High Energy Midshaft Clavicle FracturesNCT00590850
Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
A study testing ORIF with Plate and Screws and Pin Fixation in people with High Energy Midshaft Clavicle Fractures, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. Some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. There is no evidence to date that either option in superior. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- High Energy Midshaft Clavicle Fractures
- What is being tested?
- ORIF with Plate and Screws and Pin Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages of 18 and 85
- a midshaft clavicle fracture
- fracture displaced the width of the clavicle or shortened at least 1.5 cm
- less than 21 days since the injury
Who cannot join
- injury involving the lateral ligaments
- fracture involve the sternoclavicular joint
- Pathologic Fracture
- Open Fracture
- Fracture with neurovascular compromise
- Displaced fracture with impending skin compromise
Show all 9Show fewer
- Medical comorbidities that preclude surgery
- Associated injuries to ipsilateral shoulder girdle
- severe cognitive disability or injury that may inhibit study form completion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, Randomized Trial of Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. Some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. There is no evidence to date that either option in superior. For this reason, we propose to conduct a prospective, randomized clinical trial of surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This study will use both objective clinical and patient-based outcome measures. The purpose of this study is to see if there is a difference between clinical outcomes (healing rate, time to healing, time to return to work, Constant Score, complications), functional outcomes (DASH Score), and health related quality of life (SF-36) in nonoperative care and two types of surgical care for displaced fractures of the clavicular shaft in adults.
Included patients will be randomized into one of three groups: nonoperative care (Group N); surgical care using plates and screws (Group P); and surgical care using intramedullary pin put inside of the clavicle to stabilize it (Group I).
- Conditions
- High Energy Midshaft Clavicle Fractures
- Being tested
- ORIF with Plate and Screws, Pin Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIF with Plate and ScrewsProcedure or surgery
ORIF with plate and screws
Pin FixationProcedure or surgery
Clavicle fixation with clavicle pin
| Study group | Role | What they receive |
|---|---|---|
| Closed | No intervention | Closed Treatment |
| ORIF | Active comparator | Open Reduction and Internal Fixation (ORIF) with Plate and Screws Receives: Procedure: ORIF with Plate and Screws |
| Pin | Active comparator | Pin Fixation Receives: Procedure: Pin Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability of Arm, Shoulder and Hand (DASH) scores
Disability of Arm, Shoulder and Hand (DASH) scores
Measured: 1 year
Secondary outcomes (1)
Reoperation rate
rate of reoperations between groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startOct 2003
- Primary completionDec 2020
- Study completionOct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Energy Midshaft Clavicle FracturesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association, Indiana University
- Responsible party
- Sponsor
- Investigators
- Kyle J Jeray, MD, Principal investigator, Greenville Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590850
- Sponsor's protocol ID
- GHS-07-03-04
- Status last verified
- Mar 2023
- First submitted
- 28 Dec 2007
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeray KJ, Broderick JS, Mullis BH, Everhart J, Tanner SL, Snider BG; Southeastern Fracture Consortium. Multicenter, Prospective, Observational Study of Nonoperative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures. J Orthop Trauma. 2024 Jul 1;38(7):345-350. doi: 10.1097/BOT.0000000000002817.
PubMed 38837208
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Trial of Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
- ClinicalTrials.gov ID
- NCT00590850
- Acronym / sponsor ID
- GHS-07-03-04
- Conditions
- High Energy Midshaft Clavicle Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association, Indiana University
- Study start
- Oct 2003
- Primary completion
- Dec 2020 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 11 Jan 2008 (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.
Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. Some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. There is no evidence to date that either option in superior. For this reason, we propose to conduct a prospective, randomized clinical trial of surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This study will use both objective clinical and patient-based outcome measures. The purpose of this study is to see if there is a difference between clinical outcomes (healing rate, time to healing, time to return to work, Constant Score, complications), functional outcomes (DASH Score), and health related quality of life (SF-36) in nonoperative care and two types of surgical care for displaced fractures of the clavicular shaft in adults.
Included patients will be randomized into one of three groups: nonoperative care (Group N); surgical care using plates and screws (Group P); and surgical care using intramedullary pin put inside of the clavicle to stabilize it (Group I).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Closed | No intervention | –Closed Treatment |
| ORIF | Active comparator | Procedure: ORIF with Plate and ScrewsOpen Reduction and Internal Fixation (ORIF) with Plate and Screws |
| Pin | Active comparator | Procedure: Pin FixationPin Fixation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ages of 18 and 85
- a midshaft clavicle fracture
- fracture displaced the width of the clavicle or shortened at least 1.5 cm
- less than 21 days since the injury
Key exclusion criteria (9 listed)
- injury involving the lateral ligaments
- fracture involve the sternoclavicular joint
- Pathologic Fracture
- Open Fracture
- Fracture with neurovascular compromise
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 |
|---|---|---|
| ORIF with Plate and ScrewsORIF with plate and screws | Procedure or surgery | ORIF |
| Pin FixationClavicle fixation with clavicle pin | Procedure or surgery | Pin |
Primary outcome
Disability of Arm, Shoulder and Hand (DASH) scores
Time frame: 1 year
Disability of Arm, Shoulder and Hand (DASH) scores
1 secondary outcome
Reoperation rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Derived from this study: PubMed 38837208Jeray KJ, Broderick JS, Mullis BH, Everhart J, Tanner SL, Snider BG; Southeastern Fracture Consortium. Multicenter, Prospective, Observational Study of Nonoperative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures. J Orthop Trauma. 2024 Jul 1;38(7):345-350. doi: 10.1097/BOT.0000000000002817.
- Individual participant dataSharing planned: No
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.
Kyle J Jeray, MD principal investigator
Greenville Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORIF with Plate and Screws and Pin Fixation in people with High Energy Midshaft Clavicle Fractures, run by Prisma Health-Upstate at 1 site 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 9 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: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disability of Arm, Shoulder and Hand (DASH) scores (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00590850, which also lists 1 linked publication.
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 15 Nov 2023.