Plating Clavicle Fractures

U

United States Army Institute of Surgical Research

Status

Unknown

Conditions

Clavicle Fracture, Non Union/Malunion

Treatments

Procedure: anterior-inferior plate
Procedure: superior plate

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00871468
H-08-003

Details and patient eligibility

About

The anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.

Full description

Compare the rates of soft-tissue irritation with two different methods of plating for clavicle fractures. Patients will be randomized to anterior-inferior or superior plating. Validated shoulder scoring systems will be used to assess outcome. Specific follow-up questions will address the patient's ability to wear his/her uniform, body armor, ruck sack, and other shoulder-borne equipment over the surgical site.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Active duty, Reservists, National Guard service members
  • completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments)
  • a fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment)
  • chronic nonunion and malunion fractures
  • no medical contraindications to general anesthesia
  • provided informed consent.

Exclusion criteria

  • an age of less than eighteen years or greater than sixty five years
  • a fracture in the proximal or distal third of the clavicle not amenable to plating
  • a pathological fracture
  • an associated head injury (a Glasgow Coma Scale score of <15 at 21 days after injury)
  • an inability to comply with followup
  • a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy)
  • a lack of consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups

superior plate
Active Comparator group
Description:
Clavicle plate on the superior surface of the bone
Treatment:
Procedure: superior plate
anterior inferior plate
Experimental group
Description:
plate placed on anterior inferior surface of bone
Treatment:
Procedure: anterior-inferior plate

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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