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Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

U

Unity Health Toronto

Status

Completed

Conditions

Humeral Fractures
Ulnar Nerve Compression

Treatments

Procedure: anterior subcutaneous transposition
Procedure: Simple decompression

Study type

Interventional

Funder types

Other

Identifiers

NCT01051869
Ulnar Nerve 06-Jan-10

Details and patient eligibility

About

Both simple decompression and anterior transposition of the elbow nerve (ulnar nerve) for acute displaced fractures of the elbow (distal humerus) treated with plate fixation are currently used by surgeons. We want to examine which treatment will overall give better results in regards to arm function and residual pain.

Enrollment

56 patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men or women aged 16 to 60 years of age
  • Displaced, distal humerus fracture (OTA 13A or 13C) as seen in radiographs
  • Fractures ≤ 28 days post injury
  • Closed fractures
  • No history of previous ulnar neuropathy or elbow pathology
  • Provisin of informed consent

Exclusion criteria

  • Vascular injury
  • History of previous ulnar neuropathy or elbow pathology
  • Fractures more than 28 days post-injury
  • Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery
  • Inability to comply with rehabilitation or form completion
  • Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 2 patient groups

simple decompression
Active Comparator group
Treatment:
Procedure: Simple decompression
anterior subcutaneous transposition
Active Comparator group
Treatment:
Procedure: anterior subcutaneous transposition

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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