Aspiration for Pain Relief Following Ankle Fracture
Primary Purpose
Ankle Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankle Aspiration
Ankle aspiration Standard Anterolateral
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Fracture
Eligibility Criteria
Inclusion criteria:
- AO/OTA fracture classification 44
- Closed fracture
- Injury within 24 hours of presentation
- Skeletally mature
- Able to provide consent to participate in study
Exclusion Criteria:
- 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Placebo Comparator
Arm Label
Ankle aspiration
placebo procedure
Arm Description
ankle aspiration
placebo procedure
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01484535
Brief Title
Aspiration for Pain Relief Following Ankle Fracture
Official Title
Aspiration for Pain Relief Following Ankle Fracture: A Prospective Double-Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial will study the effect of hematoma aspiration in patients with acute ankle fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ankle aspiration
Arm Type
Other
Arm Description
ankle aspiration
Arm Title
placebo procedure
Arm Type
Placebo Comparator
Arm Description
placebo procedure
Intervention Type
Procedure
Intervention Name(s)
Ankle Aspiration
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ankle aspiration Standard Anterolateral
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Total amount of pain medication used in the first 72 hours from time of initial evaluation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of volumetric increase of the injured ankle compared to the uninjured ankle.
Description
NRS scores after 72 hours through 6 months. 6 month SMFA scores. 6 month Olerud Molander scores.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
AO/OTA fracture classification 44
Closed fracture
Injury within 24 hours of presentation
Skeletally mature
Able to provide consent to participate in study
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Sems, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Aspiration for Pain Relief Following Ankle Fracture
We'll reach out to this number within 24 hrs