Acetabular FractureNCT01839565
Quadrilateral Surface Plate (QSP) Focused Registry
An observational study of Acetabular Fracture, run by AO Clinical Investigation and Publishing Documentation at 6 sites in 3 countries.
Trial summary
The absence of methodologically, prospectively and retrospectively collected information on the use of the Quadrilateral Surface Plate (QSP) in the given indication requires a multicenter approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fracture
- What is being tested?
- Quadrilateral Surface Plate
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Oct 2012to Apr 2019
- How long will I take part?
- 24 Months
- 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: The increasing number of acetabular fractures in elderly individuals with osteoporosis has added new technical challenges to surgical management. A common group of fracture patterns in this population is the anterior wall or column often with an associated posterior hemitransverse. These injuries frequently also include quadrilateral surface comminution which can make both reduction and stabilization more difficult. The 3.5 mm quadrilateral surface plate was developed to provide a more effective way to deal with these issues, for example, a way to deal with the quadrilateral surface enbloc for reduction, allowing buttress stabilization, which is independent of bone density.
Who may be able to join
- Age 18 years or older
- Diagnosis of acetabular fracture requiring surgical fixation
- Ability to understand the content of the patient information / informed consent form
- Signed and dated IRB/EC-approved written informed consent
Who cannot join
- Any not medically managed severe systemic disease
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- Prisoner
- Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry
- Intraoperative exclusion criteria:
- Intraoperative decision to use implants other than the device under investigation
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany4 sites
Berufsgenossenschaftliche Unfallklinik Frankfurt am Main
Frankfurt, 60389
Universitaetsklinikum Heidelberg
Heidelberg, 69118
University of Saarland
Homburg/Saar, 66421
Klinikum der Johannes Gutenberg Universitaet Mainz
Mainz, 55131
About this study
Official title: A Prospective and Retrospective Multicenter Registry for Surgeon-based Evaluation of the "Quadrilateral Surface Plate" Used for Acetabular Fractures
The absence of methodologically, prospectively and retrospectively collected information on the use of the Quadrilateral Surface Plate (QSP) in the given indication requires a multicenter approach. Using a registry to get more information about the effectiveness and possible benefits or complications during the surgery and during the post-operative treatment is adequate and necessary to get new insights to the use of the Quadrilateral Surface Plate.
Read the detailed description
This registry includes six visits at which data is collected form the patinet (pre-op, post-op, 6 weeks FU, 3 months FU, 6 months FU and 12 months FU). Patients can be inlucded prospectively or retrospectively. If properatively recruited patients complete two questionnaires (EQ5D and Merle d'Aubigné) at their preoperative visits. These questionnaires are repeated after 6 and 12 months. Surgeons report about the success of the surgical procedure in a specifically designed questionnaire.
During the whole study period, adverse events related to the implant or surgery are collected as well as x-rays and CT (as per standard of care).
- Conditions
- Acetabular Fracture
- Being tested
- Quadrilateral Surface Plate
- Keywords
- Adverse events, Osteosynthesis, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrilateral Surface PlateDevice
Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients undergoing osteosynthesis of acetabular fractures by using the Quadrilateral Surface Plate Receives: Device: Quadrilateral Surface Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical treatment-related Adverse Events
Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture.
Measured: Intra-operative
Secondary outcomes (8)
Changes in Quality of Life
Changes in Quality of Life, pain and mobility using questionnaires (EQ-5D and Merle d'Aubigné score)
Measured: Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative
Fracture Healing
Fracture healing: defined as a fracture radiographically showing at least three cortices with signs of callus or trabeculae crossing from one side of the fracture to the other.
Measured: Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative
Surgical treatment-related Adverse Events till discharge
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:
- 1-12 days postoperative (till discharge)
Measured: post-operative
Surgical treatment-related Adverse Events till 6 weeks
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:
- 6 weeks postoperative
Measured: post-operative
Surgical treatment-related Adverse Events till 3 months
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:
- 3 months postoperative
Measured: post-operative
Surgical treatment-related Adverse Events till 6 months
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:
- 6 months postoperative
Measured: post-operative
Surgical treatment-related Adverse Events till 12 months
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:
- 12 months postoperative
Measured: post-operative
Surgical treatment-related Adverse Events till 24 months
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:
- 24 months postoperative
Measured: post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2017
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular FractureStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Pohlemann, Prof. MD, Principal investigator, AO foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839565
- Sponsor's protocol ID
- FR_QSP
- Status last verified
- Aug 2020
- First submitted
- 12 Apr 2013
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Retrospective Multicenter Registry for Surgeon-based Evaluation of the "Quadrilateral Surface Plate" Used for Acetabular Fractures
- ClinicalTrials.gov ID
- NCT01839565
- Acronym / sponsor ID
- FR_QSP
- Conditions
- Acetabular Fracture
- Keywords
- Adverse events, Osteosynthesis, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 25 Apr 2013 (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 absence of methodologically, prospectively and retrospectively collected information on the use of the Quadrilateral Surface Plate (QSP) in the given indication requires a multicenter approach. Using a registry to get more information about the effectiveness and possible benefits or complications during the surgery and during the post-operative treatment is adequate and necessary to get new insights to the use of the Quadrilateral Surface Plate.
Detailed description
This registry includes six visits at which data is collected form the patinet (pre-op, post-op, 6 weeks FU, 3 months FU, 6 months FU and 12 months FU). Patients can be inlucded prospectively or retrospectively. If properatively recruited patients complete two questionnaires (EQ5D and Merle d'Aubigné) at their preoperative visits. These questionnaires are repeated after 6 and 12 months. Surgeons report about the success of the surgical procedure in a specifically designed questionnaire.
During the whole study period, adverse events related to the implant or surgery are collected as well as x-rays and CT (as per standard of care).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: Quadrilateral Surface PlatePatients undergoing osteosynthesis of acetabular fractures by using the Quadrilateral Surface Plate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The increasing number of acetabular fractures in elderly individuals with osteoporosis has added new technical challenges to surgical management. A common group of fracture patterns in this population is the anterior wall or column often with an associated posterior hemitransverse. These injuries frequently also include quadrilateral surface comminution which can make both reduction and stabilization more difficult. The 3.5 mm quadrilateral surface plate was developed to provide a more effective way to deal with these issues, for example, a way to deal with the quadrilateral surface enbloc for reduction, allowing buttress stabilization, which is independent of bone density.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Diagnosis of acetabular fracture requiring surgical fixation
- Ability to understand the content of the patient information / informed consent form
- Signed and dated IRB/EC-approved written informed consent
Key exclusion criteria (6 listed)
- Any not medically managed severe systemic disease
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- Prisoner
- Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry
- Intraoperative decision to use implants other than the device under investigation
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 |
|---|---|---|
| Quadrilateral Surface PlatePatients with acetabular fracture surgically treated using the Quadrilateral Surface Plate | Device | Patients |
Primary outcome
Surgical treatment-related Adverse Events
Time frame: Intra-operative
Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture.
8 secondary outcomes
Changes in Quality of Life
Time frame: Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative
Fracture Healing
Time frame: Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative
Surgical treatment-related Adverse Events till discharge
Time frame: post-operative
Surgical treatment-related Adverse Events till 6 weeks
Time frame: post-operative
Surgical treatment-related Adverse Events till 3 months
Time frame: post-operative
Surgical treatment-related Adverse Events till 6 months
Time frame: post-operative
Surgical treatment-related Adverse Events till 12 months
Time frame: post-operative
Surgical treatment-related Adverse Events till 24 months
Time frame: post-operative
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 13 Aug 2020.
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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.
Tim Pohlemann, Prof. MD principal investigator
AO foundation
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetabular Fracture, run by AO Clinical Investigation and Publishing Documentation at 6 sites in 3 countries.
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 4 inclusion and 6 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Italy, 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?
Surgical treatment-related Adverse Events (time frame: Intra-operative). 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 13 Aug 2020.