Periprosthetic FracturesNCT02391129
Locking Compression Plate Fixation Versus Revision- Prosthesis of Vancouver-B2, B3 and C Periprosthetic Femoral Fractures After Total Hip Replacement
An observational study of Periprosthetic Fractures, run by Medical University of Vienna.
Trial summary
The purpose of this study was to compare the clinical (range of motion, weight bearing, quality of life) and radiographic outcome (boney consolidation) between open reduction and internal fixation using locking compression plates with revision prosthesis using a non-cemented long femoral stem in a group of patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Fractures
- What is being tested?
- Operation for Periprosthetic fractures of the hip with stem loosening
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We retrospectively reviewed a consecutive series of 102 patients with Vancouver type-B2, B3 and C periprosthetic fractures and unstable femoral stem, which had been prospectively entered, in our hip-trauma database.
Who may be able to join
- Patients with Vancouver type- BlI, BIII and C fractures and unstable femoral prosthesis stem.
Who cannot join
- Patients with pathological fractures,
- Vancouver type-A, Bl, and
- stable femoral prosthesis stem,
- Patients with hemi - prosthesis and periprosthetic femoral fractures were excluded from final analysis.
About this study
The purpose of this study was to compare the clinical (range of motion, weight bearing, quality of life) and radiographic outcome (boney consolidation) between open reduction and internal fixation using locking compression plates with revision prosthesis using a non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C periprosthetic fracture after primary total hip replacement.
- Conditions
- Periprosthetic Fractures
- Being tested
- Operation for Periprosthetic fractures of the hip with stem loosening
- Medical subject headings
- Periprosthetic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operation for Periprosthetic fractures of the hip with stem looseningProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hyperion Prosthesis | Patients treated with the second generation long-stem revision prosthesis Receives: Procedure: Operation for Periprosthetic fractures of the hip with stem loosening | |
| Helios Prosthesis | Patients treated with the first generation long-stem revision prosthesis Receives: Procedure: Operation for Periprosthetic fractures of the hip with stem loosening | |
| Locking compression plate | Patients treated with LCP Receives: Procedure: Operation for Periprosthetic fractures of the hip with stem loosening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome (Range of Motion of the hip)
Range of Motion of the hip
Measured: follow up of at least 1 year
Radiographic Outcome (boney consolidation of the fracture)
boney consolidation of the fracture after 3 month, 6 month and at least 1 year after the operation
Measured: follow up of at least 1 year
Secondary outcomes (1)
Patient's Mobility (assessed by the Parker's Mobility Score)
Patient's Mobility assessed by the Parker's Mobility Score
Measured: follow up of at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic FracturesStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Joestl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391129
- Sponsor's protocol ID
- 1674/2014
- Status last verified
- Mar 2015
- First submitted
- 7 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locking Compression Plate Fixation Versus Revision- Prosthesis of Vancouver-B2, B3 and C Periprosthetic Femoral Fractures After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT02391129
- Acronym / sponsor ID
- 1674/2014
- Conditions
- Periprosthetic Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Mar 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.
The purpose of this study was to compare the clinical (range of motion, weight bearing, quality of life) and radiographic outcome (boney consolidation) between open reduction and internal fixation using locking compression plates with revision prosthesis using a non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C periprosthetic fracture after primary total hip replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyperion Prosthesis | – | Procedure: Operation for Periprosthetic fractures of the hip with stem looseningPatients treated with the second generation long-stem revision prosthesis |
| Helios Prosthesis | – | Procedure: Operation for Periprosthetic fractures of the hip with stem looseningPatients treated with the first generation long-stem revision prosthesis |
| Locking compression plate | – | Procedure: Operation for Periprosthetic fractures of the hip with stem looseningPatients treated with LCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We retrospectively reviewed a consecutive series of 102 patients with Vancouver type-B2, B3 and C periprosthetic fractures and unstable femoral stem, which had been prospectively entered, in our hip-trauma database.
Key inclusion criteria (1 listed)
- Patients with Vancouver type- BlI, BIII and C fractures and unstable femoral prosthesis stem.
Key exclusion criteria (4 listed)
- Patients with pathological fractures,
- Vancouver type-A, Bl, and
- stable femoral prosthesis stem,
- Patients with hemi - prosthesis and periprosthetic femoral fractures were excluded from final analysis.
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 |
|---|---|---|
| Operation for Periprosthetic fractures of the hip with stem loosening | Procedure or surgery | Helios Prosthesis, Hyperion Prosthesis, Locking compression plate |
Primary outcome
Clinical Outcome (Range of Motion of the hip)
Time frame: follow up of at least 1 year
Range of Motion of the hip
Radiographic Outcome (boney consolidation of the fracture)
Time frame: follow up of at least 1 year
boney consolidation of the fracture after 3 month, 6 month and at least 1 year after the operation
1 secondary outcome
Patient's Mobility (assessed by the Parker's Mobility Score)
Time frame: follow up of at least 1 year
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 18 Mar 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Periprosthetic Fractures, run by Medical University of Vienna.
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 4 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 18 Mar 2015. 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.
What does the primary outcome measure?
Clinical Outcome (Range of Motion of the hip) (time frame: follow up of at least 1 year). The study lists 2 primary outcomes in all. 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 18 Mar 2015.