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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02491047
Recruitment Status : Recruiting
First Posted : July 7, 2015
Last Update Posted : December 7, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Tibial Fractures Open Fractures Device: BonyPid-1000TM Procedure: Standard of Care (SOC) treatment

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo IIIA and IIIB Tibial Open Fractures
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BonyPid-1000TM
BonyPid-1000™ implantation concomitantly with standard of care treatment (SOC)
Device: BonyPid-1000TM
BonyPid-1000TM implantation concomitantly to standard of care (SOC) treatment
Active Comparator: Study control arm
Standard of care treatment (SOC) only
Procedure: Standard of Care (SOC) treatment
Standard of Care (SOC) treatment only

Outcome Measures

Primary Outcome Measures :
  1. Safety: Deep Infection in the target fracture site [ Time Frame: During the 4 weeks post index procedure ]
  2. Performance: Radiographic-assessed bone healing [ Time Frame: During the 24-week follow-up period ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Male or non-pregnant female with age ≥ 18 years and ≤70 years.
  2. Subjects with tibia open fractures of Gustilo grade, IIIA or IIIB
  3. Multi-injured subjects who are hemodynamically and physiologically stable
  4. 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.

Exclusion Criteria:

  1. Female who is pregnant or breastfeeding.
  2. Subjects with known current disseminated malignancies, active cancer or autoimmune diseases.
  3. Subjects with fractures due to known medical history of Osteoporosis.
  4. Diabetic subjects who are drug or insulin dependent.
  5. Heavy smokers in the last 6 months.
  6. Non-ambulating subjects prior to the trauma.
  7. Subjects admitted to Emergency Room (ER) more than 24 hours (> 24h) post injury.
  8. Subjects with bone fracture due to known medical history of metabolic bone diseases.
  9. Subjects with hypersensitivity to doxycycline and or tetracycline family of drugs.
  10. Subjects treated with systemic doxycycline during the last 4 weeks prior to screening.
  11. Previous surgical intervention in the target fracture site.
  12. Subjects currently receiving or have received an investigational product in the last 30 days and/or participate in another clinical trial.
Contacts and Locations

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

Contact: Rafael Weisz +972-74-719-5700 ext 193 rafael.s@polypid.com
Contact: Olga Belotserkovsky +972-74-719-5700 ext 138 olga.b@polypid.com

Rabin Medical Center Recruiting
Petah Tiqva, Merkaz, Israel
Contact: Eliezer Sidon, Dr    +972-50-8464317    eli.sidon@gmail.com   
Soroka Medical Center Recruiting
Be'er Sheva`, Israel
Contact: Asaf Aker, Dr.       aker@bgu.ac.il   
Contact: Layalee Abu Naser, Dr.    +972-50-7314964    LayaleeAb@clalit.org.il   
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Alina Rubinshtein    972-47772932    alina.rubinshtein@gmail.com   
Hadassah University Hospital Recruiting
Jerusalem, Israel
Contact: Meir Liebergall, Prof.    +972-2-6776342    liebergall@hadassah.org.il   
The Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Oleg Dolkart, PhD    :+972-524-262544    olegd@tlvmc.gov.il   
The Chaim Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel, 5262100
Contact: Orit Yoker    +972-3-5302417    sheba.ortho@gmail.com   
De La Salle HSI Recruiting
Cavite, Philippines
Contact: Jonathan Ronquillo, Dr.         
Philippines General Hospital Recruiting
Manila City, Philippines
Contact: Joseph Lai, Dr.         
Philippine Orthopedic Center Active, not recruiting
Quezon City, Philippines
Sponsors and Collaborators
PolyPid Ltd.
More Information

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: December 7, 2016
Last Verified: November 2016

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