Tibial FracturesNCT02491047
Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
A study testing BonyPid-1000 in people with Tibial Fractures and Open Fractures, run by PolyPid Ltd. at 9 sites in 2 countries.
Trial summary
This is a prospective, multi-national, multicenter, randomized, two arms, single blind, Standard of Care (SOC) controlled, with blinded central reading center study. This study will assess the safety and performance of BonyPid-1000™ in severe open tibial fractures (Gustilo IIIA and IIIB) when implanted as adjunct to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tibial Fractures, Open Fractures
- What is being tested?
- BonyPid-1000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Oct 2015to Sep 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female aged between 18 to 70 years of age.
- Female of childbearing potential should have a negative urine pregnancy test prior to index procedure Note: All female of childbearing potential must agree to use a highly effective method of contraception consistently and correctly for the duration of the study.
- Subjects with tibia open fractures of Gustilo grade I, II, IIIA or IIIB, who are assigned for surgery and are suitable for bone filler implantation, are eligible to participate in the study.
- Single or multi-injured subjects who are hemodynamically and physiologically stable.
- Note: A multi-injured subject is defined as one who sustains ≥2 injuries, each injury requiring hospitalization, independently of the presence of other injuries.
- Subjects who are able and willing to sign an informed consent form, prior to any protocol-specific procedures being performed and accept to comply with protocol requirements for the duration of the study. In specific cases, due to medical condition (e.g. a medical condition which necessitate an immediate medical treatment), a shortened consenting process may take place in accordance with local regulations.
Who cannot join
- Female who is pregnant or breastfeeding.
- Subjects with known current disseminated malignancies, active cancer or autoimmune diseases. Note: active cancer defined as - cancer for which therapeutic or palliative treatment is either ongoing at the time of enrolment or has stopped less than six (6) months before enrolment.
- Subjects with fractures due to known medical history of Osteoporosis.
- Subject with known medical history of Diabetes.
- Heavy smokers (a smoker with a daily cigarettes consumption of more than 20 pieces) in the last 6 months.
- Drug/alcohol abusers
Show all 17Show fewer
- Acute infection in another sites/organs.
- Non-ambulating subjects prior to the trauma.
- More than 24 hours between injury and systemic antibiotic treatment initiation
- Subjects with bone fracture due to known medical history of metabolic bone diseases.
- Subjects with high velocity gunshot bone fractures.
- Subjects with major intra-articular fractures
- Subjects with hypersensitivity to doxycycline and or tetracycline family of drugs.
- Subjects treated with systemic doxycycline during the last 4 weeks prior to screening.
- Previous surgical intervention in the target tibia
- Subject with previous open fractures within one year in the target tibia
- Subjects currently receiving or have received an investigational product in the last 30 days and/or participate in another clinical trial.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Israel6 sites
Soroka Medical Center
Beersheba
Rambam Health Care Campus
Haifa, 31096
Hadassah University Hospital
Jerusalem
Rabin Medical Center
Petah Tikva, Central District
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
The Chaim Sheba Medical Center
Tel HaShomer, 5262100
Philippines3 sites
De La Salle HSI
Cavite
Philippines General Hospital
Manila
Philippine Orthopedic Center
Quezon City
About this study
This is a prospective, multi-national, multicenter, randomized, two arms, single blind, Standard of Care (SOC) controlled, with blinded central reading center study. This study will assess the safety and performance of BonyPid-1000™ in severe open tibial fractures (Gustilo IIIA and IIIB) when implanted as adjunct to SOC and compared to SOC alone.
Read the detailed description
The study population include subjects with a classification of Gustilo I, II, IIIA or IIIB of tibial open fractures, assigned for surgical procedure, who meet eligibility criteria and provide signed informed consent.
Subjects will be randomized into either Study investigational arm or Study control arm, using a 1:1 ratio. Randomization will be stratified by Gustilo classification (I and II; IIIA ; IIIB).
Total duration of the study is expected to be approximately 32 months from first subject enrolled until last subject completed.
It is expected that each subject will be in the study for approximately 52 weeks
Subjects will be followed at the following time points:
- Immediately post index procedure
- During hospitalization
- Discharge visit
- 4 weeks and then monthly up to 24 weeks, 36 and at 52 weeks.
This is a single blind clinical trial. Subjects and their family members will be blinded to the treatment arms assignment. The study site personnel present at the baseline procedure as well as the physician performing the procedure will be trained not to disclose the treatment arm to the subject, his/her family, and to health care providers outside of the Orthopedic department.
An independent X-ray reading center assessing all subjects' images will be blinded to the treatment arms assignments, for the entire trial period. However, due to the radiographic appearance of the BonyPid-1000 as compared to SOC may differ, it is not entirely possible to blind the evaluating radiologists.
- Conditions
- Tibial Fractures, Open Fractures
- Being tested
- BonyPid-1000, Standard of Care (SOC) treatment
- Medical subject headings
- Tibial Fractures, Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BonyPid-1000Device
BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment
Standard of Care (SOC) treatmentOther
Standard of Care (SOC) treatment only
| Study group | Role | What they receive |
|---|---|---|
| BonyPid-1000 | Experimental | Implantation of BonyPid-1000 medical device, constructed of bone filler coated with controlled release antibiotic formulation, concomitantly with standard of care treatment (SOC) Receives: Device: BonyPid-1000; Other: Standard of Care (SOC) treatment |
| Study control arm | Other | Standard of care treatment (SOC) only Receives: Other: Standard of Care (SOC) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Deep Infection in the target fracture site
Deep Infection in the target fracture site during the 4 weeks post index procedure. The endpoint will be assessed by calculating the rate /percent per group.
Measured: During the 4 weeks post index procedure
Performance: Radiographic-assessed bone healing
Radiographic-assessed bone healing during the 24-week follow-up period, based on independent blinded central radio-graphic evaluations of the target fracture's X-rays.
Measured: During the 24-week follow-up period
Secondary outcomes (1)
Performance: Time to Radiographic-assessed bone healing
Time to radiographic-assessed bone healing, based on independent blinded central radio-graphic evaluations of the target fracture's X-rays.
Measured: During the 24-week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized into either Study investigational arm or Study control arm, using a 1:1 ratio. Randomization will be stratified by Gustilo classification (I and II; IIIA ; IIIB). In the study treatment arm patients will receive BonyPid-1000 in addition to the standard of care treatment. in the control arm patients will receive the standard of care treatment alone.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- PolyPid Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shany Blum, Dr., Study director, PolyPid Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491047
- Sponsor's protocol ID
- BonyPid-1000TM-103
- Status last verified
- May 2020
- First submitted
- 2 Jul 2015
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
- ClinicalTrials.gov ID
- NCT02491047
- Acronym / sponsor ID
- BonyPid-1000TM-103
- Conditions
- Tibial Fractures, Open Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- PolyPid Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 7 Jul 2015 (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 is a prospective, multi-national, multicenter, randomized, two arms, single blind, Standard of Care (SOC) controlled, with blinded central reading center study. This study will assess the safety and performance of BonyPid-1000™ in severe open tibial fractures (Gustilo IIIA and IIIB) when implanted as adjunct to SOC and compared to SOC alone.
Detailed description
The study population include subjects with a classification of Gustilo I, II, IIIA or IIIB of tibial open fractures, assigned for surgical procedure, who meet eligibility criteria and provide signed informed consent.
Subjects will be randomized into either Study investigational arm or Study control arm, using a 1:1 ratio. Randomization will be stratified by Gustilo classification (I and II; IIIA ; IIIB).
Total duration of the study is expected to be approximately 32 months from first subject enrolled until last subject completed.
It is expected that each subject will be in the study for approximately 52 weeks
Subjects will be followed at the following time points:
- Immediately post index procedure
- During hospitalization
- Discharge visit
- 4 weeks and then monthly up to 24 weeks, 36 and at 52 weeks.
This is a single blind clinical trial. Subjects and their family members will be blinded to the treatment arms assignment. The study site personnel present at the baseline procedure as well as the physician performing the procedure will be trained not to disclose the treatment arm to the subject, his/her family, and to health care providers outside of the Orthopedic department.
An independent X-ray reading center assessing all subjects' images will be blinded to the treatment arms assignments, for the entire trial period. However, due to the radiographic appearance of the BonyPid-1000 as compared to SOC may differ, it is not entirely possible to blind the evaluating radiologists.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will be randomized into either Study investigational arm or Study control arm, using a 1:1 ratio. Randomization will be stratified by Gustilo classification (I and II; IIIA ; IIIB). In the study treatment arm patients will receive BonyPid-1000 in addition to the standard of care treatment. in the control arm patients will receive the standard of care treatment alone.
| Arm | Type | Receives |
|---|---|---|
| BonyPid-1000 | Experimental | Device: BonyPid-1000, Other: Standard of Care (SOC) treatmentImplantation of BonyPid-1000 medical device, constructed of bone filler coated with controlled release antibiotic formulation, concomitantly with standard of care treatment (SOC) |
| Study control arm | Other | Other: Standard of Care (SOC) treatmentStandard of care treatment (SOC) only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-pregnant female aged between 18 to 70 years of age.
- Female of childbearing potential should have a negative urine pregnancy test prior to index procedure Note: All female of childbearing potential must agree to use a highly effective method of contraception consistently and correctly for the duration of the study.
- Subjects with tibia open fractures of Gustilo grade I, II, IIIA or IIIB, who are assigned for surgery and are suitable for bone filler implantation, are eligible to participate in the study.
- Single or multi-injured subjects who are hemodynamically and physiologically stable.
- Note: A multi-injured subject is defined as one who sustains ≥2 injuries, each injury requiring hospitalization, independently of the presence of other injuries.
Key exclusion criteria (17 listed)
- Female who is pregnant or breastfeeding.
- Subjects with known current disseminated malignancies, active cancer or autoimmune diseases. Note: active cancer defined as - cancer for which therapeutic or palliative treatment is either ongoing at the time of enrolment or has stopped less than six (6) months before enrolment.
- Subjects with fractures due to known medical history of Osteoporosis.
- Subject with known medical history of Diabetes.
- Heavy smokers (a smoker with a daily cigarettes consumption of more than 20 pieces) in the last 6 months.
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 |
|---|---|---|
| BonyPid-1000BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment | Device | BonyPid-1000 |
| Standard of Care (SOC) treatmentStandard of Care (SOC) treatment only | Other | BonyPid-1000, Study control arm |
Primary outcome
Safety: Deep Infection in the target fracture site
Time frame: During the 4 weeks post index procedure
Deep Infection in the target fracture site during the 4 weeks post index procedure. The endpoint will be assessed by calculating the rate /percent per group.
Performance: Radiographic-assessed bone healing
Time frame: During the 24-week follow-up period
Radiographic-assessed bone healing during the 24-week follow-up period, based on independent blinded central radio-graphic evaluations of the target fracture's X-rays.
1 secondary outcome
Performance: Time to Radiographic-assessed bone healing
Time frame: During the 24-week follow-up period
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 19 May 2020.
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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.
Shany Blum, Dr. study director
PolyPid Ltd.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BonyPid-1000 in people with Tibial Fractures and Open Fractures, run by PolyPid Ltd. at 9 sites in 2 countries.
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 17 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Israel, Philippines. 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?
Safety: Deep Infection in the target fracture site (time frame: During the 4 weeks post index procedure). The study lists 2 primary outcomes in all. 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 19 May 2020.