Meniscal allograft transplant is a surgical procedure for restoring knee function by replacing the meniscus with cadaver allograft tissue. 

Medically Necessary:

Meniscal allograft transplantation of the knee is considered medically necessary as a treatment for patients with significant partial (more than 50%) or complete loss of the meniscus* when all of the criteria listed below are met:

*Absence of meniscus must be firmly established by previous operative reports, magnetic resonance imaging (MRI), or diagnostic arthroscopy

Not Medically Necessary:

Meniscal allograft transplantation of the knee is considered not medically necessary as a treatment for symptomatic patients with partial or complete loss of the meniscus when criteria listed above are not met.

Investigational/Not Medically Necessary:

Meniscal allograft transplantation of the knee is considered investigational/not medically necessary as a treatment for asymptomatic patients with partial or complete loss of the meniscus.

Loss of the meniscus either in part or whole, can have a poor prognosis in the long term, with the likelihood of future arthritis thought to be proportional to the amount of tissue that is torn or removed. There is growing consensus that meniscal allograft transplantation may be indicated in a narrowly defined subset of patients considered too young or active for arthroplasty and who meet specific criteria. Recent peer-reviewed research indicates the procedure is useful for carefully selected patients with persistent pain, intact articular cartilage, normal alignment, and a stable knee joint, and may offer the possibility of cartilage protection.  Short and mid-term term studies have demonstrated the effectiveness of this procedure in alleviating pain and swelling and in improving knee function. Verdonk and colleagues (2006) reported on 100 transplantations with a mean of 7.2 years. At ten years, 70% of the patients showed beneficial effects from the transplantation.

Although clinical experience has helped define indications for meniscal allograft transplantation, at this time there is still limited information on the long term results of this procedure as well as other factors that impact outcomes.  These include: the challenge in early detection of the onset of joint degeneration in patients who are known to be meniscus-deficient; lack of information on the biology of the transplanted meniscus including the process of cell migration into the meniscus during cellular re-population and the effect of an immune response on graft remodeling; and lack of information to guide rehabilitation after meniscal transplantation.

Contraindications for meniscal transplantation include those with a systemic metabolic degenerative disease, arthritis of the knees, flattening of the femoral condyles or severe degenerative changes (greater than 50% joint space narrowing, bone on bone, or erosion to subchondral bone).   Meniscal transplantation is not indicated for patients who have undergone partial or total meniscectomy and do not have symptoms or problems with their knee. It is evident that meniscal allograft transplantation is a viable option for the treatment of symptomatic patients provided rigid inclusion criteria are met.   Patients with appropriate indications should expect to do well postoperatively in terms of predictable reduction in pain and an ability to increase activity levels.  Only further study will clarify the long-term results of meniscal allografts as well as their role in preventing the progression of secondary osteoarthritis in the involved compartment.

There are two types of cartilage within the knee.  The surface or articular cartilage is teflon-like and facilitates the gliding and sliding of the bone ends upon each other.  Articular cartilage is present in all of the joints of the body.  The other type of cartilage in the knee is the meniscus, a c-shaped piece of fibrocartilage that lies between the weight bearing joint surfaces of the femur (thigh bone) and the tibia (shin bone).  There are two menisci in the normal knee; the outside one is called the lateral meniscus, the inner one the medial meniscus.  The meniscus cartilage acts as a cushion and absorbs force traveling up and down the leg and protects the surface cartilage of the knee.  The menisci also cup the joint surfaces of the femur and therefore provide some degree of stabilization to the knee.

Injuries to meniscal cartilage fall into two broad categories: traumatic tears which result from a sudden load being applied to the meniscal tissue, often from a twisting injury or blow to the side of the knee; and degenerative tears due to the natural drying out of the inner center of the meniscus that progress with age. As the meniscus becomes less elastic and compliant, a tear may occur with only minimal trauma.  A torn meniscus will usually cause pain on the side of the knee that is localized to the meniscus. Typically, low-level swelling sets in the next day after the injury and is associated with stiffness and injury.  Any twisting, squatting or impact activities will pinch the tear and cause pain. Often the pain may improve with rest and anti-inflammatory medication after the initial injury but frequently recurs with any aggressive activity. With the exception of the outermost periphery where it joins to the vascular knee lining and has a blood supply, meniscal tissue does not heal and therefore presents a clinical problem which can over time lead to cartilage damage and osteoarthritis.

For isolated tears that are unresponsive to non-operative care, operative treatment may be indicated when disabling symptoms continue.  Surgical treatment involves repairing or removing large unstable tears and is dependent on location, age and geometry of the tear, age of the patient and co-existing injury.  In general, the principle is to save the meniscus whenever possible. Repair involves roughing up the injured surfaces of the tear and placing sutures or another fixation device across the tear to keep the edges opposed to facilitate healing.  A partial meniscectomy is an operative procedure that involves trimming or removing the unstable torn portion of the cartilage, with the goal of eliminating or minimizing symptoms.

In general, significant meniscal damage can result in changes to meniscal structure and function and as a result, alteration in the alignment of the knee joint. Altered knee alignment results in re-distribution of the forces placed on the joint during normal activity, such as walking, which further damages the meniscus and articular surfaces of the femur or tibia.  Over time this damage progresses leading to destruction of the joint.

After a complete loss of the meniscus from an extended injury or repeated resections, rapid impairment of knee function occurs in most of the patients. Without therapy, osteoarthritis develops in most patients in 5 to 10 years, faster than would occur as a consequence of aging. The treatment options available after meniscal depletion are limited. To find a therapeutic solution, meniscal allograft transplantation has been performed. Meniscal replacement seeks to: 1) Reduce pain following removal of the meniscus; 2) prevent degenerative changes of the cartilage and subchondral bone after meniscus removal; 3) avoid or reduce the risk of osteoarthritis; 4) restore the mechanical properties to the joint after meniscal removal. This is a technically demanding procedure and the long-term results of the allograft in preventing the onset of degenerative changes within the knee are unknown.

This procedure is indicated, according to those who perform it, for patients who have had a previous meniscectomy, persistent pain, intact articular cartilage, normal alignment, and a stable joint. If the joint is unstable because of anterior or posterior cruciate ligament injury, these ligaments are reconstructed at the time of transplantation.  The suggested ideal candidates are young, physically active individuals with stable (or stabilizable) knees, normal alignment, and no articular surface damage (Outerbridge Grade II or less).

Contraindications for meniscal transplantation include those with rheumatoid arthritis or a systemic metabolic degenerative disease (i.e., gout), arthritis of the knees, and those who have undergone partial or total meniscectomy and do not have symptoms or problems with their knee. Obese sedentary individuals are a poor risk. Transplants tend to fail in overweight patients because of excessive weight-bearing stress on the new cartilage. Those with flattening of the femoral condyles or severe degenerative changes (greater than 50% joint space narrowing, bone on bone, or erosion to subchondral bone) are poor surgical candidates.

Proponents of this procedure state that it can slow the onset of painful, disabling arthritis and help patients to avoid or delay the need for knee replacement at a very early age, and allow them to continue working and participating in sports or fitness activities.  According to the American Academy of Orthopaedic Surgeons, in 80 to 90 percent of cases, the transplants are effective in relieving activity-related pain and swelling, although long-term results are not yet available. It is unknown whether the transplant will delay or slow the development of arthritis or other degenerational changes in the knee.

Evolving technology:

Tissue engineering is a technology based on developing biological substitutes for the repair, reconstruction, regeneration, or replacement of tissues. Its long-term goal is to construct biomaterials that are biocompatible, biodegradable, and capable of integrating molecules (e.g., growth factors) or cells. Currently, many different ceramics, polymers of lactic and glycolic acid, collagen gels, and other polymers have been tested in vitro and in vivo. More recently, genetic modifications have been included in tissue engineering to optimize the healing process. Modified cells are transplanted into injured tissue to affect the repair with the introduced gene.

Bone and cartilage are the tissues in which most tissue engineering techniques have been applied. Bone has a high potential for repair. In contrast, cartilage has a poor intrinsic capacity for healing and therefore a limited ability to regenerate. Intense investigations have focused on finding biomaterials that would be capable of repairing cartilage defects, but no efficient therapeutic approaches have yet been established; candidate materials include fibrin, collagen, ceramics, alginate, polymers of lactic and glycolic acid, hyaluronic acid, and synthetic materials. Besides bone and cartilage substitutes, biological scaffolds have been developed for other tissues of the musculoskeletal system. The collagen meniscus implant is a biological scaffold for meniscus regeneration made from bovine Achilles tendons. Early results of clinical studies are encouraging, suggesting a significant amount of meniscus regeneration with a concomitant reduction in patient symptoms, however long-term data are not yet available.

Allograft: transplantation of tissue obtained from a donor of the same species; under most circumstances in knee surgery, the donor is a cadaver

Articular: relates to the skeletal joints

Arthroscopy: procedure using a special instrument (arthroscope) that is inserted into the knee

Chondral: pertaining to cartilage

Meniscal: pertaining to the meniscus, a crescent-shaped cartilage situated in the knee

Meniscectomy: removal of the meniscus

Osteochondral: pertaining to bone and the attached articular cartilage

Osteochondritis Dissecans: a condition of uncertain etiology, which usually occurs in an active adolescent or young adult and involves separation of a fragment of the joint cartilage and underlying bone

Outerbridge Classification System:

Valgus: an abnormal position in which part of a limb is twisted outward away from the midline

Varus: an abnormal position in which part of a limb is twisted inward toward the midline

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary, when criteria are met:

CPT

ICD-9 Diagnosis

Services are Not Medically Necessary:

For the procedure code listed above, when criteria are not met for symptomatic patients.

Services are Investigational/Not Medically Necessary:

For the procedure codes listed above, for asymptomatic patients, for all other diagnoses, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

Peer Reviewed Publications:

1. Cameron ML, Briggs KK, Steadman JR. Reproducibility and reliability of the outerbridge classification for grading chondral lesions of the knee arthroscopically. Am J Sports Med. 2003, 31(1):83-86. 
2. Cole B, Carter T, Rodeo S. Allograft meniscal transplantation: background, techniques and results. American Academy of Orthopaedic Surgeons. Instr Course Lect. 2003; 52:383-96.
3. Dowdy PA, Cole BJ, Harner CD. Knee arthritis in active individuals: matching treatment to the diagnosis. The Physician and Sportsmedicine. June, 1998. 26(6).
4. Felix NA, Paulos LE. Current status of meniscal transplantation. Knee. 2003; 10(1):13-17.
5. Greis PE, Holmstrom MC, Bardana DD, Burks RT. Meniscal injury: II. Management. J Am Acad Orthop Surg. 2002; 10(3):177-187. 
6. Johnson DL, Bealle D. Meniscal allograft transplantation. Clin Sports Med. 1999 Jan; 18(1):93-108. 
7. Maitra RS, Miller MD, Johnson DL. Meniscal reconstruction Part 1: indications, techniques and graft considerations. Am J Orthop. 1999; 28(4):213-218.
8. Maitra RS, Miller MD, Johnson DL. Meniscal reconstruction. Part II: outcome, potential complications, and future directions. Am J Orthop. 1999; 28(5):280-286.
9. Mueller SM, Shortkroff S, Schneider TO, et al. Meniscus cells seeded in type I and type II collagen-GAG matrices in vitro. Biomaterials. 1999; 20(8):701-709.
10. Noyes FR, Barber-Westin SD. Irradiated meniscus allografts in the human knee: a two to five year follow up. Orthop Trans 1995; 19:417.
11. Peters G, Wirth CJ. The current state of meniscal allograft transplantation and replacement. Knee. 2003; 10(1):19-31.
12. Rankin M, Noyes FR, Barber-Westin SD, et al. Human meniscus allografts' in vivo size and motion characteristics: magnetic resonance imaging assessment under weightbearing conditions. Am J Sports Med. 2006; 34(1):98-107.
13. Rath E, Richmond JC, Yassir W, et al. Meniscal allograft transplantation: two- to eight-year results.  Am J Sports Med. 2001; 29(4):410-414.
14. Rodeo SA, Seneviratne A, Suzuki K, et al. Histological analysis of human meniscal allografts. J Bone Joint Surg Am. 2000; 82-A(8):1071-1081.
15. Rodeo SA. Meniscal allografts--where do we stand? Am J Sports Med. 2001; 29(2):246-261.
16. Rodkey WG, Steadman JR, Li ST. A clinical study of collagen meniscus implants to restore the injured meniscus. Clin Orthop. 1999; (367 Suppl):S281-92.
17. Ryu RK, Dunbar V WH, Morse GC. Meniscal allograft replacement: a 1 year to 6 year experience. Arthroscopy. 2002; 18(9):989-994.
18. Sekiya JK, Ellingson CI. Meniscal allograft transplantation. J Am Acad Orthop Surg. 2006; 14(3):164-174. 
19. Stollsteimer GT, Shelton WR, Dukes A, et al. Meniscal allograft transplantation: A 1- to-5 year follow-up of 22 patients.  Arthroscopy. 2000; 16(4): 343-347.
20. Van Arkel ER, de Boer HH. Survival analysis of human meniscal transplantations. J Bone Joint Surg Br. 2002; 84(2):227-231.
21. Van Arkel ER, Goei R, de Ploeg I, de Boer HH. Meniscal allografts: evaluation with magnetic resonance imaging and correlation with arthroscopy. Arthroscopy. 2000; 16(5):517-21.
22. Verdonk PC, Demurie A, Almqvist KF, et al. Transplantation of viable meniscal allograft. Surgical technique. J Bone Joint Surg Am. 2006; 88 Suppl:109-118. 
23. Verdonk R. Meniscal transplantation. Acta Orthop Belg. 2002; 68(2):118-27.
24. Wirth CJ, Peters G, Milachowski KA, et al. Long-term results of meniscal allograft transplantation. Am J Sports Med. 2002; 30(2):174-181.
25. Yoldas EA, Sekiya JK, Irrgang JJ, et al. Arthroscopically assisted meniscal allograft transplantation with and without combined anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2003; 11(3):173-182.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Orthopaedic Surgeons. Meniscal transplants. Available at: http://orthoinfo.aaos.org/fact/thr_report.cfm?Thread_ID=414&topcategory=Knee&all=all. Accessed on December 30, 2006.
2. Australian Safety and Efficacy Register of New Interventional Procedures – Surgical. New and Emerging Techniques – Surgical. Procedure brief. Meniscal transplantation. November 2001. Available at:  http://www.surgeons.org/. Accessed on December 30, 2006.
3. Hayes Inc. Hayes Medical Technology Directory. Meniscal allograft. Lansdale, PA: Hayes, Inc. April 5, 2004. Search updated June 13, 2006.
4. Feinberg, SB (2000). The Knee: Meniscal injuries & treatment. Removal, repair, transplantation & regeneration. CWCE Magazine for the Workplace Community. Available at:  http://www.cwce.com/feinbergarticles/meniscustrans.htm. Accessed on December 30, 2006.
5. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Questions and answers about knee problems. Available at: http://www.niams.nih.gov/hi/topics/kneeprobs/kneeqa.htm. Accessed on December 30, 2006.

Allograft Transplantation

Meniscal Allograft Transplantation

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