Clavicle Fracture, Non Union/MalunionNCT00871468
Plating Clavicle Fractures
A study testing superior plate and anterior-inferior plate in people with Clavicle Fracture, Non Union/Malunion, run by United States Army Institute of Surgical Research at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Clavicle Fracture, Non Union/Malunion
- What is being tested?
- superior plate and anterior-inferior plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Aug 2018
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
William Beaumont Army Medical Center
El Paso, Texas, 79920-5001
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
About this study
Official title: Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial
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.
Read the 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.
- Conditions
- Clavicle Fracture, Non Union/Malunion
- Being tested
- superior plate, anterior-inferior plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superior plateProcedure or surgery
Open reduction internal fixation (ORIF) clavicle with superior plate
anterior-inferior plateProcedure or surgery
ORIF clavicle with anterior inferior plate
| Study group | Role | What they receive |
|---|---|---|
| superior plate | Active comparator | Clavicle plate on the superior surface of the bone Receives: Procedure: superior plate |
| anterior inferior plate | Experimental | plate placed on anterior inferior surface of bone Receives: Procedure: anterior-inferior plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Less irritation with anterior-inferior plating and less need for hardware removal.
Measured: 2 years
Secondary outcomes (1)
DASH (Disability of Arm, Shoulder and Hand) and constant scores
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle Fracture, Non Union/MalunionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Collaborators
- William Beaumont Army Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871468
- Sponsor's protocol ID
- H-08-003
- Status last verified
- Dec 2016
- First submitted
- 26 Mar 2009
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00871468
- Acronym / sponsor ID
- H-08-003
- Conditions
- Clavicle Fracture, Non Union/Malunion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Collaborators
- William Beaumont Army Medical Center
- Study start
- Oct 2008
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 30 Mar 2009 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| superior plate | Active comparator | Procedure: superior plateClavicle plate on the superior surface of the bone |
| anterior inferior plate | Experimental | Procedure: anterior-inferior plateplate placed on anterior inferior surface of bone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| superior plateOpen reduction internal fixation (ORIF) clavicle with superior plate | Procedure or surgery | superior plate |
| anterior-inferior plateORIF clavicle with anterior inferior plate | Procedure or surgery | anterior inferior plate |
Primary outcome
Less irritation with anterior-inferior plating and less need for hardware removal.
Time frame: 2 years
1 secondary outcome
DASH (Disability of Arm, Shoulder and Hand) and constant scores
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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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?
A study testing superior plate and anterior-inferior plate in people with Clavicle Fracture, Non Union/Malunion, run by United States Army Institute of Surgical Research 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 7 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: status not confirmed, as of the sponsor's last update on 13 Oct 2017. 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?
Results are not available in the source record.
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?
Less irritation with anterior-inferior plating and less need for hardware removal. (time frame: 2 years). 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 13 Oct 2017; AzTrials last refreshed its copy on 26 Oct 2026.