Core decompression with bone marrow injection : Preliminary results of a prospective randomized study assessing the effect of Rh-BMP7 MIGAUD MIGAUD H,

Core decompression with bone Core decompression with bone marrow injection : marrow injection :

Preliminary results of a Preliminary results of a prospective randomized study prospective randomized study assessing the effect of Rh-assessing the effect of Rh-

BMP7BMP7MIGAUDMIGAUD H, BOCQUET D, PINOIT Y, MAY O, COTTEN

A, HERENT S, LAFFARGUE P

Services d’Orthopédie C et de Services d’Orthopédie C et de Radiologie Ostéo- Articulaire, CHRU Radiologie Ostéo- Articulaire, CHRU

de Lillede Lille

Introduction (1)Introduction (1)

•Disappointing results Disappointing results after core decompressionafter core decompression

•Frequent failures Frequent failures –Evolutive femoral head Evolutive femoral head deformitydeformity

–Sub-trochanteric fracturesSub-trochanteric fractures

•Long delay before weight Long delay before weight bearingbearing

•Unpredictable results Unpredictable results even at early stages of even at early stages of AVNAVN

Introduction (2)Introduction (2)•Core decompression Core decompression improvementimprovement–Percutaneous surgeryPercutaneous surgery–Autologus bone marrow injection Autologus bone marrow injection (but variable activity (but variable activity according to AVN etiology)according to AVN etiology)

–Rh-BMP7 injectionRh-BMP7 injection

•PurposePurpose–To asses this new method To asses this new method –To asses efficacy and tolerance To asses efficacy and tolerance of BMP7 injection with bone of BMP7 injection with bone marrowmarrow

Patients and Methods (1)Patients and Methods (1)

•Prospective randomizedProspective randomized•Two armsTwo arms

1)1) Decomp. + bone marrow Decomp. + bone marrow 2)2) Decomp. + bone marrow + Rh- Decomp. + bone marrow + Rh-BMP7BMP7

•Randomization according to Randomization according to Rh-BMP7 (OP1) availability Rh-BMP7 (OP1) availability

•Stages I to IIIA Ficat Stages I to IIIA Ficat enrolled (Head deformity < enrolled (Head deformity < 3mm)3mm)

•Main criteria of results = Main criteria of results = rate of conversion to THRrate of conversion to THR

+/- BMP7+/- BMP7

Patients and Methods (2)Patients and Methods (2)

•One surgeonOne surgeon•24 hips included24 hips included•Mean Follow-up = Mean Follow-up = 12 months (6 to 12 months (6 to 30)30)

•12 hips in group 12 hips in group BMP- and 12 in BMP- and 12 in group BMP+group BMP+

1 1

7

4 4

7

0

1

2

3

4

5

6

7

8

9

10

Stage 1 Stage 2 Stage 3

BMP- BMP+

13

8

12

-1

1

3

5

7

9

11

13

15

Alcoholic Steroids Metabolic Genetics

EtiologyEtiology of AVN of AVN

Results (1)Results (1)

• No infectionNo infection• All treated as All treated as outpatient except for 2 outpatient except for 2 patients who had patients who had controlateral THR at the controlateral THR at the same timesame time

• Immediate full weight Immediate full weight bearingbearing

• No sub-trochanteric No sub-trochanteric fracturefracture

• 4 heterotopic 4 heterotopic ossifications in vastus ossifications in vastus lateralis (all in BMP+ lateralis (all in BMP+ arm) arm) Spontaneous Spontaneous favorable healingfavorable healing

Results (2)Results (2)• Seven failures (THR Seven failures (THR conversion) conversion)

• 4 in BMP+ and 3 in BMP- arms4 in BMP+ and 3 in BMP- arms• 3 already converted 3 already converted

– All in BMP+ armAll in BMP+ arm– All were stages III before All were stages III before core decompression, one core decompression, one bilateral and one bilateral and one controlateral to THRcontrolateral to THR

• 4 were impending failures4 were impending failures– 1 Stage III (BMP+ arm)1 Stage III (BMP+ arm)– 2 Stages II (2 in BMP- arms)2 Stages II (2 in BMP- arms)– 1 Stage I (in BMP- arm) 1 Stage I (in BMP- arm) revised by a new core revised by a new core decompression + bone marrow + decompression + bone marrow + Rh-BMP7Rh-BMP7

3b3b 3a3a

3b3b 3a3a3a -> 3b3a -> 3b

Results (3)Results (3)•Seven clinical Seven clinical failuresfailures

•No significant No significant difference difference according to : according to : –AVN Ficat stagesAVN Ficat stages–Rh-BMP7 useRh-BMP7 use–Etiology of AVN Etiology of AVN (steroids)(steroids)

9

3

7

4

-1

1

3

5

7

9

11

13

15

Stages 1 + 2 Stage 3

Success Failure

9

3

8

4

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101214161820

BMP- BMP+

Success Failure

J0J0

30 Months30 Months

J0J0

12 Months12 Months

Conclusions (1)Conclusions (1)• Simple technique, allowing outpatient procedure Simple technique, allowing outpatient procedure and early recovery of full weight bearingand early recovery of full weight bearing

• No adverse effect of using BMP7, but no No adverse effect of using BMP7, but no advantage in terms of preventing THR conversionadvantage in terms of preventing THR conversion

• But there was no assessment of bone marrow But there was no assessment of bone marrow activity (confounding factor)activity (confounding factor)

• Incorrect randomization related to OP1 Incorrect randomization related to OP1 availabilityavailability (cost) (cost)

Conclusions (2)Conclusions (2)• BMP+ group had a higher BMP+ group had a higher rate of Stage III (but rate of Stage III (but NS). BMP prevented from NS). BMP prevented from a higher rate of a higher rate of failure ? failure ?

• MRI bone healing only MRI bone healing only in BMP+ armin BMP+ arm

• The procedure does not The procedure does not worsen a subsequent THR worsen a subsequent THR – no skin, muscular, bone no skin, muscular, bone scars scars

– no ossification after THR no ossification after THR conversion in BMP+ armconversion in BMP+ arm

1 1

7

4 4

7

0123456789

10

Stage 1 Stage 2 Stage 3

BMP- BMP+

24 M24 M

J0J0

24 M24 M

The future (3)The future (3)

•Starting a double blind randomized Starting a double blind randomized study comparing Core decompression study comparing Core decompression versus Core decompression + bone versus Core decompression + bone marrow + BMP7marrow + BMP7

•Assessment of bone marrow activity Assessment of bone marrow activity (CFU-F, ….)(CFU-F, ….)

•Results according to AVN volume on MRIResults according to AVN volume on MRI•80 hips followed 5 years (40 BMP+ / 40 80 hips followed 5 years (40 BMP+ / 40 BMP-)BMP-)

Thank you for yourThank you for your AttentionAttention

5

3

5

0

3

1

4

3

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10

Std 1/2 BMP- Std 1/2BMP+

Std 3 BMP- Std 3 BMP+

Succès Echec

40

13

7

-3

2

7

12

17

22

Ossifications Non

Succès Echec

NS

12

0

8

4

-113

579

1113

15

BMP- BMP+

Non Ossifications

P = 0,02

Results (3)Results (3)•Seven clinical Seven clinical failuresfailures

•No significant No significant difference difference according to : according to : –AVN Ficat stagesAVN Ficat stages–Rh-BMP7 useRh-BMP7 use–Etiology of AVN Etiology of AVN (steroids)(steroids)

9

3

7

4

-1

1

3

5

7

9

11

13

15

Stages 1 + 2 Stage 3

Success Failure

9

3

8

4

02468

101214161820

BMP- BMP+

Success Failure

J0J0

30 Months30 Months

J0J0

12 Months12 Months