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Aspiration for Pain Relief Following Ankle Fracture

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Mayo Clinic

Status

Completed

Conditions

Ankle Fracture

Treatments

Procedure: Ankle aspiration Standard Anterolateral
Procedure: Ankle Aspiration

Study type

Interventional

Funder types

Other

Identifiers

NCT01484535
11-004187

Details and patient eligibility

About

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

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

130 participants in 2 patient groups, including a placebo group

Ankle aspiration
Other group
Description:
ankle aspiration
Treatment:
Procedure: Ankle Aspiration
placebo procedure
Placebo Comparator group
Description:
placebo procedure
Treatment:
Procedure: Ankle aspiration Standard Anterolateral

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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