Fracture of ClavicleNCT01975467
Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment
An observational study of Fracture of Clavicle, run by Sonoma Orthopedic Products, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fracture of Clavicle
- What is being tested?
- CRx
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population is open to anyone over the age of 18 that meet the study eligibility criteria.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Coast Orthopaedics and Sports Medicine
Arcata, California, 95521
Madison Center/Polyclinic
Seattle, Washington, 98104
About this study
Official title: CLAVICLE FRACTURE OUTCOMES: 1-3 YEAR FOLLOW UP OF DISPLACED MIDSHAFT FRACTURES TREATED WITH INTRAMEDULARY NAIL vs. NONOPERATIVE TREATMENT
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.
- Conditions
- Fracture of Clavicle
- Being tested
- CRx
- Keywords
- midshaft clavicle fracture, intramedullary nail, sling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRxDevice
Also called Intramedullary Nail
The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH Score
Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.
Measured: One time point
Secondary outcomes (1)
Range of Motion and Strength
The ASES instrument will be used to assess range of motion and strength.
Measured: One time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Low Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fracture of ClavicleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonoma Orthopedic Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John LeBlanc, DO, Principal investigator, North Coast Orthopaedics and Sports MedicineCarl Basamania, MD, Principal investigator, Madison Center/Polyclinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975467
- Sponsor's protocol ID
- CRx-001
- Status last verified
- Nov 2016
- First submitted
- 23 Oct 2013
- Last updated
- 28 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLAVICLE FRACTURE OUTCOMES: 1-3 YEAR FOLLOW UP OF DISPLACED MIDSHAFT FRACTURES TREATED WITH INTRAMEDULARY NAIL vs. NONOPERATIVE TREATMENT
- ClinicalTrials.gov ID
- NCT01975467
- Acronym / sponsor ID
- CRx-001
- Conditions
- Fracture of Clavicle
- Keywords
- midshaft clavicle fracture, intramedullary nail, sling
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low Enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sonoma Orthopedic Products, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Posted 28 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group - Nonoperative | – | –Subjects that were treated with a sling for their displaced midshaft clavicle fracture. |
| Test Group - Intramedullary Nail | – | Device: CRxSubjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is open to anyone over the age of 18 that meet the study eligibility criteria.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRxAlso: Intramedullary NailThe CRx is used to treat mid-shaft, with or without comminution clavicle fractures. | Device | Test Group - Intramedullary Nail |
Primary outcome
DASH Score
Time frame: One time point
Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.
1 secondary outcome
Range of Motion and Strength
Time frame: One time point
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John LeBlanc, DO principal investigator
North Coast Orthopaedics and Sports Medicine
Carl Basamania, MD principal investigator
Madison Center/Polyclinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture of Clavicle, run by Sonoma Orthopedic Products, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH Score (time frame: One time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.