Plating Clavicle Fractures

Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00871468

Enrollment

Registered

2009-03-30

Start date

2008-10-31

Completion date

2018-08-31

Last updated

2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clavicle Fracture, Non Union/Malunion

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREsuperior plate

Open reduction internal fixation (ORIF) clavicle with superior plate

PROCEDUREanterior-inferior plate

ORIF clavicle with anterior inferior plate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Less irritation with anterior-inferior plating and less need for hardware removal.	2 years

Secondary

Measure	Time frame
DASH (Disability of Arm, Shoulder and Hand) and constant scores	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026