Aspiration for Pain Relief Following Ankle Fracture

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stephen A. Sems, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01484535
First received: November 30, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

This trial will study the effect of hematoma aspiration in patients with acute ankle fractures.


Condition Intervention
Ankle Fracture
Procedure: Ankle Aspiration
Procedure: Ankle aspiration Standard Anterolateral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Aspiration for Pain Relief Following Ankle Fracture: A Prospective Double-Blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    NRS scores after 72 hours through 6 months. 6 month SMFA scores. 6 month Olerud Molander scores.


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ankle aspiration
ankle aspiration
Procedure: Ankle Aspiration
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.
Placebo Comparator: placebo procedure
placebo procedure
Procedure: Ankle aspiration Standard Anterolateral
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484535

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Stephen Sems, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Stephen A. Sems, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01484535     History of Changes
Other Study ID Numbers: 11-004187
Study First Received: November 30, 2011
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014