Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
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ClinicalTrials.gov Identifier: NCT00872105 |
Recruitment Status
:
Active, not recruiting
First Posted
: March 31, 2009
Last Update Posted
: November 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clavicle Fracture Fractures | Procedure: Non-operative Treatment Procedure: Operative Treatment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 59 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle |
Study Start Date : | March 2009 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Non-operative treatment
The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.
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Procedure: Non-operative Treatment
Standard protocol for conservative treatment will consist of the implementation of a sling, for clavicular support and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon.
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Active Comparator: Operative treatment
The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.
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Procedure: Operative Treatment
The operating surgeon will determine the positioning of the patient for surgery. ORIF of the distal clavicle fracture will be carried out as follows: Anatomic reduction of the fracture Definitive fixation with a contoured clavicle plate and screws; a AO hook plate; a 3.5 LCDC, reconstruction, or compression plate is acceptable; a 1/3 tubular plate is not acceptable Use of bone graft is optional (iliac crest bone autograft) |
- The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire. [ Time Frame: 2 years ]
- The secondary outcome measurement patients' functional shoulder scores as defined by Constant's Shoulder Score (i.e. pain, activities of daily living, range of motion and power). [ Time Frame: 2 years ]

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Ages Eligible for Study: | 16 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872105
Canada, Ontario | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5C 1R6 |
Principal Investigator: | Jeremy A Hall, MD, FRCS(C) | St. Michael's Hospital, Toronto |
Responsible Party: | St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT00872105 History of Changes |
Other Study ID Numbers: |
Distal Clavicle Study |
First Posted: | March 31, 2009 Key Record Dates |
Last Update Posted: | November 27, 2017 |
Last Verified: | November 2017 |
Keywords provided by St. Michael's Hospital, Toronto:
clavicle fractures distal |
Additional relevant MeSH terms:
Fractures, Bone Wounds and Injuries |