The Journal of Bone and Joint Surgery (American). 2007;89:2485-2497.
doi:10.2106/JBJS.C.01627
© 2007 The Journal of Bone and Joint Surgery, Inc.
Biologic Augmentation of Rotator Cuff Tendon-Healing with Use of a Mixture of Osteoinductive Growth Factors*
Scott A. Rodeo, MD1,
Hollis G. Potter, MD1,
Sumito Kawamura, MD1,
A. Simon Turner, BVSc, MS, Dipl ACVS1,
Hyon Jeong Kim, MD, PhD1 and
Brent L. Atkinson, PhD1
1 The Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021.
E-mail address for S.A. Rodeo:
rodeos{at}hss.edu
Investigation performed at The Laboratory for Soft Tissue Research and
the Sports Medicine and Shoulder Service, The Hospital for Special Surgery,
New York, NY
Disclosure: In support of their research for or preparation of this
work, one or more of the authors received, in any one year, outside funding or
grants in excess of $10,000 from Sulzer Biologics. In addition, one or more of
the authors or a member of his or her immediate family received, in any one
year, payments or other benefits of less than $10,000 or a commitment or
agreement to provide such benefits from a commercial entity (Sulzer
Biologics). No commercial entity paid or directed, or agreed to pay or direct,
any benefits to any research fund, foundation, division, center, clinical
practice, or other charitable or nonprofit organization with which the
authors, or a member of their immediate families, are affiliated or
associated.
* The paper was read, in part, at the Annual Meeting of the Orthopaedic
Research Society, Dallas, February 2002.
Background: Clinical studies have demonstrated a high rate of
incomplete healing of rotator cuff tendon repair. Since healing of such a
repair is dependent on bone ingrowth into the repaired tendon, we hypothesized
that osteoinductive growth factors would improve rotator cuff
tendon-healing.
Methods: Seventy-two skeletally mature sheep underwent detachment of
the infraspinatus tendon followed by immediate repair. The animals received
one of three treatments at the tendon-bone interface: (1) an osteoinductive
bone protein extract on a Type-I collagen sponge carrier, (2) the collagen
sponge carrier alone, and (3) no implant. The animals were killed at six and
twelve weeks, and the repaired rotator cuff was evaluated with use of magnetic
resonance imaging, plain radiographs, histologic analysis, and biomechanical
testing.
Results: A gap consistently formed between the end of the repaired
tendon and bone in this model, with reparative scar tissue and new bone
spanning the gap. Magnetic resonance imaging showed that the volume of newly
formed bone (p < 0.05) and soft tissue (p < 0.05) in the tendon-bone gap
were greater in the growth factor-treated animals compared with the collagen
sponge control group at both time-points. Histologic analysis showed a
fibrovascular tissue in the interface between tendon and bone, with a more
robust fibrocartilage zone between the bone and the tendon in the growth
factor-treated animals. The repairs that were treated with the osteoinductive
growth factors had significantly greater failure loads at six weeks and twelve
weeks (p < 0.05); however, when the data were normalized by tissue volume,
there were no differences between the groups, suggesting that the treatment
with growth factor results in the formation of poor-quality scar tissue rather
than true tissue regeneration. The repairs that were treated with the collagen
sponge carrier alone had significantly greater stiffness than the growth
factor-treated group at twelve weeks (p = 0.005).
Conclusions: This model tests the effects of growth factors on scar
tissue formation in a gap between tendon and bone. The administration of
osteoinductive growth factors resulted in greater formation of new bone,
fibrocartilage, and soft tissue, with a concomitant increase in tendon
attachment strength but less stiffness than repairs treated with the collagen
sponge carrier alone.
Clinical Relevance: This study is the first, as far as we know, to
demonstrate the possibility of increasing tissue formation in a tendon-bone
gap with use of a biologic agent. It shows the importance of the use of
magnetic resonance imaging to evaluate the repaired tendon, since the findings
on gross observation and even histologic examination could easily be
interpreted as representing an intact repair. Further studies with use of more
clinically relevant models of tendon-bone repair may support the use of growth
factors to improve clinical outcomes.

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