FracturePelvicRetroNCT02591043
Surgical Treatment of Low Energy Pelvic Fractures in the Elderly
A study testing Outcome after surgery in people with Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Since May 2010 the Department of Trauma, Basel University Hospital has performed surgical stabilisation of the posterior pelvic ring on 55 patients. These patients have not received a structured follow up examination or evaluation of outcome after surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fracture
- What is being tested?
- Outcome after surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Sep 2016
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patients (age ≥55y ears) of any ethnic / sociodemographic background
- Pelvic ring fracture after low energy trauma affecting the posterior ring or both (posterior and anterior ring)
- Surgical stabilisation of the pelvic ring at Basel University Hospital between May 2010 and December 2014
- Ambulatory before surgery
- Informed consent for study participation by the patient or legal representatives
Who cannot join
- Refusal of consent by the patient or legal representatives to participate in the study
- Fractures within the last 3 months before follow-up
- Suspicion of a pathological fracture in the context of known or unknown malignancy
- Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc.
- Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient in a wheel chair)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Surgical Treatment of Low Energy Pelvic Ring Fractures in the Elderly: Cross-sectional Single-centre Study From Basel, Switzerland
Since May 2010 the Department of Trauma, Basel University Hospital has performed surgical stabilisation of the posterior pelvic ring on 55 patients. These patients have not received a structured follow up examination or evaluation of outcome after surgery.
Read the detailed description
Functional outcome of elderly patients with surgical treatment of low energy pelvic ring fractures.
- Conditions
- Fracture
- Being tested
- Outcome after surgery
- Keywords
- Pelvic, Treatment Outcome
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outcome after surgeryProcedure or surgery
Functional outcome after surgical treatment of pelvic ring fractures Measurements: TUG-test score, ADLs index, maximal pain (VAS 1-10) at rest and experienced during TUG-test. One-year mortality, signs of healing, dislocation or other complications on anterior-posterior radiographs of the pelvis, living situation before and after the injury (at home/institutional placement)
| Study group | Role | What they receive |
|---|---|---|
| Follow-up | Other | Patients have not received a structured follow up examination or evaluation of outcome after surgery. Therefore this study aims at conducting a follow up examination regarding functional outcome, pain and radiologic healing in these patients. Receives: Procedure: Outcome after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
TUG-Test through study completion, an average of 1 year
TUG test - according test description
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
activity of daily living (ADL) through study completion, an average of 1 year
ADL test - according test description
Measured: through study completion, an average of 1 year
Pain test through study completion, an average of 1 year
Maximal pain (VAS 1-10) experienced during TUG-test and at rest at the day of follow up
Measured: through study completion, an average of 1 year
Living Situation through study completion, an average of 1 year
Living situation before and after the injury (at home/institutional placement) according test procedure
Measured: through study completion, an average of 1 year
1-year mortality
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Hasler, Dr, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591043
- Sponsor's protocol ID
- 2015-299
- Acronym
- PelvicRetro
- Status last verified
- Sep 2016
- First submitted
- 8 Oct 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rommens PM, Hofmann A. Comprehensive classification of fragility fractures of the pelvic ring: Recommendations for surgical treatment. Injury. 2013 Dec;44(12):1733-44. doi: 10.1016/j.injury.2013.06.023. Epub 2013 Jul 18.
PubMed 23871193
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Low Energy Pelvic Ring Fractures in the Elderly: Cross-sectional Single-centre Study From Basel, Switzerland
- ClinicalTrials.gov ID
- NCT02591043
- Acronym / sponsor ID
- PelvicRetro / 2015-299
- Conditions
- Fracture
- Keywords
- Pelvic, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Oct 2015 (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.
Since May 2010 the Department of Trauma, Basel University Hospital has performed surgical stabilisation of the posterior pelvic ring on 55 patients. These patients have not received a structured follow up examination or evaluation of outcome after surgery.
Detailed description
Functional outcome of elderly patients with surgical treatment of low energy pelvic ring fractures.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up | Other | Procedure: Outcome after surgeryPatients have not received a structured follow up examination or evaluation of outcome after surgery. Therefore this study aims at conducting a follow up examination regarding functional outcome, pain and radiologic healing in these patients. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Elderly patients (age ≥55y ears) of any ethnic / sociodemographic background
- Pelvic ring fracture after low energy trauma affecting the posterior ring or both (posterior and anterior ring)
- Surgical stabilisation of the pelvic ring at Basel University Hospital between May 2010 and December 2014
- Ambulatory before surgery
- Informed consent for study participation by the patient or legal representatives
Key exclusion criteria (5 listed)
- Refusal of consent by the patient or legal representatives to participate in the study
- Fractures within the last 3 months before follow-up
- Suspicion of a pathological fracture in the context of known or unknown malignancy
- Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc.
- Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient in a wheel chair)
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 |
|---|---|---|
| Outcome after surgeryFunctional outcome after surgical treatment of pelvic ring fractures Measurements: TUG-test score, ADLs index, maximal pain (VAS 1-10) at rest and experienced during TUG-test. One-year mortality, signs of healing, dislocation or other complications on anterior-posterior radiographs of the pelvis, living situation before and after the injury (at home/institutional placement) | Procedure or surgery | Follow-up |
Primary outcome
TUG-Test through study completion, an average of 1 year
Time frame: through study completion, an average of 1 year
TUG test - according test description
4 secondary outcomes
activity of daily living (ADL) through study completion, an average of 1 year
Time frame: through study completion, an average of 1 year
Pain test through study completion, an average of 1 year
Time frame: through study completion, an average of 1 year
Living Situation through study completion, an average of 1 year
Time frame: through study completion, an average of 1 year
1-year mortality
Time frame: one year after surgery
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 29 Sep 2016.
- Background: PubMed 23871193Rommens PM, Hofmann A. Comprehensive classification of fragility fractures of the pelvic ring: Recommendations for surgical treatment. Injury. 2013 Dec;44(12):1733-44. doi: 10.1016/j.injury.2013.06.023. Epub 2013 Jul 18.
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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.
Rebecca Hasler, Dr principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outcome after surgery in people with Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 5 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 29 Sep 2016. 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 Switzerland. 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?
TUG-Test through study completion, an average of 1 year (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591043, which also lists 1 linked publication.
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 29 Sep 2016.