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

17 maggio 2020 aggiornato da: PolyPid Ltd.
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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

51

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Filippine
      • Cavite, Filippine
        • De La Salle HSI
      • Manila City, Filippine
        • Philippines General Hospital
      • Quezon City, Filippine
        • Philippine Orthopedic Center
  • Israele
      • Be'er Sheva', Israele
        • Soroka Medical Center
      • Haifa, Israele, 31096
        • Rambam Health Care Campus
      • Jerusalem, Israele
        • Hadassah University Hospital
      • Tel Aviv, Israele, 64239
        • The Tel Aviv Sourasky Medical Center
      • Tel Hashomer, Israele, 5262100
        • The Chaim Sheba Medical Center
    • Merkaz
      • Petah Tiqva, Merkaz, Israele
        • Rabin Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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)
Dispositivo: BonyPid-1000
BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment
Altro: Standard of Care (SOC) treatment
Standard of Care (SOC) treatment only
Altro: Study control arm
Standard of care treatment (SOC) only
Altro: Standard of Care (SOC) treatment
Standard of Care (SOC) treatment only

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety: Deep Infection in the target fracture site
Lasso di tempo: 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.
During the 4 weeks post index procedure
Performance: Radiographic-assessed bone healing
Lasso di tempo: 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.
During the 24-week follow-up period

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Performance: Time to Radiographic-assessed bone healing
Lasso di tempo: 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.
During the 24-week follow-up period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

PolyPid Ltd.

Investigatori

  • Direttore dello studio: Shany Blum, Dr., PolyPid Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 ottobre 2015

Completamento primario (Effettivo)

1 settembre 2018

Completamento dello studio (Effettivo)

1 settembre 2018

Date di iscrizione allo studio

Primo inviato

2 luglio 2015

Primo inviato che soddisfa i criteri di controllo qualità

6 luglio 2015

Primo Inserito (Stima)

7 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 maggio 2020

Ultimo verificato

1 maggio 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BonyPid-1000TM-103

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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