- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02491047
Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Cavite, Filippinerna
- De La Salle HSI
-
Manila City, Filippinerna
- Philippines General Hospital
-
Quezon City, Filippinerna
- Philippine Orthopedic Center
-
-
-
-
-
Be'er Sheva', Israel
- Soroka Medical Center
-
Haifa, Israel, 31096
- Rambam Health Care Campus
-
Jerusalem, Israel
- Hadassah University Hospital
-
Tel Aviv, Israel, 64239
- The Tel Aviv Sourasky Medical Center
-
Tel Hashomer, Israel, 5262100
- The Chaim Sheba Medical Center
-
-
Merkaz
-
Petah Tiqva, Merkaz, Israel
- Rabin Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Subject with previous open fractures within one year in the target tibia
- Subjects currently receiving or have received an investigational product in the last 30 days and/or participate in another clinical trial.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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)
|
BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment
Standard of Care (SOC) treatment only
|
Övrig: Study control arm
Standard of care treatment (SOC) only
|
Standard of Care (SOC) treatment only
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Safety: Deep Infection in the target fracture site
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Performance: Time to Radiographic-assessed bone healing
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Shany Blum, Dr., PolyPid Ltd.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BonyPid-1000TM-103
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Tibiafrakturer
-
Austin V StoneAvslutadFrämre korsbandsrivning | Tibial menisk skador | Tibial menisk tårar | Tibial menisk, rivenFörenta staterna
-
Spaulding Rehabilitation HospitalAvslutad
-
University of WinchesterHampshire Hospitals NHS Foundation TrustUpphängdHög tibial osteotomi med allograftkil | Hög tibial osteotomi utan allograftkil | Före och postoperativa fysiska aktivitetsnivåerStorbritannien
-
Health Centre Nørrebro, City of CopenhagenHvidovre University HospitalAvslutadTibial menisk skador | Brosk, ledDanmark
-
CHU de ReimsAvslutadSeptisk Tibial Icke-unionFrankrike
-
Fowler Kennedy Sport Medicine ClinicAvslutadÖppningskil hög tibial osteotomiKanada
-
Loma Linda UniversityAvslutadKnäoperation | Distal femoral | Proximal tibialFörenta staterna
-
Kessler FoundationWalter Reed National Military Medical Center; Uniformed Services University...RekryteringKnäskador | Knäskador och störningar | Tibial menisk skadorFörenta staterna
-
Tampere University HospitalPihlajalinna Hospital, TampereHar inte rekryterat ännuRehabilitering | Patella Alta | Tibial Tubercle Distalisation Osteotomi
-
New Jersey Regenerative Institute, LLCAvslutadArtros, knä | Tibial menisk skador
Kliniska prövningar på BonyPid-1000
-
PolyPid Ltd.MIS Implant Technologies, LtdAvslutad
-
Vyaire MedicalHar inte rekryterat ännuVentilationsterapi; Komplikationer
-
University of California, IrvineAvslutadCerebral ischemiFörenta staterna
-
NeuroEM Therapeutics, Inc.University of South Florida Health / Byrd Alzheimer's InstituteOkändAlzheimers sjukdom | Alzheimers sjukdom, sent inträdandeFörenta staterna
-
HeadSense MedicalRigshospitalet, DenmarkOkändIntrakraniell hypertoniDanmark, Tyskland, Nederländerna
-
HeadSense MedicalState Medical Center, Republic of ArmeniaAvslutad
-
TaiGen Biotechnology Co., Ltd.R&G Pharma Studies Co.,Ltd.Avslutad
-
HeadSense MedicalUniversity of Maryland, College ParkOkändSubaraknoidal blödning | Vasospasm, intrakraniellFörenta staterna
-
HeadSense MedicalUpphängdStroke | Hjärnskador | Neoplasmer i hjärnan | Intrakraniell hypertoni | HydrocephalusJapan
-
HeadSense MedicalElisabeth-TweeSteden ZiekenhuisAvslutadHjärnskador | Intrakraniell hypertoniNederländerna