Surgery Section - Meniscal Allograft Transplantation

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

Historically, the role of normal meniscal cartilage was greatly under appreciated and up until some 30 years ago, torn and damaged menisci were routinely excised. However, it is now known that the menisci are integral structural components of the human knee, functioning to absorb shocks, provide joint stability, congruity, and nutrition. In addition, total and partial meniscectomies are associated with altered load bearing across the joint, frequently resulting in degenerative osteoarthritis. The integrity of the menisci is particularly important in knees in which the anterior cruciate ligament (ACL) has been damaged; in these situations, the menisci act as secondary stabilizers of anteroposterior and varus-valgus translation. With this greater understanding, the surgical principles of treating torn or damaged menisci evolved to their repair and preservation whenever possible. Moreover, meniscal allograft transplantation has been investigated in patients with a previous meniscectomy or in patients requiring total or near total meniscectomy for irreparable tears.

There are three general groups of patients who have been treated with meniscal allograft transplantation:

• Those with pain and discomfort associated with early osteoarthrosis
• Those who are undergoing ACL reconstruction in whom a concomitant meniscal transplant is intended to provide increased stability
• Athletes with few symptoms in whom the allograft transplantation is intended to deter the development of osteoarthritis

Cartilage damage in the knee may be described by the Outerbridge classification system:

The following different types of allografts have been investigated:

• Fresh

Fresh implants, harvested under sterile conditions, typically are not a practical option. The grafts must be used within a couple of days to maintain viability. Also, there are concerns regarding infectious diseases, such as HIV, and the grafts must be appropriately sized.

• Frozen

After sterile harvest, the meniscus can be frozen for storage until thawed for use. The freezing process may destroy donor cells and decrease the size of the graft.

• Freeze Dried (Lyophilized)

In addition to freezing, the tissue may be dehydrated, permitting storage at room temperature. Before transplantation, the graft is thawed and rehydrated.

• Cryopreserved

Cryopreservation freezes the graft in glycerol, preserving the cell membrane integrity and donor fibrochondrocyte viability. Of all the above options, cryopreserved grafts are most commonly used. Cryolife (Marietta, GA) is a commercial supplier of such grafts.

The risk of infectious disease, particularly HIV or hepatitis, continues to be a concern. Several secondary sterilization techniques have been used, with gamma irradiation being the most common.

Policy/Criteria

1. Meniscal allograft transplantation may be considered medically necessary in patients who have had a prior meniscectomy and have symptoms related to the affected side, when all of the following criteria are met:
   1. Adolescent patients should be skeletally mature with documented closure of growth plates (e.g., 15 years or older). Adult patients should be too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., younger than 55 years).
   2. Absence or near absence (more than 50%) of the meniscus, established by preoperative imaging or prior surgery.
   3. Disabling, refractory knee pain that meets both of the following criteria:
      1. Severe knee pain that results in functional limitations and impaired activities of daily living
      2. Refractory to conservative treatment (e.g.  NSAID, analgesics, intraarticular injection, exercise, assistive devices, bracing)
   4. Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge Grade II or less)
   5. Normal knee biomechanics, or alignment and stability achieved prior to or concurrently with meniscal transplantation
   6. There is no infection, inflammatory arthritis or synovial disease present
   7. Body mass index (BMI) less than 35
2. Meniscal allograft transplantation is considered investigational when performed in combination, either concurrently or sequentially, with autologous chondrocyte implantation or osteochondral allografting.

Position Summary

While long-term efficacy and safety have not been established, meniscal allograft transplantation may benefit carefully selected patients.

Efficacy

Meniscal allograft transplantation (MAT) performed in combination with other surgical interventions may improve symptoms in some patients with a prior meniscectomy who are considered too young to undergo total knee replacement.  Short-term results of meniscus transplantation are encouraging.

• For example, Cole and colleagues reported follow-up evaluation of 39 patients, 21 menisci were transplanted in isolation, and 19 were combined with other procedures.(2)  From the whole group, four transplants (three patients) failed early and another seven had failed at follow-up, for a total 25% failure rate. The authors conclude that, “meniscus transplantation alone or in combination with other reconstructive procedures results in reliable improvements in knee pain and function at minimum 2-year follow-up.

The long-term safety and effectiveness have not been established. It is unknown whether MAT can delay or prevent the progression of degenerative changes and joint space narrowing.

• Procedures are still evolving and meniscal allograft transplantation lacks general consensus regarding indications, tissue processing, secondary sterilization and surgical technique. (2,3)
• The scientific evidence does not permit conclusions concerning the effect of meniscal transplantation on the progression of degenerative changes and joint space narrowing (3-5)

A 1997 BlueCross BlueShield Association Technology Evaluation Center (TEC) assessment noted that the data regarding meniscal allograft transplantation are of poor quality. (6) For example, none of the studies reporting health outcomes included preoperative and postoperative measures of restoration of knee function, including MRI results or second-look arthroscopy. None of the studies presented clear comparisons of preoperative clinical findings to postoperative results. Each study assessed outcomes differently. While definitive data was not available, in general, poor results were reported in patients with Outerbridge grade III or IV osteoarthritis, or in those with unstable knees, and thus researchers have largely abandoned meniscal allograft transplantation in these patients.

The literature published since 1997 does not address the limitations identified in the TEC assessment.

• In terms of the intermediate outcome of graft viability, the largest case series data has been collected by CryoLife, a commercial supplier of cryopreserved allografts. (7) However, these data are not available in the published peer-reviewed literature.

Long-term data has reported mixed outcomes.

• Hommen and colleagues reported 10-year follow-up on 20 out of 22 (91%) consecutive patients who received cryopreserved meniscus allografts.(3) The 10-year graft survival/success rate was 45%. Out of 15 patients with follow-up radiographs, 10 (67%) had narrowing (from 5.2 mm at baseline to 4.0 mm at follow-up) and 12 (80%) had progression of the Fairbank degenerative joint disease score.  Twenty-year follow-up was reported for five patients who had received a deep frozen meniscal allograft along with other procedures on the knee. (5) At 20-year follow-up MRI revealed shrinkage of the transplants with very small rims of the meniscus, the remaining meniscal tissue showed degenerative changes.
• Verdonk and colleagues reported long-term follow-up from 100 of their first 105 (95%) fresh cultured meniscal allografts performed from 1989-2001.(8) At ten years, 70% of the allografts survived; the mean survival time was estimated at 11.6 years.
• Verdonk and colleagues also published follow-up of at least ten years with radiological imaging from their first 42 allografts. (9) Of the 41 patients, seven (17%) were followed up at the time of total knee replacement (failures); these were characterized by progression in joint space width narrowing (by 1 or 2 grades) and Fairbank changes (by 1 or 2 grades). Twenty-five allografts were evaluated in 2004 (average of 12 years follow-up). Of the 32 total cases evaluated (76% follow-up), joint space remained stable in 41% (13 of 32 knees) and Fairbank changes did not progress in 28% (9 of 32 knees). Magnetic resonance imaging (MRI) showed absence of further femoral cartilage degeneration in 8 of 17 knees (47%) evaluated. Of interest, no significant correlations were found between any of the measured radiological or MRI parameters and clinical outcome sub scales.

Safety

It is unknown whether meniscal allograft transplantation improves overall health outcomes in comparison with correctin of malalignment and/or ligamentous instability alone.

MAT is associated with frequent complications, including tears of the transplanted meniscus, displacement, or arthrofibrosis.

• Hommen and colleagues reported 10-year follow-up on 20 out of 22 (91%) consecutive patients who received cryopreserved meniscus allografts. (3) Forty additional surgical procedures were performed on 17 patients (85%) after transplantation; these included manipulation under anesthesia, arthroscopic synovectomy for postoperative arthrofibrosis, and additional meniscus-related procedures. The 10-year graft survival/success rate was 45%, with 5 allograft failures.
• In a 2007 meta-analysis that included 15 studies, up to 26% reoperation rates for allograft tears in addition to other complications were reported (10)

MAT is a difficult procedure that has not been demonstrated to be effective outside of a specialized/investigational setting. One review concluded that success for meniscal transplantation depends on performing the procedure with appropriate indications, using appropriate-sized menisci and meticulous technique. (5) Another states that “patients who meet criteria for meniscus allograft but have instability, malalignment or focal cartilage defects, may be candidates for transplantation as well as procedures to correct associated pathology. Such major interventions must, at present, be considered salvage procedures, and we do not recommend that they be performed casually or by surgeons without extensive experience and expertise in complex knee reconstruction.” (11)

References

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.15
2. TEC Assessment; Meniscal Allograft Transplantation; 1997; BlueCross and  BlueShield Association Technology Evaluation Center , Vol 12, Tab 14
3. Johnson DL, Bealle D. Meniscal allograft transplantation. Clin Sports Med 1999;18(1):93-108
4. CryoLife Web Site:  www.cryolife.com/products/ortho_meniscusnew.htm  (Verified 09/22/08)
5. Rath E, Richmond JC, Yassir W et al. Meniscal allograft transplantation. Two- to eight-year results. Am J Sports Med 2001;29(4):410-4
6. Wirth CJ, Peters G, Milachowski KA et al. Long-term results of meniscal allograft transplantation. Am J Sports Med 2002;30(2):174-81
7. Noyes FR, Barber-Westin SD, Rankin M. Meniscal transplantation in symptomatic patients less than fifty years old. J Bone Joint Surg Am 2004;86-A(7):1392-404
8. Noyes FR, Barber-Westin SD, Rankin M.  Meniscal transplantation in symptomatic patients less than fifty years old.  J Bone Joint Surg Am  2005;87 Suppl 1(pt 2):149-65
9. Sekiya JK, Giffin JR, Irrgang JJ, et al. Clinical outcomes after combined meniscal allograft transplantation and anterior cruciate ligament reconstruction. Am J Sports Med 2003;31(6):896-906
10. 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):173-82
11. Verdonk PC, Demurie A, Almqvist KF et al. Transplantation of viable meniscal allograft. Survivorship analysis and clinical outcome of one hundred cases. J Bone Joint Surg Am 2005; 87(4):715-24
12. Verdonk PC, Verstraete KL, Almqvist KF et al. Meniscal allograft transplantation: long-term clinical results with radiological and magnetic resonance imaging correlations. Knee Surg Sports Traumatol Arthrosc 2006; 14(8):694-706
    
13. Sekiya JK, West RV, Groff YJ, et al. Clinical outcomes following isolated lateral meniscal allograft transplantation. Arthroscopy 2006; 22(7):771-80
14. Sekiya JK, Ellingson CI. Meniscal allograft transplantation. J Am Acad Orthop Surg. 2006; 14(3):164-74
    
15. Cole BJ, Dennis MG, Lee SJ, et al. Prospective evaluation of allograft meniscus transplantation: a minimum 2-year follow-up. Am J Sports Med 2006; 34(6):919-27
16. Heckmann TP, Barber-Westin SD, Noyes FR. Meniscal repair and transplantation: indications, techniques, rehabilitation, and clinical outcome. J Orthop Sports Phys Ther 2006 Oct;36(10):795-814
17. Eriksson E. Meniscus transplantation. Knee Surg Sports Traumatol Arthrosc 2006; 14(8):693
18. Matava MJ. Meniscal allograft transplantation: a systematic review. Clin Orthop Relat Res 2007;455:142-57
19. Hommen JP, Applegate GR, Del Pizzo W. Meniscus allograft transplantation: ten-year results of cryopreserved allografts. Arthroscopy 2007;23(4):388-93
20. von Lewinski G, Milachowski KA, Weismeier K et al. Twenty-year results of combined meniscal allograft transplantation, anterior cruciate ligament reconstruction and advancement of the medial collateral ligament. Knee Surg Sports Traumatol Arthrosc 2007;15(9):1072-82
21. Amendola A.  Knee osteotomy and meniscal transplantation: indications, technical considerations, and results. Sports Med Arthrosc 2007;15(1):32-8
22. Lubowitz JH, Verdonk PC, Reid JB 3rd et al. Meniscus allograft transplantation: a current concepts review. Knee Surg Sports Traumatol Arthrosc 2007;15(5):476-92

Cross References

Autologous Chondrocyte Implantation, Regence Medical Policy Manual, Surgery, Policy No. 87

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