Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment

Fracture of Clavicle Clinical Trial

Official title:

CLAVICLE FRACTURE OUTCOMES: 1-3 YEAR FOLLOW UP OF DISPLACED MIDSHAFT FRACTURES TREATED WITH INTRAMEDULARY NAIL vs. NONOPERATIVE TREATMENT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01975467
• Other study ID #: CRx-001
• Status: Terminated
• Phase: N/A
• First received: October 23, 2013
• Last updated: April 12, 2015
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Sonoma Orthopedic Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Sponsor
• Study type: Observational

Clinical Trial Summary

The objective of this post-market clinical study is to compare one to three year post treatment results, range of motion, strength, patient related functional outcomes and patient satisfaction, of internal fixation using the Sonoma Orthopedic Products CRx™ as compared to nonoperative management (e.g. sling) of similar displaced midshaft clavicle fractures.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A displaced transverse or oblique midshaft clavicle fracture with or without comminution

• Must be 12 ± 2 months to 36 ± 2 months post-treatment

• Must have received nonoperative treatment or operative treatment with a CRx™ device, no other devices, for their clavicle fracture

• Male or female at least 18 years of age

• Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol

• Ability to understand and provide written authorization for use and disclosure of personal health information

Exclusion Criteria:

• Open, or segmental clavicle fracture

• Any clavicle or upper extremity fracture previous, concurrent, or subsequent to the study fracture

• Removal of the CRx™ device within 8 weeks of the study visit

• History of alcoholism

• Currently on chemotherapy or radiation therapy

• Habitual use of narcotic pain medications prior to injury or after injury for reasons other than clavicle pain

• Currently on worker's compensation

• History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis

• Rheumatoid arthritis or other inflammatory arthropathies.

• History of chronic pain issues for reasons other than clavicle pain or psychiatric disorder that precludes reliable follow-up.

• Women that are pregnant or think that they might be pregnant

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fracture of Clavicle
• Fractures, Bone

Intervention

Device:
• CRx
The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.

Locations

Country	Name	City	State
United States	North Coast Orthopaedics and Sports Medicine	Arcata	California
United States	Madison Center/Polyclinic	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Sonoma Orthopedic Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH Score	Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.	One time point	No
Secondary	Range of Motion and Strength	The ASES instrument will be used to assess range of motion and strength.	One time point	No