Allograft Patients
Nearly two million Americans annually undergo orthopedic and spinal surgical procedures resulting from active lifestyles, trauma, common back pain and the effects of degenerative diseases - all procedures that could be made safer by the Clearant Process®.1

An increasingly common procedure
Biological products processed for implantation include soft tissues such as ligaments and tendons as well as hard tissue like bone. The incidence of today's implantation procedures includes:
• 299,000 total knee replacement surgeries in 2000 2
• 152,000 total hip replacement surgeries in 2000 3
• 211,300 anterior cruciate ligament (ACL) repairs in 2001 4
• 325,000 spinal fusion surgeries in 2001, including lumbar and cervical fusions 5

To learn specifically about anterior cruciate ligament (ACL) reconstruction, click here.

Most of the 700,000 ligament and tendon procedures in 2001 involved the use of autografts.6 An autograft is tissue or bone taken directly from the patient's own body. Although the tissue is compatible with the recipient (since he or she is their own donor), autografts require a second surgical site to harvest the tissue. For the patient, this generally means increased time in surgery, increased morbidity (an increase in pain and discomfort), longer recovery time and increased scarring. Not only that, but the healthy site, where the autograft is extracted, is weakened in the process.

What is an allograft?
A newer advance in implantation surgery is the growing use of allografts. Allograft procedures use tissues harvested from a living or deceased donor. The donated tissue is then processed and prepared for implantation. Although allografts offer several advantages over autografts (including a single surgical site, reduced discomfort and post operative problems, decreased recovery times, and increased availability), there is an important safety concern that has impeded wider usage of allograft tissue: the challenge of significantly inactivating pathogens in the donated tissue.

What are the risks?
The Centers for Disease Control and Prevention (CDC) investigated 54 cases of bacterial transmission through allografts; one of which resulted in death.7 In the summer of 2002, the CDC investigated 40 patients who had received organs and tissue from a donor infected with Hepatitis C.8 Click here to view an August 2003 presentation by the CDC.

While the risks of receiving a contaminated allograft are small, there have been reported cases of infections which have resulted in death or altered patient lives permanently. In some cases, patients who have gone in for routine orthopedic surgery, emerge not being able to play their favorite sports, run or accomplish normal tasks required at their jobs. These problems have not been due to the surgical procedure but rather, the result of an infection caused by an implanted allograft.

What is the solution?
Clearant is proud to introduce the Clearant Process® — a pathogen inactivation technology that substantially reduces all types of pathogens that may be present in allograft tissue.

The Clearant Process® is the only current pathogen inactivation technology designed to be used for allograft tissue in the final container; making the product ready for use in the operating room.

That means patients enjoy peace of mind knowing the products used in their treatments are safer from potentially life-threatening pathogens-and doctors are empowered to provide care with confidence as they treat patients with products processed with a more powerful, safer and robust technology.

"This is the allograft of choice" – Dr. Ty Endean, M.D., Sports Institute of Tucson

Rigorous testing every step of the way

Mechanical testing in the laboratory, along with clinical experience, have demonstrated the safety and efficacy of Clearant Process-treated allografts. The Clearant Process has been successfully applied to and tested on Achilles tendon, semitendinosis tendon, bone-patellar tendon, tibialis tendon, hemi-patellar ligament, and human fascia.

Tissue treated with the Clearant Process...

• Ensures the sterility level of a medical device while protecting biomechanical integrity.
• Destroys the widest range of bacteria and viruses, including West Nile Virus, HIV, Hepatitis A and Hepatitis C.
• Preserves stuctural and functional integrity and biologic activity.
• Increases safety assurance as the only terminal process applied to tissue products in the final operating-room-ready packaging.

1 Medtech Insight 2002.
2,3 National Hospital Discharge Survey 200, US Dept of Health & Human Services.
4,5,6 Medtech Insight.
7 Update: Allograft Associated Bacterial Infections", Mortality and Morbidity Weekly Report, Centers for Disease Control, March15, 2002/51(10);207-210; "Hospital Deaths - Concern growing over tissue graft infection" Associated Press, July 21, 2002.
8 "40 People Unknowingly Got Tissue or Organs from Donor with Hepatitis C; 5 Died" New York Times, October 1, 2002, Sandra Blakeslee.

Achilles, semitendinosis, hemi-patella with blocks, tibial tendons

Sports medicine – Soft tissue allografts

Pre-Shaped, Hemi-Patella Bone dowels are pre-shaped to 10mm x30mm the inner tendon length varies per surgeon request.

Semi-T

Whole Patella

Posterior Tibialis

Anterior Tibialis

Measurements over time indicate the Clearant Process® comparable to fresh-frozen tissue.

Tegner Score: Post-op patient activity significantly improved.

Effusion Data: Post-op effusion levels comparable to fresh-frozen tissue.

One-Leg Hop Test: Strength of post-op compares favorably with non-surgical knee.

Results: Positive physical, emotional and mental health of post-of Clearant Process® patients reflected through all categories. Post-op patient activity significantly improved.