Subtrochanteric Femur FracturesNCT01520480
Pathological Subtrochanteric Fractures in 194 Patients
An observational study of Subtrochanteric Femur Fractures, run by Karolinska University Hospital.
Trial summary
In this study, the investigators analyze a consecutive series of patients operated for pathological subtrochanteric femur fracture to describe survival and reoperation rates after surgery and to identify risk factors for death. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Subtrochanteric Femur Fractures
- How many people
- 281 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Jan 2009
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pathological subtrochanteric femur fractures.
Who may be able to join
- All patients with pathological subtrochanteric femur fractures register in the Scandinavian Sarcoma Group Register
Who cannot join
None listed.
About this study
Official title: Pathological Subtrochanteric Fractures in 194 Patients. A Comparison of Outcome After Surgical Treatment of Pathological and Non-pathological Fractures.
In this study, the investigators analyze a consecutive series of patients operated for pathological subtrochanteric femur fracture to describe survival and reoperation rates after surgery and to identify risk factors for death. Moreover, the investigators include a cohort of patients with non-pathological subtrochanteric fractures for comparison.
Read the detailed description
The Scandinavian Sarcoma Group (SSG) has initiated a Skeletal Metastasis Register in 1999. The Register is a quality-control database which prospectively collects individual-based information on patients operated for skeletal metastases in the long bones and pelvis. Data on patient identity, age, sex, primary tumor, location of metastases, type of pathological fracture, and perioperative treatment were gathered. Information concerning surgical procedures such as method of fixation, type of implant, and postoperative complications are registered. Moreover, some clinical data such as pain levels (no, light, moderate, strong, or severe pain), pain medication use, mobility, and the Karnofsky performance score are recorded.
We will identify all patients surgically treated for pathological subtrochanteric femur fractures during 1999-2009.
The Stockholm Hip Fracture Group provides data on the reference group. During 2003, a consecutive series of patients with acute non-pathological subtrochanteric femur fractures treated in Stockholm were included in a prospective cohort study. The regional ethical review board located at the Karolinska Institutet approved the study (DNR 206/02).
The aim of this study is to analyze survival and reoperation rates of patients operated for pathological subtrochanteric femur fracture. We want compare those findings with a cohort of patients with non-pathological subtrochanteric fractures.
- Conditions
- Subtrochanteric Femur Fractures
- Keywords
- survival after surgery, Pathological Subtrochanteric Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-pathological fracture | Non pathological subtrochanteric femur fractures | |
| Pathological fracture | Pathological subtrochanteric fractures |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 1999
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subtrochanteric Femur FracturesStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudiger Weiss, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520480
- Sponsor's protocol ID
- 206/02
- Status last verified
- Jan 2012
- First submitted
- 25 Jan 2012
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathological Subtrochanteric Fractures in 194 Patients. A Comparison of Outcome After Surgical Treatment of Pathological and Non-pathological Fractures.
- ClinicalTrials.gov ID
- NCT01520480
- Acronym / sponsor ID
- 206/02
- Conditions
- Subtrochanteric Femur Fractures
- Keywords
- survival after surgery, Pathological Subtrochanteric Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Jan 1999
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 30 Jan 2012 (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.
In this study, the investigators analyze a consecutive series of patients operated for pathological subtrochanteric femur fracture to describe survival and reoperation rates after surgery and to identify risk factors for death. Moreover, the investigators include a cohort of patients with non-pathological subtrochanteric fractures for comparison.
Detailed description
The Scandinavian Sarcoma Group (SSG) has initiated a Skeletal Metastasis Register in 1999. The Register is a quality-control database which prospectively collects individual-based information on patients operated for skeletal metastases in the long bones and pelvis. Data on patient identity, age, sex, primary tumor, location of metastases, type of pathological fracture, and perioperative treatment were gathered. Information concerning surgical procedures such as method of fixation, type of implant, and postoperative complications are registered. Moreover, some clinical data such as pain levels (no, light, moderate, strong, or severe pain), pain medication use, mobility, and the Karnofsky performance score are recorded.
We will identify all patients surgically treated for pathological subtrochanteric femur fractures during 1999-2009.
The Stockholm Hip Fracture Group provides data on the reference group. During 2003, a consecutive series of patients with acute non-pathological subtrochanteric femur fractures treated in Stockholm were included in a prospective cohort study. The regional ethical review board located at the Karolinska Institutet approved the study (DNR 206/02).
The aim of this study is to analyze survival and reoperation rates of patients operated for pathological subtrochanteric femur fracture. We want compare those findings with a cohort of patients with non-pathological subtrochanteric fractures.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pathological fracture | – | –Non pathological subtrochanteric femur fractures |
| Pathological fracture | – | –Pathological subtrochanteric fractures |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pathological subtrochanteric femur fractures.
Key inclusion criteria (1 listed)
- All patients with pathological subtrochanteric femur fractures register in the Scandinavian Sarcoma Group Register
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 31 Jan 2012.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Subtrochanteric Femur Fractures, run by Karolinska University Hospital.
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 0 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 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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 31 Jan 2012.