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

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ClinicalTrials.gov Identifier: NCT02491047
Recruitment Status : Active, not recruiting
First Posted : July 7, 2015
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
PolyPid Ltd.

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.

Condition or disease Intervention/treatment Phase
Tibial Fractures Open Fractures Device: BonyPid-1000 Other: Standard of Care (SOC) treatment Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Prevention
Official Title: Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
Actual Study Start Date : October 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BonyPid-1000
Implantation of BonyPid-1000 medical device, constructed of bone filler coated with controlled release antibiotic formulation, concomitantly with standard of care treatment (SOC)
Device: BonyPid-1000
BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment

Other: Standard of Care (SOC) treatment
Standard of Care (SOC) treatment only

Study control arm
Standard of care treatment (SOC) only
Other: Standard of Care (SOC) treatment
Standard of Care (SOC) treatment only




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Performance: Time to Radiographic-assessed bone healing [ Time Frame: During the 24-week follow-up period ]
    Time to radiographic-assessed bone healing, based on independent blinded central radio-graphic evaluations of the target fracture's X-rays.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491047


Locations
Israel
Rabin Medical Center
Petah Tiqva, Merkaz, Israel
Soroka Medical Center
Be'er Sheva`, Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Hadassah University Hospital
Jerusalem, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
The Chaim Sheba Medical Center
Tel Hashomer, Israel, 5262100
Philippines
De La Salle HSI
Cavite, Philippines
Philippines General Hospital
Manila City, Philippines
Philippine Orthopedic Center
Quezon City, Philippines
Sponsors and Collaborators
PolyPid Ltd.
Investigators
Study Director: Shany Blum, Dr. PolyPid Ltd.

Responsible Party: PolyPid Ltd.
ClinicalTrials.gov Identifier: NCT02491047     History of Changes
Other Study ID Numbers: BonyPid-1000TM-103
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Fractures, Open
Wounds and Injuries
Leg Injuries