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

NCT02491047 | Completed

• 1 other identifier: BonyPid-1000TM-103
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 9

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.

Conditions

Tibial Fractures; Open Fractures

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  During the 24-week follow-up period

Secondary Outcomes (1)

• Performance: Time to Radiographic-assessed bone healing

  During the 24-week follow-up period

Study Arms (2)

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)

Device: BonyPid-1000; Other: Standard of Care (SOC) treatment

Study control arm

OTHER

Standard of care treatment (SOC) only

Other: Standard of Care (SOC) treatment

Interventions

BonyPid-1000 DEVICE

BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment

BonyPid-1000

Standard of Care (SOC) treatment OTHER

Standard of Care (SOC) treatment only

BonyPid-1000; Study control arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PolyPid Ltd.: lead

Study Sites (9)

Rabin Medical Center

Petah Tikva, Central District, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Hadassah University Hospital

Jerusalem, Israel

Location

The Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 5262100, Israel

Location

De La Salle HSI

Cavite, Philippines

Location

Philippines General Hospital

Manila, Philippines

Location

Philippine Orthopedic Center

Quezon City, Philippines

Location

MeSH Terms

Conditions

Tibial Fractures; Fractures, Open

Interventions

Standard of Care; Therapeutics

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shany Blum, Dr.

  PolyPid Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 7, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

IL (6); PH (3)