Treatment of Osteonecrosis Head With Bone Marrow Aspirate

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COPYRIGHT © 2005 BY THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED

Treatment of Osteonecrosisof the Femoral Head withImplantation of AutologousBone-Marrow CellsSurgical TechniqueBy Valérie Gangji, MD, and Jean-Philippe Hauzeur, MD, PhD

Investigation performed at the Department of Rheumatology and Physical Medicine, Erasme University Hospital, Brussels, Belgium

The original scientific article in which the surgical technique was presented was published in JBJS Vol. 86-A, pp. 1153-1160, June 2004

INTRODUCTION

Core decompression of the hip with an 8-mm trephine is the mostcommon procedure used to treat the early stages of osteonecrosisof the femoral head1. Since the development of new data supportingthe potential of stem cells to induce tissue repair2, we began a two-

year prospective, controlled, double-blind study on the effect of implantation of bone-marrow cells into the zone of osteonecrosisof the femoral head through the trephine used for the coredecompression3.

SURGICAL TECHNIQUE

Bone-Marrow AspirationThe procedure is performed with the patient under general anes-thesia. The patient is placed on the operating table in a supine posi-tion with the arms stretched out to the sides. Under strictly sterile

conditions and following the intravenous administration of pro-phylactic antibiotics, a 3-mm incision is made at the level of the an-terior iliac crest on both sides. The needles for bone-marrowaspiration are introduced by hand deep into both iliac crests (Fig. 1),and the bone marrow is aspirated with 10-mL syringes rinsed witha buffer solution containing 400 mL of phosphate-buffered salinesolution, 25,000 U of heparin, and 100 mL of human albumin toavoid clotting. The contents of each syringe are then transferred intothe bag of the bone-marrow-collection kit (R4R 2107; Baxter, Deer-field, Illinois) to obtain a final volume of 400 mL of bone marrow

ABSTRACT

BACKGROUND:

Aseptic nontraumatic osteone-

crosis of the femoral head is adisorder that can lead to femoral

head collapse and the need for

total hip replacement. Since os-

teonecrosis may be a disease of

mesenchymal cells or bone

cells, the possibility has been

raised that bone marrow con-

taining osteogenic precursors

implanted into a necrotic lesion

of the femoral head may be of

benefit in the treatment of this

condition. For this reason, we

studied the implantation of au-

tologous bone-marrow mononu-

clear cells in a necrotic lesion of

the femoral head to determine

the effect on the clinical symp-

toms and the stage and volume

of osteonecrosis.

continued



TH E JO U R N A L OF BON E & JOINT SU R G E R Y · SURGICAL TECHNIQUES MARCH 2005 · VOLUME 87-A · SUPPLEMENT 1, PAR T 1 · JBJS.OR G

(Fig. 2). The rest of the bone-marrow preparation takes placein a sterile room in the cellularand molecular therapy unit, asdescribed below. In the mean-time, the second step of the pro-cedure, the core decompression,is accomplished.

Core DecompressionA c-arm fluoroscope is drapedwith a sterile sleeve and is posi-tioned over the hip region to al-

ABSTRACT | continued

METHODS:

We studied thirteen patients (eighteen hips) with stage-I or II osteonecrosisof the femoral head, according to the system of the Association Research

Circulation Osseous. The hips were allocated to a program of either core de-

compression (the control group) or core decompression and implantation of

autologous bone-marrow mononuclear cells (the bone-marrow-graft group).

Both patients and assessors were blind with respect to treatment-group

assignment. The primary outcomes studied were safety, clinical symptoms,

and disease progression.

continued

FIG. 1

The needles for the bone-marrow aspiration are introduced deep into both iliac crests, and the bone marrow is aspirated with 10-mL

syringes.




low an anteroposterior viewand, after flexion of the kneeand abduction of the hip, a frog-leg lateral view of the proximalpart of the femur (Fig. 3). Underfluoroscopic control, a 5-mmincision is made laterally

through the skin and the fasciaat the level of, or just distal to,the greater trochanter (Fig. 4). Adrill hole is made manually inthe lateral femoral cortex. A3-mm trephine (ChirurgicalMaintenance, Brussels, Bel-gium) is then inserted manually under fluoroscopic control

through the trochanter, the fem-oral neck, and the femoral headto the necrotic lesion (Fig. 5), asdescribed by one of us (J.-P.H.)and colleagues4,5. The directionof the trephine must be ad-

justed in both planes so that it ispointing toward the necroticzone (Fig. 6). The position of

FIG. 2

After the bone-marrow aspiration, the contents of each syringe are transferred into the

bone-marrow-collection kit.

ABSTRACT | continued

RESULTS:

After twenty-four months, there

was a significant reduction in

pain (p = 0.021) and in joint

symptoms measured with the

Lequesne index (p = 0.001) and

the WOMAC index (p = 0.013)

within the bone-marrow-graft

group. At twenty-four months,

five of the eight hips in the con-

trol group had deteriorated to

stage III, whereas only one of

the ten hips in the bone-marrow-

graft group had progressed to

this stage. Survival analysis

showed a significant difference

in the time to collapse between

the two groups (p = 0.016).

Implantation of bone-marrow

mononuclear cells was asso-

ciated with only minor side

effects.

CONCLUSIONS:

Implantation of autologous

bone-marrow mononuclear cells

appears to be a safe and effec-

tive treatment for early stages of

osteonecrosis of the femoral

head. Although the findings of

this study are promising, their

interpretation is limited because

of the small number of patients

and the short duration of follow-

up. Further study is needed to

confirm the results.




the trephine must be checked onboth the anteroposterior andthe lateral fluoroscopic view. Fi-

nally, the tip of the trephine isplaced at a distance of 2 to 3 mmfrom the articular cartilage(Fig. 7).

Bone-Marrow Grafting In the cellular and moleculartherapy unit, the bone marrow isfiltered to eliminate bone spi-cules, fat, and cellular debris.

FIG. 3

A c-arm fluoroscope is positioned over the hip region like an arch. This allows the surgeon to obtain anteroposterior and frog-leg views of

the hip.

CRITICAL CONCEPTS

INDICATIONS:

Stage-I or II osteonecrosis of the femoral head, according to the system of the Association Research Circulation Osseous6.

CONTRAINDICATIONS:

Skin lesions affecting the lower limb

• Active infection

• Coagulopathy

• Anemia (hemoglobin level of <100 g/L) and leukopenia (total leukocyte

count of <4000/mm³ [<4.0 × 109 /L])

continued




The bone-marrow cells are thengravity-filtered through a seriesof successively smaller-diametermesh filters and are collected in asterile plastic transfer pack.Mononuclear cells are sorted ona Spectra cell separator (777006-300; Cobe, Lakewood, Colo-rado) and are concentrated to afinal volume of 50 mL. Bacterialand fungal cultures are per-formed routinely.

The mean number of leu-kocytes (and standard error of the mean) injected in our study was 2.0 ± 0.3 × 109, including1.0% ± 0.2% of CD34+ cells,which are precursors of hemato-poietic cells. Fibroblast colony-forming units were used as anindicator of stromal cell activity.The mean number of fibroblast

FIG. 4

A 5-mm incision is made laterally through the skin and the fascia at the level of, or just

distal to, the greater trochanter.

FIG. 5

The trephine (with an outer diameter of 5 mm and an inner diameter of 3 mm) used for the core decompression.




colony-forming units was 92 ±9/107 cells. The sorted bonemarrow-mononuclear cellscontained lymphocytoid cells(mean, 29% ± 2.2%), mono-cytoid cells (4% ± 1%), andmyeloid cells (6% ± 1.3%)3.

Injection of the Bone Marrow The 50 mL of mononuclear cellsis then injected through the tre-phine that was placed into thenecrotic lesion. It is possible toinject 50 mL since the necroticzone contains intertrabecularspaces that can be filled with

FIG. 7

Fig. 6 The direction of the trephine must be ad-

justed in both the anteroposterior and the lateral

plane so that it is pointing toward the osteone-

crotic zone.Fig. 7 The tip of the trephine is placed at a dis-

tance of 2 to 3 mm from the articular cartilage.

FIG. 6

CRITICAL CONCEPTS | continued

PITFALLS:

• Pain at the site of the bone-

marrow aspiration

• Hematoma at the site of the

core decompression

• The trephine can be inserted

too close to the articular carti-

lage. Therefore, the position

of the trephine must be

checked carefully on both the

anteroposterior and the frog-leg lateral fluoroscopic view.

• Because of the small diame-

ter of the trephine, it is possi-

ble to bend it, especially in

the region of the femoral

neck. Therefore, the trephine

should be introduced very

carefully by hand.

continued




bone marrow. The injection isperformed slowly over a few

minutes (Fig. 8). In some but notall cases, the pressure required toinject the marrow is quite highand leakage of marrow may oc-cur through the trephine site.However, this has not been aproblem.

Postoperative CarePostoperatively, all patients are

treated prophylactically fortwenty-four hours with an intra-venous infusion of cefazolin. Theaverage hospital stay is three days.Patients remain non-weight-bearing on the operatively treatedside for three weeks, after whichtotal weight-bearing is permitted.Sutures are removed seven daysafter the surgery.

NOTE: The authors thank Dr. M. Toungouz and Ms. M. Lam-bermont for their help in the bone-marrow preparation.

Valérie Gangji, MD

Jean-Philippe Hauzeur, MD, PhD

Department of Rheumatology and Physical Medi-

cine, Erasme University Hospital, 808 Route de

Lennik, 1070 Brussels, Belgium. E-mail address

for V. Gangji: [email protected]

The authors did not receive grants or outside fund-ing in support of their research or preparation of

this manuscript. They did not receive payments or

other benefits or a commitment or agreement to

provide such benefits from a commercial entity.

No commercial entity paid or directed, or agreed

to pay or direct, any benefits to any research fund,

foundation, educational institution, or other chari-

table or nonprofit organization with which the

authors are affiliated or associated.

doi:10.2106/JBJS.D.02662

REFERENCES1. Steinberg ME, Larcom PG, Stafford BB,

Hosick WB, Corces A, Bands RE, HartmannKM. Treatment of osteonecrosis of the

femoral head by core decompression, bone

grafting, and electrical stimulation. In: Urban-

iak JR, Jones JP Jr, editors. Osteonecrosis:

etiology, diagnosis, and treatment. Rose-

mont, IL: American Academy of Orthopaedic

Surgeons; 1997. p 293-9.

2. Korbling M, Estrov Z. Adult stem cells for

tissue repair—a new therapeutic concept? N

Engl J Med. 2003;349:570-82.

3. Gangji V, Hauzeur JP, Matos C, De Maerte-

laer V, Toungouz M, Lambermont M. Treat-

ment of osteonecrosis of the femoral head

with implantation of autologous bone-marrow

cells. A pilot study. J Bone Joint Surg Am.

2004;86:1153-60.

4. Hauzeur JP, Orloff S, Taverne-Verbanck J,

Pasteels JL. Diagnosis of aseptic osteonecro-

sis of the femoral head by percutaneous tran-

strochanterian needle biopsy. Clin

Rheumatol. 1986;5:346-58.

5. Hauzeur JP, Sintzoff S Jr, Appelboom T, De

Maertelaer V, Bentin J, Pasteels JL. Relation-

ship between magnetic resonance imaging

and histologic findings by bone biopsy in non-

traumatic osteonecrosis of the femoral head.

J Rheumatol. 1992;19:385-92.

6. ARCO (Association Research CirculationOsseous). Committee on Terminology

and Classification. ARCO News. 1992;

4:41-6.

FIG. 8

The 50 mL of mononuclear cells is injected through the trephine that was placed into the

necrotic lesion. The injection is performed slowly over a few minutes.

CRITICAL CONCEPTS | continued

AUTHOR UPDATE:

There have been no changes in the

surgical technique since the time

of publication of the original paper.

Treatment of Osteonecrosis Head With Bone Marrow Aspirate

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