NCT01975467

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

December 28, 2016

Completed
Last Updated

December 28, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

October 23, 2013

Results QC Date

November 1, 2016

Last Update Submit

November 1, 2016

Conditions

Fracture of Clavicle

Keywords

midshaft clavicle fractureintramedullary nailsling

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Range of Motion and Strength

    One time point

Study Arms (2)

Control Group - Nonoperative

Subjects that were treated with a sling for their displaced midshaft clavicle fracture.

Test Group - Intramedullary Nail

Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.

Device: CRx

Interventions

CRxDEVICE

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

Also known as: Intramedullary Nail
Test Group - Intramedullary Nail

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population is open to anyone over the age of 18 that meet the study eligibility criteria.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Coast Orthopaedics and Sports Medicine

Arcata, California, 95521, United States

Location

Madison Center/Polyclinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

Fracture Fixation, Intramedullary

Intervention Hierarchy (Ancestors)

Fracture Fixation, InternalFracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Results Point of Contact

Title
Rick Epstein
Organization
Sonoma Orthopedics
repstein@sonomaorthopedics.com
8479872516

Study Officials

  • John LeBlanc, DO

    North Coast Orthopaedics and Sports Medicine

    PRINCIPAL INVESTIGATOR

  • Carl Basamania, MD

    Madison Center/Polyclinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 4, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 28, 2016

Results First Posted

December 28, 2016

Record last verified: 2016-11

Locations

US(2)