Non Union/Delayed Fractures
Conditions
Keywords
subjects sustaining Non union/delayed fractures and requiring surgical intervention for treatment
Brief summary
The study is a prospective, trial to test the safety and feasibility of injecting autologous, isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non union/delayed fractures. Another objective is to turn this procedure to a standard care protocol in our department .
Interventions
DEVICEthe Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.
Sponsors
Hadassah Medical Organization
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Ages: 18 to 65 2. Males- not involved in active military duty. 3. Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent. 4. Subjects must be available for follow-up for 1 year. 5Hard to heal fracture include the following: A. Fracture of the distal third of the tibial bone B. Segmental or open (II, IIIa an IIIB) fractures of the the tibia or femur diaphysis C.Articular fracture of the lower extremity (distal femur, tibial plateau and tibial pilon fractures) with significant metaphyseal comminution and/or bone loss.
Exclusion criteria
1. Active systemic or local infection. 2. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin) 3. Pathological Fractures. 4. Prior Fracture or Prior operation in the current fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical and radiological bony union at 3 months and 6 months. | — |
Countries
Israel
Contacts
Primary ContactHadas Lemberg, PhD
Outcome results
None listed