Humeral FracturesNCT02861495
Humeral Compression/Distraction Device
A study testing Humeral Compression/Distraction (CD) Nail in people with Humeral Fractures, run by Florida Orthopaedic Institute at 1 site in United States.
Trial summary
The proposed study of humeral shaft fractures in adults will examine outcomes in patients treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions, or malunions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- Humeral Compression/Distraction (CD) Nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2016to 15 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult skeletally mature patients 18 years or older, treated by the Orthopaedic Trauma Service at Tampa General Hospital, and the Trauma Service at St. Louis University Hospital
- Open or closed displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions or malunions
- amenable to treatment with an intramedullary nail
Who cannot join
- Intra-articular extension of the fracture, prohibiting treatment with an intramedullary nail;
- Pathologic fracture
- Retained hardware
- Patients with pacemakers
- Age under 18 years.
- Patients who are prisoners or likely to become prisoners
Show all 10Show fewer
- Homeless, or those likely to have difficulty making follow-up appointments
- Pregnancy
- Ipsilateral nerve or vascular injuries
- Immunocompromised patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Humeral Compression/Distraction (CD) Device Used for Fixation of Humeral Fractures
The proposed study of humeral shaft fractures in adults will examine outcomes in patients treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an internal gear system controlled wirelessly by rare earth magnets, which typically offers distraction for lengthening. In the humerus however, during the treatment of acute fractures, this percutaneously inserted nail can also offer compression during the healing process, thereby negating the effect of gravity, which may in turn lead to a faster and more consistent rate of union. Furthermore, in cases of slower healing the dynamic properties of the nail may employ an "accordion technique" (alternating compression-distraction, a feature unique to this implant.
Read the detailed description
The primary end point will be the union rate without secondary procedures. The hypothesis is that with the compression and distraction that this device makes possible, the investigators can achieve a higher union rate than with other forms of treatment, using a percutaneous approach, with a decreased complication rate, and can dynamically modulate the healing response when needed. The primary safety endpoint is the occurrence of adverse events from the time of treatment.
During the healing process an external remote controller (ERC) will be used to continually compress or distract the fracture as needed. The surgeon will monitor healing and decide, clinically based on sequential radiographs during subsequent office visits, whether the fracture needs additional compression or distraction, an accordion technique, or no additional external manipulation via the ERC. Participants will be followed for 12 months.
- Conditions
- Humeral Fractures
- Being tested
- Humeral Compression/Distraction (CD) Nail
- Keywords
- upper extremity fracture
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humeral Compression/Distraction (CD) NailDevice
Surgical fixation of humeral shaft fractures with Humeral Compression/Distraction (CD) Nail implant
| Study group | Role | What they receive |
|---|---|---|
| humeral nail | Experimental | Surgical fixation with a humeral compression/distraction nail. Receives: Device: Humeral Compression/Distraction (CD) Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union rate
Union rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.
Measured: 3 months post operatively
Secondary outcomes (2)
Complication rate
Complication rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.
Measured: 12 months
Adverse Events
Adverse event rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start30 Sep 2016
- Primary completion9 Aug 2018
- Study completion15 Aug 2018
Why it stopped: Study stopped due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Orthopaedic Institute
- Sponsor type
- Research network
- Collaborators
- NuVasive, St. Louis University
- Responsible party
- Sponsor
- Investigators
- Roy W Sanders, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861495
- Sponsor's protocol ID
- 2001
- Status last verified
- Sep 2018
- First submitted
- 3 Aug 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humeral Compression/Distraction (CD) Device Used for Fixation of Humeral Fractures
- ClinicalTrials.gov ID
- NCT02861495
- Acronym / sponsor ID
- 2001
- Conditions
- Humeral Fractures
- Keywords
- upper extremity fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to low enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Florida Orthopaedic InstituteResearch network
- Collaborators
- NuVasive, St. Louis University
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 10 Aug 2016 (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 proposed study of humeral shaft fractures in adults will examine outcomes in patients treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an internal gear system controlled wirelessly by rare earth magnets, which typically offers distraction for lengthening. In the humerus however, during the treatment of acute fractures, this percutaneously inserted nail can also offer compression during the healing process, thereby negating the effect of gravity, which may in turn lead to a faster and more consistent rate of union. Furthermore, in cases of slower healing the dynamic properties of the nail may employ an "accordion technique" (alternating compression-distraction, a feature unique to this implant.
Detailed description
The primary end point will be the union rate without secondary procedures. The hypothesis is that with the compression and distraction that this device makes possible, the investigators can achieve a higher union rate than with other forms of treatment, using a percutaneous approach, with a decreased complication rate, and can dynamically modulate the healing response when needed. The primary safety endpoint is the occurrence of adverse events from the time of treatment.
During the healing process an external remote controller (ERC) will be used to continually compress or distract the fracture as needed. The surgeon will monitor healing and decide, clinically based on sequential radiographs during subsequent office visits, whether the fracture needs additional compression or distraction, an accordion technique, or no additional external manipulation via the ERC. Participants will be followed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| humeral nail | Experimental | Device: Humeral Compression/Distraction (CD) NailSurgical fixation with a humeral compression/distraction nail. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult skeletally mature patients 18 years or older, treated by the Orthopaedic Trauma Service at Tampa General Hospital, and the Trauma Service at St. Louis University Hospital
Key exclusion criteria (10 listed)
- Intra-articular extension of the fracture, prohibiting treatment with an intramedullary nail;
- Pathologic fracture
- Retained hardware
- Patients with pacemakers
- Age under 18 years.
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 |
|---|---|---|
| Humeral Compression/Distraction (CD) NailSurgical fixation of humeral shaft fractures with Humeral Compression/Distraction (CD) Nail implant | Device | humeral nail |
Primary outcome
Union rate
Time frame: 3 months post operatively
Union rate for compression/distraction nail will be compared to retrospective cohort of surgical fixation with humeral plates.
2 secondary outcomes
Complication rate
Time frame: 12 months
Adverse Events
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study stopped due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No. There is no plan to share data at this time.
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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.
Roy W Sanders, MD principal investigator
Florida Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humeral Compression/Distraction (CD) Nail in people with Humeral Fractures, run by Florida Orthopaedic Institute 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 3 inclusion and 10 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 7 Sep 2018. 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 was stopped early (reason given: Study stopped due to low enrollment.). 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?
Union rate (time frame: 3 months post operatively). 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 7 Sep 2018.