CompletedPhase 3

A Comparative Study of 2 Doses of BM Autologous H-MSC+Biomaterial vs Iliac Crest AutoGraft for Bone Healing in Non-Union

France46 participantsStarted 2017-09-05

Plain-language summary

ORTHOUNION is a multi-centre, open, comparative, randomized, clinical trial with three parallel arms that aims to compare the efficacy of three treatments to enhance bone healing in patients with long bone non-union.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Age 18 years and older, both sexes
✓. Traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with a status of atrophic, oligotrophic or normotrophic non-union.
✓. Able to understand, accept and sign informed consent
✓. Medical health coverage
✓. Able to understand and accept the study constraints

Exclusion criteria

✕. Hypertrophic non-unions
✕. Segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc)
✕. Unrecovered vascular or neural injury
✕. Other fractures causing interference with weight bearing
✕. Visceral injuries or diseases interfering with callus formation (severe cranioencephalic trauma, etc.)
✕. Active infection of any location and aetiology
✕. Surgical contraindication of any cause
✕. Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.

What they're measuring

Bone consolidation

Timeframe: 12 months after treatment

Trial details

NCT IDNCT03325504

SponsorUniversidad Autonoma de Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-17

View on ClinicalTrials.gov More Non Union Fracture trials