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

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by PolyPid Ltd.
Sponsor:
Information provided by (Responsible Party):
PolyPid Ltd.
ClinicalTrials.gov Identifier:
NCT02491047
First received: July 2, 2015
Last updated: December 6, 2016
Last verified: November 2016
  Purpose
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 Intervention
Tibial Fractures Open Fractures Device: BonyPid-1000TM Procedure: Standard of Care (SOC) treatment

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by PolyPid Ltd.:

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

Estimated Enrollment: 64
Study Start Date: October 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02491047

Contacts
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

Locations
Israel
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   
Philippines
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
Study First Received: July 2, 2015
Last Updated: December 6, 2016

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

ClinicalTrials.gov processed this record on September 21, 2017