Core decompression with bone marrow injection Preliminary results

Core decompression with bone marrow injection : Preliminary results of a prospective randomized study assessing the effect of Rh-BMP 7 MIGAUD H, BOCQUET D, PINOIT Y, MAY O, COTTEN A, HERENT S, LAFFARGUE P Services d’Orthopédie C et de Radiologie Ostéo. Articulaire, CHRU de Lille

Introduction (1) • Disappointing results after core decompression • Frequent failures – Evolutive femoral head deformity – Sub-trochanteric fractures • Long delay before weight bearing • Unpredictable results even at early stages of AVN

Introduction (2) • Core decompression improvement – Percutaneous surgery – Autologus bone marrow injection (but variable activity according to AVN etiology) – Rh-BMP 7 injection • Purpose – To asses this new method – To asses efficacy and tolerance of BMP 7 injection with bone marrow

Patients and Methods (1) • Prospective randomized • Two arms 1) Decomp. + bone marrow 2) Decomp. + bone marrow + Rh-BMP 7 • Randomization according to Rh -BMP 7 (OP 1) availability • Stages I to IIIA Ficat enrolled (Head deformity < 3 mm) • Main criteria of results = rate of conversion to THR +/- BMP 7

Patients and Methods (2) • • • One surgeon 24 hips included Mean Follow-up = 12 months (6 to 30) • 12 hips in group BMPand 12 in group BMP+ Etiology of AVN

Results (1) • No infection • All treated as outpatient except for 2 patients who had controlateral THR at the same time • Immediate full weight bearing • No sub-trochanteric fracture • 4 heterotopic ossifications in vastus lateralis (all in BMP+ arm) Spontaneous favorable healing

Results (2) • • • Seven failures (THR conversion) 4 in BMP+ and 3 in BMP- arms 3 already converted – All in BMP+ arm – All were stages III before core decompression, one bilateral and one controlateral to THR • 4 were impending failures – 1 Stage III (BMP+ arm) – 2 Stages II (2 in BMP- arms) – 1 Stage I (in BMP- arm) revised by a new core decompression + bone marrow + Rh-BMP 7 3 b 3 b 3 a -> 3 b 3 a 3 a

Results (3) J 0 • Seven clinical failures • No significant difference according to : J 0 – AVN Ficat stages – Rh-BMP 7 use – Etiology of AVN (steroids) 12 Months 30 Months

Conclusions (1) • Simple technique, allowing outpatient procedure and early recovery of full weight bearing • No adverse effect of using BMP 7, but no advantage in terms of preventing THR conversion • But there was no assessment of bone marrow activity (confounding factor) • Incorrect randomization related to OP 1 availability (cost)

Conclusions (2) • BMP+ group had a higher rate of Stage III (but NS). BMP prevented from a higher rate of failure ? • MRI bone healing only in BMP+ arm • The procedure does not worsen a subsequent THR – no skin, muscular, bone scars – no ossification after THR conversion in BMP+ arm J 0 24 M

The future (3) • Starting a double blind randomized study comparing Core decompression versus Core decompression + bone marrow + BMP 7 • Assessment of bone marrow activity (CFU-F, …. ) • Results according to AVN volume on MRI • 80 hips followed 5 years (40 BMP+ / 40 BMP-)

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NS

P = 0, 02

Results (3) J 0 • Seven clinical failures • No significant difference according to : J 0 – AVN Ficat stages – Rh-BMP 7 use – Etiology of AVN (steroids) 12 Months 30 Months