Aspiration for Pain Relief Following Ankle Fracture

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Stephen A. Sems, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01484535

First received: November 30, 2011

Last updated: February 27, 2013

Last verified: February 2013

History of Changes

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:

MedlinePlus related topics: Fractures

U.S. FDA Resources

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 Primary Completion Date:	December 2013 (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.

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

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:	February 27, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013

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