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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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 30, 2011
Last Updated
July 16, 2015
Sponsor
Mayo Clinic
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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

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Aspiration for Pain Relief Following Ankle Fracture

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