FracturePhase 4NCT00969839
NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures
A Phase 4 study testing NovaLign Intramedullary Fixation System in people with Fracture, run by NovaLign Orthopaedics, Inc at 2 sites in United States.
Trial summary
This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture
- What is being tested?
- NovaLign Intramedullary Fixation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Mar 2011
- Phase
- Phase 4
- 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
- Humeral Fracture
- Surgical intervention can be performed within 14 days of injury (injury being Day 0 for this particular criteria)
- Fully functioning contralateral limb (e.g., hand, arm, shoulder)
- Age 18 years or older and skeletally mature
Who cannot join
- Intraarticular fractures or those involving shoulder or elbow of the index arm
- Pathologic fracture (e.g., tumor involvement, osteomalacia, etc.; osteoporosis is not an exclusion)
- Evidence of neurologic injury in the index arm, including compartment syndrome or radial nerve palsy
- Additional upper body injuries (e.g., upper extremity, abdominal, thoracic, neck or head injury) that may affect or inhibit the evaluation of the index or contralateral arm, shoulder, elbow, etc or would not allow the patient to follow or comply with appropriate post-operative regimens
- Any previous bodily injury or surgery that may interfere with function or evaluation of index or contralateral arm, shoulder, elbow, etc.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Missouri - Columbia
Columbia, Missouri, 65212
B Crist, MD, 573-884-0854
L Anderson, RN, (573) 884-0854
- Recruiting
Denver Health Medical Center
Denver, Colorado, 80204
S Morgan, MD, 303-602-3796
A Baron, (303) 602-3796
About this study
Official title: A Study to Evaluate the Safety and Effectiveness of the NovaLign Intramedullary Fixation System for the Treatment of Humeral Diaphysis Fractures
This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.
Read the detailed description
This is an observational, prospective, nonrandomized open label, post-market clinical study, designed to evaluate the use a flexible intramedullary fixation device used in the treatment of fractures of the humerus. This is a multicentre trial.
- Conditions
- Fracture
- Being tested
- NovaLign Intramedullary Fixation System
- Keywords
- Fracture, Humerus, Intramedullary, Fixation
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaLign Intramedullary Fixation SystemDevice
Intramedullary fixation of broken humerus
| Study group | Role | What they receive |
|---|---|---|
| Intramedullary Fixation System | Experimental | Humeral fractures to be treated with the Intramedullary Fixation System Receives: Device: NovaLign Intramedullary Fixation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic union and safety
Measured: 12 months
Secondary outcomes (1)
Function, pain, and quality of life assessments at regular intervals
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 posted1 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaLign Orthopaedics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- B Crist, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969839
- Sponsor's protocol ID
- SP-001
- Status last verified
- Sep 2009
- First submitted
- 30 Aug 2009
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Effectiveness of the NovaLign Intramedullary Fixation System for the Treatment of Humeral Diaphysis Fractures
- ClinicalTrials.gov ID
- NCT00969839
- Acronym / sponsor ID
- SP-001
- Conditions
- Fracture
- Keywords
- Fracture, Humerus, Intramedullary, Fixation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NovaLign Orthopaedics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 1 Sep 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.
This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.
Detailed description
This is an observational, prospective, nonrandomized open label, post-market clinical study, designed to evaluate the use a flexible intramedullary fixation device used in the treatment of fractures of the humerus. This is a multicentre trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intramedullary Fixation System | Experimental | Device: NovaLign Intramedullary Fixation SystemHumeral fractures to be treated with the Intramedullary Fixation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Humeral Fracture
- Surgical intervention can be performed within 14 days of injury (injury being Day 0 for this particular criteria)
- Fully functioning contralateral limb (e.g., hand, arm, shoulder)
- Age 18 years or older and skeletally mature
Key exclusion criteria (5 listed)
- Intraarticular fractures or those involving shoulder or elbow of the index arm
- Pathologic fracture (e.g., tumor involvement, osteomalacia, etc.; osteoporosis is not an exclusion)
- Evidence of neurologic injury in the index arm, including compartment syndrome or radial nerve palsy
- Additional upper body injuries (e.g., upper extremity, abdominal, thoracic, neck or head injury) that may affect or inhibit the evaluation of the index or contralateral arm, shoulder, elbow, etc or would not allow the patient to follow or comply with appropriate post-operative regimens
- Any previous bodily injury or surgery that may interfere with function or evaluation of index or contralateral arm, shoulder, elbow, etc.
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 |
|---|---|---|
| NovaLign Intramedullary Fixation SystemIntramedullary fixation of broken humerus | Device | Intramedullary Fixation System |
Primary outcome
Radiographic union and safety
Time frame: 12 months
1 secondary outcome
Function, pain, and quality of life assessments at regular intervals
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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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.
B Crist, MD principal investigator
University of Missouri-Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NovaLign Intramedullary Fixation System in people with Fracture, run by NovaLign Orthopaedics, 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 5 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 18 Sep 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic union and safety (time frame: 12 months). 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 18 Sep 2009.