Clavicle FractureNCT04986553
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates
An observational study of Clavicle Fracture, run by Arthrex, Inc. at 2 sites in United States.
Trial summary
The objective of the registry is to evaluate the continued safety and performance of Arthrex Clavicle Plates used to treat clavicle fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- Arthrex Clavicle Plates
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2021to 30 Jul 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Arthrex Clavicle Plates are intended to be used in the general population for clavicle fractures.
Who may be able to join
- The subject requires surgery using the Arthrex Clavicle Plate for clavicle fracture.
- The subject is 18 years of age or over.
- The subject is not considered a vulnerable subject (i.e., child, pregnant, nursing, prisoner, or ward of the state).
- Subject signed informed consent and is willing and able to comply with all study requirements
Who cannot join
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections, which may retard healing.
- Foreign-body sensitivity.
- Any active infection or blood supply limitations.
- Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
- Subjects that are skeletally immature.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sierra Pacific Orthpaedic CenterMedical Group, Inc
Fresno, California, 93720
Panorama Orthopedics & Spine Center, PC
Golden, Colorado, 80401
About this study
The objective of the registry is to evaluate the continued safety and performance of Arthrex Clavicle Plates used to treat clavicle fractures.
Read the detailed description
To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate the performance imaging of the target area will be evaluated at three months postoperative. Additionally, patient-reported outcomes will be evaluated at three months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS), Veterans Rand 12-Item Health Survey (VR-12), and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES).
- Conditions
- Clavicle Fracture
- Being tested
- Arthrex Clavicle Plates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrex Clavicle PlatesDevice
Arthrex Clavicle Plate for treatment of clavicle fractures
| Study group | Role | What they receive |
|---|---|---|
| 50 subjects, male and female, at least 18 years of age | 50 subjects who are candidates for surgery using the Arthrex Clavicle Plate for treatment of clavicle fractures. Receives: Device: Arthrex Clavicle Plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess a change in Visual Analogue Scale (VAS) survey
Patient reported pain scale 0-10 point scale (0 min,10 max)
Measured: Preoperatively, 3 months, 6 months and 12 months postoperatively
To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring scores up
Measured: Preoperatively, 3 months, 6 months and 12 months postoperatively
To assess a change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points.
Measured: Preoperatively, 3 months, 6 months and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start20 May 2021
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Why it stopped: The study was suspended and terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle FractureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986553
- Sponsor's protocol ID
- AIRR-0005
- Status last verified
- Jan 2024
- First submitted
- 22 Jun 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates
- ClinicalTrials.gov ID
- NCT04986553
- Acronym / sponsor ID
- AIRR-0005
- Conditions
- Clavicle Fracture
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was suspended and terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
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 the registry is to evaluate the continued safety and performance of Arthrex Clavicle Plates used to treat clavicle fractures.
Detailed description
To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate the performance imaging of the target area will be evaluated at three months postoperative. Additionally, patient-reported outcomes will be evaluated at three months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS), Veterans Rand 12-Item Health Survey (VR-12), and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50 subjects, male and female, at least 18 years of age | – | Device: Arthrex Clavicle Plates50 subjects who are candidates for surgery using the Arthrex Clavicle Plate for treatment of clavicle fractures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Arthrex Clavicle Plates are intended to be used in the general population for clavicle fractures.
Key inclusion criteria (4 listed)
- The subject requires surgery using the Arthrex Clavicle Plate for clavicle fracture.
- The subject is 18 years of age or over.
- The subject is not considered a vulnerable subject (i.e., child, pregnant, nursing, prisoner, or ward of the state).
- Subject signed informed consent and is willing and able to comply with all study requirements
Key exclusion criteria (6 listed)
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections, which may retard healing.
- Foreign-body sensitivity.
- Any active infection or blood supply limitations.
- Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
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 |
|---|---|---|
| Arthrex Clavicle PlatesArthrex Clavicle Plate for treatment of clavicle fractures | Device | 50 subjects, male and female, at least 18 years of age |
Primary outcome
To assess a change in Visual Analogue Scale (VAS) survey
Time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Patient reported pain scale 0-10 point scale (0 min,10 max)
To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
Time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring scores up
To assess a change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively
ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Clavicle Fracture, run by Arthrex, 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 1 Feb 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To assess a change in Visual Analogue Scale (VAS) survey (time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively). The study lists 3 primary outcomes in all. 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 1 Feb 2024.