Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

U

Unity Health Toronto

Status

Completed

Conditions

Fractures
Clavicle Fracture

Treatments

Procedure: Operative Treatment
Procedure: Non-operative Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT00872105
Distal Clavicle Study

Details and patient eligibility

About

This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.

Enrollment

59 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
  • Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph
  • Fractures within 28 days post injury
  • Provision of informed consent

Exclusion criteria

  • Pathological fractures
  • Non-displaced (cortical contact) distal clavicle fractures
  • Open clavicle fractures
  • Presence of vascular injury
  • Fractures more than 28 days post-injury
  • Limited life expectancy due to significant medical co-morbidity
  • 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)

59 participants in 2 patient groups

Non-operative treatment
Other group
Description:
The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.
Treatment:
Procedure: Non-operative Treatment
Operative treatment
Active Comparator group
Description:
The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.
Treatment:
Procedure: Operative Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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