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Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures

Primary Purpose

Tibial Fractures, Open Fractures

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BonyPid-1000
Standard of Care (SOC) treatment
Sponsored by
PolyPid Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tibial Fractures

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or non-pregnant female aged between 18 to 70 years of age.
  2. 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.
  3. 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.

  4. 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.

  5. 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.

Exclusion Criteria:

  1. Female who is pregnant or breastfeeding.
  2. 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.
  3. Subjects with fractures due to known medical history of Osteoporosis.
  4. Subject with known medical history of Diabetes.
  5. Heavy smokers (a smoker with a daily cigarettes consumption of more than 20 pieces) in the last 6 months.
  6. Drug/alcohol abusers
  7. Acute infection in another sites/organs.
  8. Non-ambulating subjects prior to the trauma.
  9. More than 24 hours between injury and systemic antibiotic treatment initiation
  10. Subjects with bone fracture due to known medical history of metabolic bone diseases.
  11. Subjects with high velocity gunshot bone fractures.
  12. Subjects with major intra-articular fractures
  13. Subjects with hypersensitivity to doxycycline and or tetracycline family of drugs.
  14. Subjects treated with systemic doxycycline during the last 4 weeks prior to screening.
  15. Previous surgical intervention in the target tibia
  16. Subject with previous open fractures within one year in the target tibia
  17. Subjects currently receiving or have received an investigational product in the last 30 days and/or participate in another clinical trial.

Sites / Locations

  • Rabin Medical Center
  • Soroka Medical Center
  • Rambam Health Care Campus
  • Hadassah University Hospital
  • The Tel Aviv Sourasky Medical Center
  • The Chaim Sheba Medical Center
  • De La Salle HSI
  • Philippines General Hospital
  • Philippine Orthopedic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

BonyPid-1000

Study control arm

Arm Description

Implantation of BonyPid-1000 medical device, constructed of bone filler coated with controlled release antibiotic formulation, concomitantly with standard of care treatment (SOC)

Standard of care treatment (SOC) only

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 2, 2015
Last Updated
May 17, 2020
Sponsor
PolyPid Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02491047
Brief Title
Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
Official Title
Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PolyPid Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures, Open Fractures

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BonyPid-1000
Arm Type
Experimental
Arm Description
Implantation of BonyPid-1000 medical device, constructed of bone filler coated with controlled release antibiotic formulation, concomitantly with standard of care treatment (SOC)
Arm Title
Study control arm
Arm Type
Other
Arm Description
Standard of care treatment (SOC) only
Intervention Type
Device
Intervention Name(s)
BonyPid-1000
Intervention Description
BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment
Intervention Type
Other
Intervention Name(s)
Standard of Care (SOC) treatment
Intervention Description
Standard of Care (SOC) treatment only
Primary Outcome Measure Information:
Title
Safety: Deep Infection in the target fracture site
Description
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.
Time Frame
During the 4 weeks post index procedure
Title
Performance: Radiographic-assessed bone healing
Description
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.
Time Frame
During the 24-week follow-up period
Secondary Outcome Measure Information:
Title
Performance: Time to Radiographic-assessed bone healing
Description
Time to radiographic-assessed bone healing, based on independent blinded central radio-graphic evaluations of the target fracture's X-rays.
Time Frame
During the 24-week follow-up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shany Blum, Dr.
Organizational Affiliation
PolyPid Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tiqva
State/Province
Merkaz
Country
Israel
Facility Name
Soroka Medical Center
City
Be'er Sheva'
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
Country
Israel
Facility Name
The Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
5262100
Country
Israel
Facility Name
De La Salle HSI
City
Cavite
Country
Philippines
Facility Name
Philippines General Hospital
City
Manila City
Country
Philippines
Facility Name
Philippine Orthopedic Center
City
Quezon City
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures

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