Non Union Diaphyseal FracturesPhase 4InfuseNCT00856479
A Randomized Controlled Cost Study of Infuse BMP 2 vs Iliac Crest Autograft for Non Union of Long Bone Fractures
A Phase 4 study testing Infuse Bone Morphogenic Protein (BMP) 2 and iliac crest autograft in people with Non Union Diaphyseal Fractures, run by Ross Leighton at 1 site in Canada.
Trial summary
We are inviting individuals such as yourself, who have diaphyseal fracture (broken bone) with a non union to participate in this research study. A non-union is a lack of bone healing (bone growth where the break in the bone occurred) after 3 months after the operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Union Diaphyseal Fractures
- What is being tested?
- Infuse Bone Morphogenic Protein (BMP) 2 and iliac crest autograft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Mar 2013
- 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
- Patients must meet all of the following criteria to be eligible for entry into the study:
- Patients must require open surgical treatment of non-union of a diaphyseal fracture of the tibia, humerus, femur, radius or ulna sustained secondary to trauma.
- Patients must be candidates for surgical treatment with an intramedullary nail or locked or unlocked plate.
- Patients must have a fracture of the diaphysis as defined for that specific bone.
- Patients must show radiographic evidence of skeletal maturity (closed epiphyseal plates).
Who cannot join
- Patients with any of the following criteria, are not eligible for entry into the study:
- Patients requiring mechanical fixation other than Intramedullary nailing or plating (i.e. no external fixation)
- Patients with fractures that fall outside the diaphysis defined for the specific bone in question, i.e. no metaphyseal fractures.
- Patients with segmental circumferential bone loss >4cm.
- Patients whose fractures are the result of a tumour
- Infection per se, does not result in exclusion but it must be treated and the soft tissue envelope closed prior to randomization
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- Patients with known metabolic bone disease (other than osteoporosis) which would negatively impact on the bone healing process.
- Patients with known sensitivity to collagen.
- Patients who are pregnant or breastfeeding at the time of study enrolment.
- Patients currently being treated with radiation, chemotherapy, immunosuppression, or steroid therapy.
- Patients receiving any other investigational drug or treatment.
- Patients who have other injuries or conditions such as they are unable to communicate or consent
- m)Patients with known breast or prostate cancer
- Patients must be able and willing to provide informed consent, to complete study assessments, and to be followed for the period of the study.
Trial locations and contacts
1 site in 1 country.
About this study
We are inviting individuals such as yourself, who have diaphyseal fracture (broken bone) with a non union to participate in this research study. A non-union is a lack of bone healing (bone growth where the break in the bone occurred) after 3 months after the operation. The diaphyseal is an area of a specific bone (usually near the middle) where the fracture occurred. The bones we are interested in are the clavicle (collar bone), tibia (lower leg), femur (upper leg), humerus (upper arm) and forearm (lower arm). Treatment goals for these types of fractures are to minimize later surgeries, to assist the healing process, and to decrease the time to healing. The ability of a patient with non-union (lack of bone healing after 3 months post operation) to return to the work force and to normal activities more quickly not only has a good financial impact on society (community), but also improves over-all physical and mental well-being of the patients.
"Infuse" is a synthetic bone morphogenic protein which means it has the ability to help your bone to form and heal if inserted in the fracture site. "Infuse" may be the first commercially available product approved by Health Canada to accelerate the healing of long bone non-unions requiring surgical intervention.
Read more
Although the safety and efficacy of Infuse has been demonstrated through numerous pre-clinical studies, further human clinical trial is needed to evaluate the safety and the power to produce effects of this product particularly with respect to non unions of long bones. The purpose of this study is to evaluate the safety and the power to produce effects of Infuse implanted during treatment of long bone non unions to reduce later surgeries required to augment the healing process and to accelerate the time to healing.
Given this, the orthopaedic community has planned this study in order to scientifically establish the most effective treatment method to restore function after this type of injury.
Read the detailed description
We propose a multi-centre Canadian randomized Study wherein 80 patients are randomized (put in groups by no standard pattern ie. flipping a coin) to receive both autograft (sample of your own bone: iliac crest) and allograft (bone chips from bone bank) or "infuse" (synthetic bone morphogenic protein) and allograft using locked plates. Locked plates are surgical plates placed on the fracture in which the screws lock into the plate when they have been completely screwed into the bone through holes on the plate. Our objective is to assess the total cost of the patients treated in both study group and the benefits of the Infuse by comparing the new bone formation in the fracture site.
We will monitor critical aspects of operative care and rehabilitation at regular intervals, up to 2 year after surgery. We will independently monitor revision surgery (surgeries to repair a previous surgery) rates. We will also assess patients for functional health and quality of life outcomes.
- Conditions
- Non Union Diaphyseal Fractures
- Being tested
- Infuse Bone Morphogenic Protein (BMP) 2, iliac crest autograft
- Keywords
- Infuse, cost analysis, Non union diaphyseal fracture, The efficacy of Infuse BMP 2 in Non union diaphyseal fractures. Also the cost analysis with the amount of time spent in hospital post op.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infuse Bone Morphogenic Protein (BMP) 2Device
"Infuse" is a synthetic bone morphogenic protein which means it has the ability to help your bone to form and heal if inserted in the fracture site. "Infuse" may be the first commercially available product approved by Health Canada to accelerate the healing of long bone non-unions requiring surgical intervention.
iliac crest autograftProcedure or surgery
A piece of the patients iliac crest bone is take and mixed with bone from a bone bank to supplement the bone loss in the fracture
| Study group | Role | What they receive |
|---|---|---|
| 1 Infuse | Active comparator | The patient will receive BMP 2 with allograft Receives: Device: Infuse Bone Morphogenic Protein (BMP) 2 |
| 2 Iliac crest autograft | Active comparator | Autograft from Patients Iliac Crest and allograft Receives: Procedure: iliac crest autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost analysis based on length of hospital stay, allograft, blood products and costs associated with complications and/ or re-admission.
Measured: 2 years
Secondary outcomes (1)
Secondary efficacy end points will be the radiographic assessment of healing (RUST scale), the clinical assessment of weight-¬bearing status at 6 months post treatment, and the incidence of additional surgical/medical interventions to promote healing.
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 posted5 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2013
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Union Diaphyseal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ross Leighton
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Orthopaedic Trauma Society
- Responsible party
- Sponsor-investigator, Ross Leighton, Nova Scotia Health Authority
- Investigators
- Ross K Leighton, MD, Principal investigator, CDHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856479
- Sponsor's protocol ID
- Infuse Study
- Other IDs
- COTS Grant
- Acronym
- Infuse
- Status last verified
- Nov 2022
- First submitted
- 26 Feb 2009
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Cost Study of Infuse BMP 2 vs Iliac Crest Autograft for Non Union of Long Bone Fractures
- ClinicalTrials.gov ID
- NCT00856479
- Acronym / sponsor ID
- Infuse / Infuse Study
- Conditions
- Non Union Diaphyseal Fractures
- Keywords
- Infuse, cost analysis, Non union diaphyseal fracture, The efficacy of Infuse BMP 2 in Non union diaphyseal fractures. Also the cost analysis with the amount of time spent in hospital post op.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ross LeightonUniversity, hospital or other
- Collaborators
- Canadian Orthopaedic Trauma Society
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 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.
We are inviting individuals such as yourself, who have diaphyseal fracture (broken bone) with a non union to participate in this research study. A non-union is a lack of bone healing (bone growth where the break in the bone occurred) after 3 months after the operation. The diaphyseal is an area of a specific bone (usually near the middle) where the fracture occurred. The bones we are interested in are the clavicle (collar bone), tibia (lower leg), femur (upper leg), humerus (upper arm) and forearm (lower arm). Treatment goals for these types of fractures are to minimize later surgeries, to assist the healing process, and to decrease the time to healing. The ability of a patient with non-union (lack of bone healing after 3 months post operation) to return to the work force and to normal activities more quickly not only has a good financial impact on society (community), but also improves over-all physical and mental well-being of the patients.
"Infuse" is a synthetic bone morphogenic protein which means it has the ability to help your bone to form and heal if inserted in the fracture site. "Infuse" may be the first commercially available product approved by Health Canada to accelerate the healing of long bone non-unions requiring surgical intervention.
Although the safety and efficacy of Infuse has been demonstrated through numerous pre-clinical studies, further human clinical trial is needed to evaluate the safety and the power to produce effects of this product particularly with respect to non unions of long bones. The purpose of this study is to evaluate the safety and the power to produce effects of Infuse implanted during treatment of long bone non unions to reduce later surgeries required to augment the healing process and to accelerate the time to healing.
Given this, the orthopaedic community has planned this study in order to scientifically establish the most effective treatment method to restore function after this type of injury.
Detailed description
We propose a multi-centre Canadian randomized Study wherein 80 patients are randomized (put in groups by no standard pattern ie. flipping a coin) to receive both autograft (sample of your own bone: iliac crest) and allograft (bone chips from bone bank) or "infuse" (synthetic bone morphogenic protein) and allograft using locked plates. Locked plates are surgical plates placed on the fracture in which the screws lock into the plate when they have been completely screwed into the bone through holes on the plate. Our objective is to assess the total cost of the patients treated in both study group and the benefits of the Infuse by comparing the new bone formation in the fracture site.
We will monitor critical aspects of operative care and rehabilitation at regular intervals, up to 2 year after surgery. We will independently monitor revision surgery (surgeries to repair a previous surgery) rates. We will also assess patients for functional health and quality of life outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Infuse | Active comparator | Device: Infuse Bone Morphogenic Protein (BMP) 2The patient will receive BMP 2 with allograft |
| 2 Iliac crest autograft | Active comparator | Procedure: iliac crest autograftAutograft from Patients Iliac Crest and allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must require open surgical treatment of non-union of a diaphyseal fracture of the tibia, humerus, femur, radius or ulna sustained secondary to trauma.
- Patients must be candidates for surgical treatment with an intramedullary nail or locked or unlocked plate.
- Patients must have a fracture of the diaphysis as defined for that specific bone.
- Patients must show radiographic evidence of skeletal maturity (closed epiphyseal plates).
Key exclusion criteria (14 listed)
- Patients requiring mechanical fixation other than Intramedullary nailing or plating (i.e. no external fixation)
- Patients with fractures that fall outside the diaphysis defined for the specific bone in question, i.e. no metaphyseal fractures.
- Patients with segmental circumferential bone loss >4cm.
- Patients whose fractures are the result of a tumour
- Infection per se, does not result in exclusion but it must be treated and the soft tissue envelope closed prior to randomization
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 |
|---|---|---|
| Infuse Bone Morphogenic Protein (BMP) 2"Infuse" is a synthetic bone morphogenic protein which means it has the ability to help your bone to form and heal if inserted in the fracture site. "Infuse" may be the first commercially available product approved by Health Canada to accelerate the healing of long bone non-unions requiring surgical intervention. | Device | 1 Infuse |
| iliac crest autograftA piece of the patients iliac crest bone is take and mixed with bone from a bone bank to supplement the bone loss in the fracture | Procedure or surgery | 2 Iliac crest autograft |
Primary outcome
cost analysis based on length of hospital stay, allograft, blood products and costs associated with complications and/ or re-admission.
Time frame: 2 years
1 secondary outcome
Secondary efficacy end points will be the radiographic assessment of healing (RUST scale), the clinical assessment of weight-¬bearing status at 6 months post treatment, and the incidence of additional surgical/medical interventions to promote healing.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
Related trials for Non Union Diaphyseal Fractures
Not yet recruiting
Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails
Forearm Injuries, Radius Fractures
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.
Ross K Leighton, MD principal investigator
CDHA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infuse Bone Morphogenic Protein (BMP) 2 and iliac crest autograft in people with Non Union Diaphyseal Fractures, run by Ross Leighton at 1 site in Canada.
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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 14 Nov 2022. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
cost analysis based on length of hospital stay, allograft, blood products and costs associated with complications and/ or re-admission. (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 14 Nov 2022.