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Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures

Israel

Plain-language 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 .

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Ages: 18 to 65
✓. Males- not involved in active military duty.
✓. 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.
✓. Subjects must be available for follow-up for 1 year. 5"Hard 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

✕. Active systemic or local infection.
✕. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
✕. Pathological Fractures.
✕. Prior Fracture or Prior operation in the current fracture

What they're measuring

clinical and radiological bony union at 3 months and 6 months.

Trial details

NCT IDNCT01435434

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

Contact for this trial

Hadas Lemberg, PhD

00 972 2 6777572 lhadas@hadassah.org.il

View on ClinicalTrials.gov More Non Union/Delayed Fractures trials