Ankle FracturesNCT04033848
AORIF Complex Ankle Fractures
An observational study of Ankle Fractures, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The aim of this study is to evaluate the intraarticular lesions, to identify fractures specifically at risk for these, and to assess the results following arthroscopically assisted open reduction and internal fixation of complex ankle fractures prospectively. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Arthroscopic assisted ankle fracture treatment
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2013to May 2021
- How long will I take part?
- 10 Years
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient are being recruted from the investigator's ER or foot and ankle outpatient deparment
Who may be able to join
- Unimalleolar fracture + ligamentous injury
- Bi- or trimalleolar fracture ± ligamentous injury
- > 17 years
- Date of injury less than 15 days
- Written informed consent
Who cannot join
- Isolated unimalleolar fracture
- Pilon fracture
- Open fracture
- Mental illness, incompliance, pregnancy
- Multiple injuries
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Trauma Surgery, Medical University of Munich
Munich, 80336
Sebastian F. Baumbach, M.D., sebastian.baumbach@med.uni-muenchen.de
Sebastian F. Baumbach, M.D.
About this study
Official title: Arthroscopically Assisted Treatment of Complex Ankle Fractures - Intraarticular Findings and Prospective PROM Follow-Up
The aim of this study is to evaluate the intraarticular lesions, to identify fractures specifically at risk for these, and to assess the results following arthroscopically assisted open reduction and internal fixation of complex ankle fractures prospectively.
Read the detailed description
Starting 05/01/13 patients with complex ankle fractures, older than 17 years, who sustained the injury less than 14 days before surgery and giving informed consent are consecutively enrolled. A complex fracture is defined as either an isolated malleolar fracture in combination with ligamentous instability, or a bi- or trimalleolar fracture. An unstable ligamentous injury is defined as either a disruption of the deltoid ligament leading to increased medial talar tilt, or an unstable syndesmotic injury assessed by the external rotation test both after osteosynthesis of all fractures. Exclusion criteria are isolated unimalleolar fractures, pilon fractures, open fractures, multiple injuries, mental illness, incompliance or pregnancy.
Data assessed are:
- Demographics
- Medical history
- Classification (AO, Haraguchi, ICRS, location and size defect)
- Surgery details
- Complications
- PROMs (FAAM, AOFAS, OMAS, FAOS, TAS, SF-12, EQ-5d, MoxFQ)
- Conditions
- Ankle Fractures
- Being tested
- Arthroscopic assisted ankle fracture treatment
- Keywords
- Arthroscopy, Ankle Fracture, Patient rated outcome
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic assisted ankle fracture treatmentProcedure or surgery
Any complex ankle fracture, as discriped above, will be treated arthroscopically and will be prospectively followed-up using well validated PROMs
What is being measured
The primary outcome is the main question the study is designed to answer.
OMAS
Olerud and Molander Ankle Score; Validated PROM; Range 0-100
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
ICRS: Clinical Cartilage Injury Evaluation System
Intraarticular cartilage lesions and treatment
Measured: IntraOP
FAAM
Foot and Ankle Ability Measure, Validated PROM; Range 0-100
Measured: Through study completion, an average of 1 year
AOFAS
American Orthopaedic Foot and Ankle Society, Validated PROM; Range 0-100
Measured: Through study completion, an average of 1 year
FAOS
Foot and Ankle Outcome Score, Validated PROM; Range 0-100
Measured: Through study completion, an average of 1 year
TAS
Tegener Activity Scale, Validated PROM; Range 0-10
Measured: Through study completion, an average of 1 year
SF-12
Quality of life score, Validated PROM; Range 0-100
Measured: Through study completion, an average of 1 year
EQ-5d
Quality of life score, Validated PROM; Range 0-100
Measured: Through study completion, an average of 1 year
MoxFQ
The Manchester-Oxford Foot Questionnaire, Validated PROM; Range 0-100
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 May 2013
- Primary completionMay 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian. F. Baumbach, Ludwig-Maximilians - University of Munich
- Investigators
- Wolfgang Böcker, MD, Study chair, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033848
- Sponsor's protocol ID
- AZ 117-15
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared on reasonable demand / colaboration
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopically Assisted Treatment of Complex Ankle Fractures - Intraarticular Findings and Prospective PROM Follow-Up
- ClinicalTrials.gov ID
- NCT04033848
- Acronym / sponsor ID
- AZ 117-15
- Conditions
- Ankle Fractures
- Keywords
- Arthroscopy, Ankle Fracture, Patient rated outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 26 Jul 2019 (actual)
- 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 aim of this study is to evaluate the intraarticular lesions, to identify fractures specifically at risk for these, and to assess the results following arthroscopically assisted open reduction and internal fixation of complex ankle fractures prospectively.
Detailed description
Starting 05/01/13 patients with complex ankle fractures, older than 17 years, who sustained the injury less than 14 days before surgery and giving informed consent are consecutively enrolled. A complex fracture is defined as either an isolated malleolar fracture in combination with ligamentous instability, or a bi- or trimalleolar fracture. An unstable ligamentous injury is defined as either a disruption of the deltoid ligament leading to increased medial talar tilt, or an unstable syndesmotic injury assessed by the external rotation test both after osteosynthesis of all fractures. Exclusion criteria are isolated unimalleolar fractures, pilon fractures, open fractures, multiple injuries, mental illness, incompliance or pregnancy.
Data assessed are:
- Demographics
- Medical history
- Classification (AO, Haraguchi, ICRS, location and size defect)
- Surgery details
- Complications
- PROMs (FAAM, AOFAS, OMAS, FAOS, TAS, SF-12, EQ-5d, MoxFQ)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient are being recruted from the investigator's ER or foot and ankle outpatient deparment
Key inclusion criteria (5 listed)
- Unimalleolar fracture + ligamentous injury
- Bi- or trimalleolar fracture ± ligamentous injury
- > 17 years
- Date of injury less than 15 days
- Written informed consent
Key exclusion criteria (5 listed)
- Isolated unimalleolar fracture
- Pilon fracture
- Open fracture
- Mental illness, incompliance, pregnancy
- Multiple injuries
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 |
|---|---|---|
| Arthroscopic assisted ankle fracture treatmentAny complex ankle fracture, as discriped above, will be treated arthroscopically and will be prospectively followed-up using well validated PROMs | Procedure or surgery | – |
Primary outcome
OMAS
Time frame: Through study completion, an average of 1 year
Olerud and Molander Ankle Score; Validated PROM; Range 0-100
8 secondary outcomes
ICRS: Clinical Cartilage Injury Evaluation System
Time frame: IntraOP
FAAM
Time frame: Through study completion, an average of 1 year
AOFAS
Time frame: Through study completion, an average of 1 year
FAOS
Time frame: Through study completion, an average of 1 year
TAS
Time frame: Through study completion, an average of 1 year
SF-12
Time frame: Through study completion, an average of 1 year
EQ-5d
Time frame: Through study completion, an average of 1 year
MoxFQ
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: Undecided. Data will be shared on reasonable demand / colaboration
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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.
Wolfgang Böcker, MD study chair
LMU Munich
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 Ankle Fractures, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 26 Jul 2019. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian F Baumbach, MD (0049894400 ext. 519474, sebastian.baumbach@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OMAS (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?
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 26 Jul 2019.