2001 Meniscus Transplantation Study Group

March 1, 2001, 3 p.m. - 6 p.m.
Sheraton Palace - Twin Peaks Room
Two Montgomery Street
San Francisco CA 94105
Phone: 415-512-1111

This meeting took place during the AAOS convention in San Francisco.

Thank you to our meeting sponsors:
the medcom group, ltd.
The Stone Foundation for Sports Medicine and Arthritis Research

Agenda

INTRODUCTION 3:00 p.m.
 
Cryolife Data on the Current Status of Meniscus Allografting in the U.S. and Plans for the Future
David M. Fronk, M.S.
Cryolife, Inc., Kennesaw, Georgia
3:10 p.m.
 
Protective Effects Of Meniscal Allografts
Mora G*., Forriol F**., Ripalda P.**, Alvarez E**.
*Instituto COT. Clinica Quiron. Valencia. SPAIN
**Orthopaedic Research Laboratory. University of Navarra. SPAIN
3:25 p.m.
 
Meniscal Allografts - Indications in patients with grade IV articular cartilage changes
Mohi El-Shazly, M.D.
Droitwich Knee Clinic, Droitwich Spa, England
3:40 p.m.
 
Is DNA Fingerprinting a Tool in Evaluating the Success Rate of Viable Meniscal Allografting?
Karl F. Almqvist, M.D., T. Lootens, René Verdonk, M.D.
Department Of Physical Medicine And Orthopaedic Surgery
University Hospital Of Ghent, Gent, Belgium
3:55 p.m.
 
Meniscal Lesion Repair After Implantation of New Porous Polymers. A Study in Dogs
T.G. van Tienen, P. Buma, R.G.J.C. Heijakants*, N.G. Lieuwes, J.H. de Groot*, R.P.H. Veth
Orthopaedic Research Laboratory, University Medical Centre, Nijmegen, The Netherlands
*Plymer Chemistry, University of Groningen, The Netherlands.
4:10 p.m.
 
Update on Meniscal Allografting in Arthritic Knees
Kevin R. Stone, M.D., Ann Walgenbach, R.N., M.S.N, N.P.
The Stone Clinic, San Francisco, CA
4:25 p.m.
 
Porcine Xenografts for Orthopaedic Applications
Stone KR, Walgenbach AW, Turek TJ, Galili U
CrossCart, Inc., San Francisco, CA
4:40 p.m.
 
Advances in the Basic Science of the Normal and Remodeling Meniscus
Cahir McDevitt, Ph.D**
Biomedical Engineering, Lerner Research Institute, Cleveland Clinic Foundation
4:55 p.m.
 
The Future of Meniscal Transplantation and Replacement in Europe
Henrik Aagaard, M.D., Ph.D
Department of Orthopaedic Surgery
RASK Koege, Denmark
5:15 p.m.
 
Combined Meniscal Transplant and ACL Reconstruction
Christopher Harner, M.D.**
University of Pittsburg Medical Center, Center for Sports Medicine
5:30 p.m.
 
The Present Status and Future of Meniscal Transplantation
Allan E. Gross, M.D., F.R.C.S.
Mt. Sinai Hospital, University of Toronto, Canada
5:45 p.m.
 
Presentations to be eight minutes followed by discussion.
**Presentation to be twelve minutes followed by discussion.

Abstracts

CryoLife Data on the Current Status of Meniscal Allografting in the United States

Authors: D.M. Fronk, M.S., J.D. Lehman, B.S.
CryoLife Inc., Kennesaw, Georgia

Introduction: CryoLife's first meniscal allograft was implanted in November of 1989. Since then, over 3500 grafts have been provided for implant. These grafts have been implanted by over 450 surgeons throughout the U.S. In the early stages of meniscus reconstruction, clear indications of the procedure had yet to be shown. Through an initial study, those parameters were set to clearly identify future candidates for meniscal reconstruction. The purpose for this study was to provide clinical outcome data evaluating the mid-term performance of cryopreserved meniscal allografts.
Methods: One hundred thirty-six patients with a mean age of 35 (range 17-58) were retrospectively reviewed based on objective and subjective data obtained through a patient mailing. Thirteen surgical sites were included. Clinical outcome was assessed using a quality of life questionnaire including a modified version of the Lysholm activity scoring system.
Results: The range of follow-up was from 36-96 months (mean 5.1 years). The average post-operative Lysholm score was 79 ± 18 with 80% of patients rating their current knee function as normal or nearly normal. The average post-operative pain level was rated low at an average of 2.7 on a 10-point scale. Ninety percent of patients reported their surgery as a success, while 93% reported that they would have the surgery again if presented with the same situation. There was a 76% good to excellent result of those patients at >5 years follow-up.
There was an 86% success rate based on re-operation. A total removal was indicated in 6 patients with a partial removal in 14 patients. Six of 7 partial removals were performed on patients with pre-operative Fairbanks changes of Stage III & IV with 4 of the same patients presenting with Grade IV Outerbridge changes.
Conclusion: Meniscus reconstruction using cryopreserved meniscus allografts is shown to have successful mid-term results in most patients who have indications of isolated pain, no greater than Stage II Fairbanks or Grade IV Outerbridge changes at the time of surgery, and who have previously undergone a total or partial meniscectomy.

Is DNA Fingerprinting a Tool in Evaluating The Success Rate of Viable Meniscal Allografting?

Authors: K.F. Almqvist, T. Lootens, R. Verdonk.
Department of Physical Medicine and Orthopaedic Surgery,
University Hospital of Ghent, Gent, Belgium.

Aim of the study: Meniscal allografting has been reported to allow for slow integration of recipient fibrochondrocytes into the transplanted meniscal tissue. The integration of recipient fibrochondrocytes into human viable meniscal allografts was evaluated in this study.
Methods: 21 of 98 patients who had received an allogenic viable meniscal transplant, underwent a control arthroscopy. A biopsy specimen was harvested from the implanted menisci during this second operation. DNA fingerprinting was performed to evaluate possible ingrowth of the meniscal allograft by acceptor fibrochondrocytes.
Results: The compared DNA region showed complete matching in 7 cases, incomplete matching (cell population of the recipient and the donor) in 4 cases, and non-matching in 3 cases. The remaining 5 cases could not be analyzed due to culture failure. Two patients underwent a second arthroscopy. The initial DNA determination was mixed and non-matching, and at the second arthroscopy this became matching and mixed DNA pattern, respectively.
Conclusion: These findings suggest partial or complete ingrowth of the transplanted meniscus by acceptor fibrochondrocytes. However, non-matching does not imply a graft failure as evidenced by a simultaneous clinical examination using the Hospital for Special Surgery score, and by the macroscopic aspect during control arthroscopy. MRI performed prior to control arthroscopy and pathological examination of the retrieved fragment both showed a certain degree of mucoid degeneration in case of a non-matching DNA pattern.

Protective Effects Of Meniscal Allografts

Authors
Mora G*., Forriol F**., Ripalda P.**, Alvarez E**.
*Instituto COT. Clinica Quiron. Valencia. SPAIN
**Orthopaedic Research Laboratory. University of Navarra. SPAIN

Objective: To quantify histologic changes of articular cartilage after medial meniscectomy and after medial meniscectomy followed by immediate reconstruction with meniscal allograft or Aquiles tendon allograft, with reference to the development of degenerative arthritis.
Methods: Three groups of eight sheep each were used for the study. (1) meniscectomy, (2) meniscal allografts and (3) Aquiles tendon allograft. Horns of the reconstructed menisci were secured with non-absorbable transosseous sutures and absorbable sutures were used for the body of the menisci. Animals were euthanized after 6 months and articular cartilage was histologically studied according to Mankin's score for osteoarthritis.
Results: Significant differences were found among all the groups with the highest score in meniscectomy (worst) and lowest score in meniscal allograft reconstruction (best) although changes were always found compared to a normal (control) knee.
Conclusions: Meniscal transplantation provides protection, although not complete, against damage to the articular cartilage after a meniscectomy.

The Present Status and Future of Meniscal Transplantation

Author: Allan E. Gross M.D., F.R.C.S.(C)
Mt. Sinai Hospital
University of Toronto

Experimental meniscal transplantation in rabbits has been performed to evaluate the healing response of free meniscal allografts. Fresh, frozen, and frozen irradiated allograft menisci were inserted with interrupted sutures. Macroscopic, microscopic, biochemical and viability studies were performed. Meniscal allografts healed peripherally. The donor cells died and the meniscus was repopulated by host cells within six months. Tritiated cytidine radiography revealed that fresh allografts started with 90 % viable cells, while frozen cryopreserved menisci had 4% viable cells. Even in fresh grafts by two months, most cells died and repopulation was necessary. During the period of cell repopulation the menisci remained structurally intact. There was a mild immune response to allograft tissue compared to autograft menisci. Overall experimental meniscal transplantation by many investigators has supported the clinical use of meniscal allografts.
From 1972 to 1992, 126 osteochondral allografts were carried out for post traumatic defects of the knee. As part of that series 47 meniscal allografts were performed as part of a composite osteochondral plateau graft for trauma. There was an 85% success rate for the entire series at an average follow up of 7.5 years. There was no relationship between failure and the need for meniscal allograft. In a more recent study of 60 knees that had received fresh femoral condylar allografts for traumatic defects, 10 meniscal allografts were transplanted. At a mean follow up of 10 years there was an 85% survival with patients requiring a meniscal transplant doing as well as those that did not. Arthroscopic examination of 10 allograft menisci at an average follow up of 4.5 years revealed structurally intact menisci with some degenerative changes and viable cells.
The issues to be considered for the future for meniscal transplantation are the indications, preparation, sizing, surgical technique and evaluation. The potential indications are the post menisectomy early arthritic knee with or without an osteotomy, the post menisectomy knee undergoing ligament reconstruction, fresh meniscal tears that cannot be repaired and the meniscus as part of an osteochondral allograft. In our experience fresh tissue does best but the logistics are more difficult and there is the risk of disease transmission. Plain x-rays are adequate for sizing the medial meniscus but C.T. or M.R.I. is more accurate for the lateral meniscus. In our series direct suturing was used but other authors advocate bone blocks. Evaluation of meniscal allografts should be done by arthroscopic examination and biopsy.

Meniscal Allografts - Indications in Patients with Grade IV Articular Cartilage Changes

Authors: Strover AE, El-Shazly M
Droitwich Knee Clinic, Droitwich Spa, UK

Introduction: The function of the meniscus has been well documented in recent years, mainly following long-term follow-up of patients who had total meniscectomies in the past. The consequences of meniscectomy in these patients include osteoarthritic change due mainly to high contact stresses developed in the absence of the meniscus.
A number of recent studies have shown gratifying short-term results of meniscal allografts. The objective of meniscal allograft transplantation is relief of pain and improvement of function. By restoring joint mechanics it should also prevent long-term arthritic degeneration. While relief of pain is achieved in most cases, its effect on prevention of degenerative joint disease has not been shown. The procedure is generally recommended for patients with little or no joint surface damage
We report on the short-term results of meniscal allografts performed for a small cohort of patients most of whom had significant long standing joint surface damage.
Material & Methods: In the period from May 1996 to June 2000, 12 meniscal transplants in 10 patients performed at the Droitwich Knee Clinic, were monitored prospectively. Age ranged from 19 to 53 years (mean 33.3). There were two females and eight males. There were six medial and six lateral menisci. Mean follow-up period was 24.6 months (range 6 to 53 months). Most were secondary or tertiary referrals, with a mean of 3.6 previous procedures (range 2 - 9), and a mean time from onset of symptoms of 9.3 years (2.5 - 14 y). Seven of the ten patients had articular surface changes (grade II - IV).
Each patient filled out a detailed preoperative questionnaire, from which a pre-operative Lysholm score and Tegner activity rating was derived. Postoperatively, patients were asked to fill out a follow-up questionnaire at six months, 1 year and yearly thereafter. The forms included detailed questions on symptoms including the Borg scale for pain (0 - 10), the presence of mechanical symptoms such as locking or giving way. Postoperative Lysholm and Tegner scores were recorded as well as the IKDC system. A thorough clinical examination was performed at each time point particularly recording the presence and size of any effusion, joint line tenderness and range of motion. Isokinetic testing was used to monitor improvement in muscle function prior to return to sporting activity.
Second look arthroscopy was performed routinely at three months for all patients. Pre and postoperative X-rays and MRI scans were analysed.
Results: Pain was the main pre-operative symptom in all cases with a mean value of 5.3 on the Borg scale (range 3 to 8). Seven patients had recurrent or persistent effusion and 5 cases had mechanical symptoms such as locking or giving way.
The mean pre-injury Tegner rating was 8 (range 3 - 9). Mean pre-operative scores were 2 (0 - 5). At a mean follow up of 24 months, the mean Tegner rating had improved to 3.2 (0 - 4). Three patients had no improvement on preoperative activity. Another two were worse and the rest had improved (overall mean improvement of 1.3 Tegner grades).
Lysholm scores improved from a preoperative mean of 63.3 (range 29 - 95) to 76.4 (48 - 99) postoperatively.
Of the 9 patients who filled out their subjective IKDC questionnaire, 5 (56%) rated their knee as nearly normal. 3 as abnormal and 1 remained severely abnormal.
Improvement in pain however was disappointing with a mean preoperative Borg score of 4.6, which improved to 3.5 postoperatively.
Discussion: Contrary to recommendations in the literature this study includes patients who have been referred with long standing problems, including multiple operative procedures in the past and grade IV changes affecting the weight-bearing surfaces in many cases. Although those who had grade IV changes did not fare very well, there was an overall improvement in pain and function and activity. The two patients with the highest postoperative Lysholm scores (96 & 99 respectively) had had no joint surface damage preoperatively and no pain postoperatively (0 on the Borg scale). However, return to pre-injury level of activity is by no means the rule. Only one patient was able to return to the same level of sporting activity. In general, however, all but one patient reported some degree of improvement.
Conclusion: It is difficult to draw firm conclusions from this small cohort with short-term follow-up. However, it appears that although it is possible to achieve some improvement in patients with severe articular surface damage, the results are far better if the patient is referred early enough prior to the onset of severe degenerative joint disease. This begs the question whether this procedure should perhaps be recommended for patients who have had meniscectomies and have little or no symptoms.

Meniscal Lesion Repair After Implantation Of New Porous Polymers. A Study In Dogs

Authors: T.G. van Tienen, P. Buma, R.G.J.C. Heijkants*, N.G. Lieuwes,
J.H. de Groot*, R.P.H. Veth
Orthopaedic Research Laboratory, University Medical Centre, Nijmegen,
The Netherlands
*Polymer Chemistry, University of Groningen, The Netherlands

Purpose of the study. Bucket-handle lesions in the avascular part of the meniscus do not heal spontaneously. Connecting the lesion to the meniscus' vascular periphery by implanting a smart scaffold in a partial thickness defect may induce healing.
Materials and methods. We created partial thickness defects in 22 menisci of 16 Beagle dogs with lesions which had full thickness longitudinal extensions in the avascular meniscus substance. In 12 lateral menisci a newly developed porous degradable copolymer implant of 50/50 L-lactide/e-caprolactone was sutured into the defect. 10 meniscal defects were left empty and served as controls. Healing of the lesion, repair of the defect and consequences for the tibial cartilage were evaluated macroscopically, routine histologically and immunohistochemically.
Results. Six months after surgery all polymers were completely incorporated and resembled normal meniscal fibrocartilage, which was confirmed by matrix staining. Ten cases in the implant group showed at least partial healing of the lesion compared to four in the control group. Also the ingrown tissue in the implants more frequently showed a fibrocartilaginous aspect than in controls. Cartilage degeneration with ulcera occurred three times in the implant group while in controls all cases had this aspect. In all implant cases only few macrophages and giant cells were seen.
Conclusions. In meniscal defects with a porous polymer, more healing of the longitudinal full thickness lesions occurred and more fibrocartilage was detected in the implants. A degrading porous polymer seems an adequate scaffold to enable repair tissue to reach the lesion and restores the fibrocartilage in the defect rapidly. This method might be adequate to repair lesions in the avascular zone of the meniscus.

Porcine Xenografts for Orthopaedic Applications

Authors: *+Stone KR, *Walgenbach AW, +Turek TJ, **+Galili U
*The Stone Clinic, 3727 Buchanan St., San Francisco, CA
**Rush University, Chicago, IL
+CrossCart Inc., SanFrancisco, CA

More than 350,000 cruciate ligaments are reconstructed in the U.S each year, 70% of which use the patient's own patellar tendon. The autogenous harvest is associated with anterior knee pain, weakness, scar formation, and patella tendon complications. Substitute tissues include the hamstrings and allografts with varying degrees of success and complications.
Efforts to replace the cruciate ligament with synthetic materials have failed and are no longer in use in the U.S. Early efforts to replace the cruciate ligament with bovine xenograft tissue were successful for some of the patients who received the tissue. Other bovine graft patients suffered complications from synovitis, graft loosening, failure of fixation, and abrasion. Much of the synovitis was attributed to the high levels of glutaraldehyde in which the product was packaged.
It is our belief that the ideal tissue replacement would be a de-antigenated porcine patellar tendon due to similar biological, anatomical and biomechanical properties to human tissue. We have identified the key antigens that cause rejection and have developed a processing technique of de-antigenation within the imposed constraints that the end product exhibit similar biomechanical characteristics as native tissue.
This talk will present the results of our work identifying the antigens in a porcine bone-patellar tendon-bone device, describing the enzymatic removal technique, testing the implants in animal immunologic models, and comparing the resulting initial biomechanical properties of the device to human allografts. Additional work will be presented reviewing development of porcine graft tissues in the areas of bone, meniscal and articular cartilage grafts.

The Future of Meniscal Transplantation in Europe

Authors: Henrik Aagaard, Denmark
European Meniscal Transplantation Group (EMTG)

During the past two decades experimental and clinical studies dealing with meniscal replacement have been reported from various parts of Europe, and most of them are rather recent. Studies dealing with both meniscal transplantation and other types of meniscal replacement have been reported. Meniscal replacement in Europe is currently rather sporadic and only very few clinics offer it as a routine treatment. Until recently meniscal replacement was not coordinated and formalized meeting activity were non-existent.
The health care systems in Europe vary from country to country, and there are large cultural differences from north to south and from east to west, but there seems to be an increasing European interest in the subject of meniscal replacement.
Based on an increasing need to meet and share experiences, the European Meniscal Transplantation Group (EMTG) was founded in London September 2000. The EMTG is informally affiliated to the European Society of Sports Traumatology, Knee Surgery, and Arthroscopy (ESSKA), and the group plans to meet every second year during the ESSKA Congress.
The EMTG intends to establish and maintain contact with the Meniscal Transplantation Study Group in USA, and hope to benefit from their greater experience dealing in meniscal replacement. Hopefully the contact will become one of mutual benefit within the coming years. The EMTG intends to contact persons and clinics in Asia who have reported on meniscal replacement.
Those subjects that the EMTG would like to emphasize in the years to come are standards for patient evaluation, tissue banks (centralization, industry vs. healthcare system, preservation techniques, rehabilitation protocols, common clinical databases, surgical techniques, experimental animal models, coordination of future studies, development of new ideas.

The aim of the EMTG is to influence the future of meniscal transplantation, rather than to control it.

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