosthetic replacement of the humerus and elbow.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with major bone defects around the elbow. Receives: Procedure: HMRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival
Measured: 20 Years
Secondary outcomes (1)
Prosthetic Survival
Measured: 20 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionSep 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873145
- Sponsor's protocol ID
- funovics1
- Status last verified
- Mar 2009
- First submitted
- 31 Mar 2009
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modular Prosthetic Reconstruction of Major Bone Defects of the Distal Humerus.
- ClinicalTrials.gov ID
- NCT00873145
- Acronym / sponsor ID
- funovics1
- Keywords
- Survival, Function, Infection, Revision, Loosening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 Apr 2009 (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.
Background:
Bone defects of the distal humerus require complex reconstructions, for which standard prostheses may be insufficient. The researchers therefore investigated the clinical and radiological outcome of elbow reconstructions by megaprostheses.
Detailed description
Type of prosthesis:
STRYKER Humerus-HMRS
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: HMRSPatients with major bone defects around the elbow. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with major bone defects around the elbow and/or distal humerus due to cancer or failed arthroplasty.
Key inclusion criteria (1 listed)
- HMRS of the elbow, distal humerus or total humerus
Key exclusion criteria (1 listed)
- Unwillingness to participate
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 |
|---|---|---|
| HMRSModular prosthetic replacement of the humerus and elbow. | Procedure or surgery | 1 |
Primary outcome
Patient Survival
Time frame: 20 Years
1 secondary outcome
Prosthetic Survival
Time frame: 20 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tumor and Fracture, run by Medical University of Vienna at 1 site in Austria.
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: finished, as of the sponsor's last update on 15 Apr 2015. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Survival (time frame: 20 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 15 Apr 2015.