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Core decompression with bone marrow injection : Preliminary results of a prospective randomized study assessing the effect of Rh-BMP7. 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.
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Core decompression with bone marrow injection : Preliminary results of a prospective randomized study assessing the effect of Rh-BMP7 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-BMP7 injection • Purpose • To asses this new method • To asses efficacy and tolerance of BMP7 injection with bone marrow
+/- BMP7 Patients and Methods (1) • Prospective randomized • Two arms 1) Decomp. + bone marrow 2) Decomp. + bone marrow + Rh-BMP7 • Randomization according to Rh-BMP7 (OP1) availability • Stages I to IIIA Ficat enrolled (Head deformity < 3mm) • Main criteria of results = rate of conversion to THR
Patients and Methods (2) • One surgeon • 24 hips included • Mean Follow-up = 12 months (6 to 30) • 12 hips in group BMP- and 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
3a -> 3b 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-BMP7 3b 3a 3b 3a
J0 J0 12 Months 30 Months Results (3) • Seven clinical failures • No significant difference according to : • AVN Ficat stages • Rh-BMP7 use • Etiology of AVN (steroids)
Conclusions (1) • Simple technique, allowing outpatient procedure and early recovery of full weight bearing • No adverse effect of using BMP7, but no advantage in terms of preventing THR conversion • But there was no assessment of bone marrow activity (confounding factor) • Incorrect randomization related to OP1 availability (cost)
J0 24 M 24 M 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
The future (3) • Starting a double blind randomized study comparing Core decompression versus Core decompression + bone marrow + BMP7 • Assessment of bone marrow activity (CFU-F, ….) • Results according to AVN volume on MRI • 80 hips followed 5 years (40 BMP+ / 40 BMP-)
Thank you for your Attention
J0 J0 12 Months 30 Months Results (3) • Seven clinical failures • No significant difference according to : • AVN Ficat stages • Rh-BMP7 use • Etiology of AVN (steroids)