July_AMP_Digital

A D V A N C E D

M A T E R I A L S

P R O C E S S E S | J U L Y / A U G U S T

2 0 1 6

2 1

For more information:

David Spen-

ciner, FASM, is a research fellow, DePuy

Synthes, Mitek Sports Medicine, 325

Paramount Dr., Raynham, MA 02767,

508.828.3721,

dspencin@its.jnj.com

depuysynthes.com. Co-authors include

Dennis Burke and Samir Bhattacharyya.

References

1. J.L. Basko-Piluska, J.P. Thyssen, et al.,

Cutaneous and Systematic Hypersen-

sitivity Reactions to Metallic Implants,

Dermatitis,

V 22(2), p 65-79, 2011.

2. A. Weiler, R.F. Hoffmann, et al., Bio-

degradable Implants in Sports Medi-

cine: The Biological Base,

Arthroscopy,

V 16 (3), p 305-21, 2000.

3. J.M. Brady, D.E. Cutright, et al.,

Resorption Rate, Route of Elimination,

and Ultrastructure of the Implant Site

of Polylactic Acid in the Abdominal

Wall of the Rat,

J. Biomed Mater. Res.,

V 7 (2), p 155-66, 1973.

4. F.A. Barber and W.D. Dockery, Long-

Term Absorption of Poly-L-Lactide Acid

Interference Screws,

Arthroscopy,

V 22 (8), p 820-6, 2006.

5. T. Poandl, S. Trenka-Benthin, et al.,

A New Faster-Absorbing Biocomposite

Material: Long-Term In-Vivo Tissue

Reaction and Absorption, poster pre-

sentation, Spring AANA, May 2005.

6. F.A. Barber and S.A. Hrnack, Poly

L-Lactide Co-Glycolide/

-Tricalcium

Phosphate Interference Screw Fixation

for Bone-Patellar Bone Anterior Cruci-

ate Ligament Reconstruction,

J. Knee

Surg.,

V 26, p 423-8, 2013.

7. P. Randelli and R. Compagnoni,

et al., Long-Term Degradation of a

Poly-Lactide Co-Glycolide/

-Tricalcium

Phosphate Biocomposite Anchors in

Arthroscopic Bankart Repair: A Pro-

spective Study,

Arthroscopy,

V 30 (2),

p 165-71, 2014.

8. H.E. Bourke and L.J. Salmon, et al.,

Randomized Controlled Trial of Osteo-

conductive Fixation Screws for Anterior

Cruciate Ligament Reconstruction: A

Comparison of the Calaxo and Milagro

Screws,

Arthroscopy,

V 29 (1): p 74-82,

2013.

9. F.A. Barber, W.D. Dockery, et al., The

Degradation Outcome of Biocomposite

Suture Anchors made from Poly L-

Lactide Co-Glycolide and

-Tricalcium

Phosphate,

Arthroscopy,

V 29 (11),

p 1834-9, 2013.

completely absorbed and in most

cases, boney ingrowth follows in the

timeframe of approximately 2–3 years.

In addition, implants made of this

material do not cause adverse effects

such as cyst formation or soft-tissue

inflammatory reactions. For exam-

ple, one prospective clinical study

concluded, “Anchors made of 30%

-tricalcium phosphate and 70% PLGA

showed excellent biological efficacy,

without causing significant cyclic

lesions, producing gradual changes in

the MR signal that seems to become

equivalent to that of the glenoid tra-

becular bone at a mean of 29 months

after implantation.”

[7]

However, not

all biocomposite materials were as

successful, with one of these clini-

cal studies halted prematurely when

the other biocomposite material was

pulled from the market by the manu-

facturer due to “pretibial soft-tissue

swelling”

[8]

CONCLUSION

With a 12-year history of use in

humans, Biocryl Rapide remains state-

of-the-art in terms of orthopedic sports

medicine applications. Multiple pre-

clinical and clinical studies have shown

BR to be sufficiently strong for specific

orthopedic applications while almost

fully absorbing in an appropriately

short timeframe. Further, these studies

show that BR promotes formation of

new bone to backfill the volume that

was previously inhabited by the im-

plant.

~AM&P

Fig. 5 —

Stress vs. strain plots for BR at room temperature (27°C) vs. body temperature (37°C).

Fig. 6 —

Histologic sections of rods (white) in bone (stained red using a hematoxylin and eosin

stain) show degradation profiles over 24 months

[5]

0 1 2 3 4 5 6 7 8 9 10

Strain, %

Stress, MPa