Orthopedic FracturesPhase 1NCT00823251
IlluminOss Hand Fracture International Clinical Feasibility Study
A Phase 1 study testing IlluminOss device in people with Orthopedic Fractures, run by IlluminOss Medical, Inc. at 1 site in Chile.
Trial summary
The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopedic Fractures
- What is being tested?
- IlluminOss device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChile
- Study dates
- Dec 2008to Feb 2013
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature
- Patient or his/her legal guardian understands the nature of the procedure and is willing to comply with associated follow-up evaluations, and provides written informed consent prior to the procedure
- Female patients must be of non-child bearing potential, or have a negative pregnancy test within prior 48 hours
- Acute fracture of metacarpal or phalangeal bone(s) that requires reduction and internal fixation
- Fracture has occurred within past 3 weeks
- Fracture types: transverse, short oblique, or any fracture pattern in which the comminuted segment is equal to or less than the diameter of the bone at fracture site
Who cannot join
- Patient is pregnant, lactating or female patients who intend to become pregnant during the course of the study
- Patient has experienced a crush, mangling, or burn type injury
- Patient has probable history of infection or confirmed infection at baseline
- Patient has previous diagnosis of a significant bone disorder that may impair bone healing
- Patient has a life expectancy of < 26 weeks
- Pathological fracture secondary to tumor
- Open fracture of Gustilo-Anderson Type II or III
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IlluminOss Medical- Photodynamic Bone Stabilization System- International Study
The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand.
- Conditions
- Orthopedic Fractures
- Being tested
- IlluminOss device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlluminOss deviceDevice
The IlluminOss™ Bone Stabilization System is designed to deliver the device to the fracture site via the medullary canal of the bone using percutaneous techniques. Once the device is in place and has spanned the fracture site, the device is expanded and hardened to reduce and stabilize the fracture, to aid in the support and healing of the bone fracture by primary callous formation and remodeling.
| Study group | Role | What they receive |
|---|---|---|
| IlluminOss device | Experimental | IlluminOss bone-pin device Receives: Device: IlluminOss device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.
Measured: Immediately post-surgery
Secondary outcomes (8)
Rate of Fracture Union
Measured: 180 day
Rate of Anatomic Alignment
Measured: 180 Day
Functionality Score
Measured: 180 Day
Grip Strength
Measured: 180 Day
Range of Motion
Measured: 180 day
Incidence of Reintervention of Target Fracture
Measured: 180 Day
Bone Pin Migration
Measured: 180 Day
Adverse Event Rate
Measured: 180 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlluminOss Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823251
- Sponsor's protocol ID
- ILLUM-OUS-2008-001
- Status last verified
- Jun 2017
- First submitted
- 30 Dec 2008
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IlluminOss Medical- Photodynamic Bone Stabilization System- International Study
- ClinicalTrials.gov ID
- NCT00823251
- Acronym / sponsor ID
- ILLUM-OUS-2008-001
- Conditions
- Orthopedic Fractures
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- IlluminOss Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Jan 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 purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IlluminOss device | Experimental | Device: IlluminOss deviceIlluminOss bone-pin device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Skeletally mature
- Patient or his/her legal guardian understands the nature of the procedure and is willing to comply with associated follow-up evaluations, and provides written informed consent prior to the procedure
- Female patients must be of non-child bearing potential, or have a negative pregnancy test within prior 48 hours
- Acute fracture of metacarpal or phalangeal bone(s) that requires reduction and internal fixation
- Fracture has occurred within past 3 weeks
Key exclusion criteria (7 listed)
- Patient is pregnant, lactating or female patients who intend to become pregnant during the course of the study
- Patient has experienced a crush, mangling, or burn type injury
- Patient has probable history of infection or confirmed infection at baseline
- Patient has previous diagnosis of a significant bone disorder that may impair bone healing
- Patient has a life expectancy of < 26 weeks
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 |
|---|---|---|
| IlluminOss deviceThe IlluminOss™ Bone Stabilization System is designed to deliver the device to the fracture site via the medullary canal of the bone using percutaneous techniques. Once the device is in place and has spanned the fracture site, the device is expanded and hardened to reduce and stabilize the fracture, to aid in the support and healing of the bone fracture by primary callous formation and remodeling. | Device | IlluminOss device |
Primary outcome
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.
Time frame: Immediately post-surgery
8 secondary outcomes
Rate of Fracture Union
Time frame: 180 day
Rate of Anatomic Alignment
Time frame: 180 Day
Functionality Score
Time frame: 180 Day
Grip Strength
Time frame: 180 Day
Range of Motion
Time frame: 180 day
Incidence of Reintervention of Target Fracture
Time frame: 180 Day
Bone Pin Migration
Time frame: 180 Day
Adverse Event Rate
Time frame: 180 day
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 7 Jun 2017.
Related trials for Orthopedic Fractures
Recruiting
Trial of Social Work Services in Fracture Clinic Setting
Orthopaedic Fractures, Socioeconomic Factors
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Not yet recruiting
Nerve Block Resolution Time Display and Pain Complaints
Postoperative Pain, Rebound Pain
Recruiting
Assessment of the Rehabilitative Effects of Curved-walking Training in Stroke, Parkinson and Orthopaedic Populations
Stroke, Acute, Parkinson Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IlluminOss device in people with Orthopedic Fractures, run by IlluminOss Medical, Inc. at 1 site in Chile.
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: finished, as of the sponsor's last update on 7 Jun 2017. 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 Chile. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location. (time frame: Immediately post-surgery). 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 Jun 2017.