Ankle FractureNCT01484535
Aspiration for Pain Relief Following Ankle Fracture
A study testing Ankle Aspiration and Ankle aspiration Standard Anterolateral in people with Ankle Fracture, run by Mayo Clinic at 1 site in United States.
Trial summary
This trial will study the effect of hematoma aspiration in patients with acute ankle fractures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Fracture
- What is being tested?
- Ankle Aspiration and Ankle aspiration Standard Anterolateral
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AO/OTA fracture classification 44
- Closed fracture
- Injury within 24 hours of presentation
- Skeletally mature
- Able to provide consent to participate in study
Who cannot join
- Any concomitant injuries affecting Numerical Rating Scale
- Soft tissue wounds at aspiration sites that compromise ability to aspirate
- Patient not able to complete pain medication log
- Patient not able to participate in follow up
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Aspiration for Pain Relief Following Ankle Fracture: A Prospective Double-Blind Randomized Controlled Trial
This trial will study the effect of hematoma aspiration in patients with acute ankle fractures.
- Conditions
- Ankle Fracture
- Being tested
- Ankle Aspiration, Ankle aspiration Standard Anterolateral
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle AspirationProcedure or surgery
Ankle aspiration will be performed through either a standard anterolateral or anteromedial approach, depending on the conditions of the soft tissue. The anterolateral approach will be the preferred method due to the higher reproducibility of intra-articular needle placement. The anteromedial approach will be reserved for patients whose soft tissues over the anterolateral portal are compromised. Sterile preparation of the limb will be achieved with the use of chlorhexidine or Betadine. An 18 gauge needle will be introduced into the ankle joint and a syringe will be used to aspirate the ankle until no more hemarthrosis is able to be removed. The amount of hemarthrosis aspirated will be recorded. Following the procedure, care will continue as per standard of care.
Ankle aspiration Standard AnterolateralProcedure or surgery
Placebo ankle aspiration will be performed through a standard anterolateral. Sterile preparation of the limb will be achieved with the use of chlorhexidine or Betadine. An 18-gauge needle will be introduced into the skin. The needle will be held in the skin for 5-10 seconds in an effort to simulate the pain and time-lag experienced with aspiration. The needle will not pass the fascia or ankle joint capsule. Following the procedure, care will continue as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Ankle aspiration | Other | ankle aspiration Receives: Procedure: Ankle Aspiration |
| placebo procedure | Placebo comparator | placebo procedure Receives: Procedure: Ankle aspiration Standard Anterolateral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as rated by numerical rating scale (NRS) scores in the emergency department and in the first 72 hours from the time of initial evaluation.
Total amount of pain medication used in the first 72 hours from time of initial evaluation.
Measured: 6 months
Secondary outcomes (1)
Percentage of volumetric increase of the injured ankle compared to the uninjured ankle.
NRS scores after 72 hours through 6 months. 6 month SMFA scores. 6 month Olerud Molander scores.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FractureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen A. Sems, Mayo Clinic
- Investigators
- Stephen Sems, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484535
- Sponsor's protocol ID
- 11-004187
- Status last verified
- Jul 2015
- First submitted
- 30 Nov 2011
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiration for Pain Relief Following Ankle Fracture: A Prospective Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01484535
- Acronym / sponsor ID
- 11-004187
- Conditions
- Ankle Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Dec 2011 (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.
This trial will study the effect of hematoma aspiration in patients with acute ankle fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle aspiration | Other | Procedure: Ankle Aspirationankle aspiration |
| placebo procedure | Placebo comparator | Procedure: Ankle aspiration Standard Anterolateralplacebo procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AO/OTA fracture classification 44
- Closed fracture
- Injury within 24 hours of presentation
- Skeletally mature
- Able to provide consent to participate in study
Key exclusion criteria (4 listed)
- Any concomitant injuries affecting Numerical Rating Scale
- Soft tissue wounds at aspiration sites that compromise ability to aspirate
- Patient not able to complete pain medication log
- Patient not able to participate in follow up
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 |
|---|---|---|
| Ankle AspirationAnkle aspiration will be performed through either a standard anterolateral or anteromedial approach, depending on the conditions of the soft tissue. The anterolateral approach will be the preferred method due to the higher reproducibility of intra-articular needle placement. The anteromedial approach will be reserved for patients whose soft tissues over the anterolateral portal are compromised. Sterile preparation of the limb will be achieved with the use of chlorhexidine or Betadine. An 18 gauge needle will be introduced into the ankle joint and a syringe will be used to aspirate the ankle until no more hemarthrosis is able to be removed. The amount of hemarthrosis aspirated will be recorded. Following the procedure, care will continue as per standard of care. | Procedure or surgery | Ankle aspiration |
| Ankle aspiration Standard AnterolateralPlacebo ankle aspiration will be performed through a standard anterolateral. Sterile preparation of the limb will be achieved with the use of chlorhexidine or Betadine. An 18-gauge needle will be introduced into the skin. The needle will be held in the skin for 5-10 seconds in an effort to simulate the pain and time-lag experienced with aspiration. The needle will not pass the fascia or ankle joint capsule. Following the procedure, care will continue as per standard of care. | Procedure or surgery | placebo procedure |
Primary outcome
Pain as rated by numerical rating scale (NRS) scores in the emergency department and in the first 72 hours from the time of initial evaluation.
Time frame: 6 months
Total amount of pain medication used in the first 72 hours from time of initial evaluation.
1 secondary outcome
Percentage of volumetric increase of the injured ankle compared to the uninjured ankle.
Time frame: 6 months
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 17 Jul 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.
Stephen Sems, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Aspiration and Ankle aspiration Standard Anterolateral in people with Ankle Fracture, run by Mayo Clinic at 1 site in United States.
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 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 17 Jul 2015. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Pain as rated by numerical rating scale (NRS) scores in the emergency department and in the first 72 hours from the time of initial evaluation. (time frame: 6 months). 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 17 Jul 2015.