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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 328 - 328
1 Sep 2012
Zaffagnini S Marcacci M Marcheggiani Muccioli GM Bulgheroni P Berbig R Holsten D Lagae K Monllau J Crespo R Bulgheroni E
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INTRODUCTION

The purpose of this study is to report results from a prospective multicenter study of a bioresorbable type I collagen scaffold used to replace tissue loss following irreparable lateral meniscus injuries.

METHODS

49 non-consecutive patients (33M/16F; mean age 30.5 yrs, range 14.7–54.7 yrs) with irreparable lateral meniscus tears or loss requiring surgical treatment were prospectively enrolled at one of 7 EU centers. 11 patients (22%) had acute injuries of the lateral meniscus, while 38 (78%) had prior surgeries to the involved meniscus. Implantation of the LCMI (now Lateral Menaflex) was performed arthroscopically using an all-inside suturing technique (FASTFIX) combined with inside-out sutures in the more anterior meniscus aspect. Forty-three patients were evaluated with a 2 to 4-year follow-up (FU); mean FU duration was 45 months (range, 33–53 m). Patients were evaluated clinically and by self-assessment using Tegner activity and Lysholm function scores, as well as the Visual Analog Scales (VAS) for pain, and a satisfaction questionnaire. Evaluations were performed pre-operatively, 6 months, 1 year, 2 and 4 years after surgery. X-ray and/or MR-images were taken pre-operatively, and at 1 year and 2 years after surgery.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 509 - 509
1 Oct 2010
Zaffagnini S Berbig R Bulgheroni P Crespo R Holsten D Koen CL Marcacci M Juan CM
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Introduction: The Collagen Meniscus Implant (CMI) has been shown to be effective for the replacement of lost medial meniscus tissue; however, no such device has been available for treatment of similar injuries to the lateral meniscus. Loss of the lateral meniscus results in a rapidly increased rate of knee degeneration compared to similar medial injuries. The purpose of this study was to determine if a CMI developed for use in treatment of lateral meniscus deficiencies is as safe and effective as has been reported for the medial CMI.

Methods: Prospectively, 60 patients (12–65 years of age) were enrolled at 7 sites between March 2006 and October 2007. Patients had irreparable lateral meniscus tears requiring partial meniscectomy. The knee had to be ligamentously stable and in neutral alignment and with no untreated Grade IV cartilage damage. Patients gave informed consent and agreed to comply with postoperative assessments and standardized rehabilitation. The surgical technique involved insertion of the dry implant into the lateral compartment of the knee joint. Fixation of the implant to the host meniscus rim was accomplished with either an all-inside suture technique or a hybrid all-inside/inside-out technique. Clinical evaluations and patient self-assessments were conducted preoperatively and at defined intervals through 2 years postoperatively. Procedure specific intraoperative parameters, radiographic evaluations, and adverse events were documented. Data collection was monitored by a third party according to GCP regulations.

Results: 49 patients received a lateral CMI. Currently, 24 patients have 1-year follow-up and 13 patients have been followed approximately 2 years; the mean follow-up is 22 months. Follow-up included assessments of changes in Lysholm, pain, Tegner and patient satisfaction. All patients showed clinical improvement from the preoperative to the 1 year postoperative time points. Four patients experienced adverse events which required an additional arthroscopic procedure between 4 and 16 months and included removal of implant remnants, synovectomy and debridement.

Conclusions: These preliminary results appear to suggest that implantation of lateral CMI leads to improved clinical outcomes in pain, function, self-assessment and activity levels. Frequency and type of adverse events are comparable to those for suture repair reported in the literature. Based on results reported for the medical CMI, we anticipate that these lateral CMI patients will have improved long-term results compared to partial lateral meniscectomy.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_III | Pages 427 - 427
1 Oct 2006
Bulgheroni P Bulgheroni M Ronga M Manelli A
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Aim of this study is the investigation of lower limbs biomechanics before and after meniscectomy.

Materials and methods: Ten volunteers candidate to partial medial meniscectomy underwent motion analysis before surgery, six months and one year after. Ten healthy volunteers acted as a control group

Data were acquired by means of Vicon motion analysis system

Results: In gait patterns investigation, joint kinematics does not show significant modifications before and 6 months after surgery, 12 months after surgery hip and knee show a greater flexion.

The dynamic analysis stresses alterations in knee sagittal moment. Before surgery the knee flexion moment is reduced. After partial meniscectomy the knee flexion moment increases in both the limbs. In squatting investigation, main focus was on repeatability. Before surgery high inter subjects variability affects knee joint angle; while after surgery high variability affects also hip and ankle.

Conclusions: After meniscectomy, gait and squatting patterns are still altered. Before surgery, the joint mechanical structure is not highly altered and modifications are mainly due to pain avoidance schemas; after partial meniscectomy, pain disappears and the new joint behaviours are probably caused by the new mechanical asset and/or proprioceptive mechanisms.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_II | Pages 198 - 198
1 Apr 2005
Ronga M Bulgheroni P Grassi F Cherubino P
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Matrix-induced autologous chondrocyte implantation (MACI) is a tissue engineering technique which requires the use of a collagen membrane on which the cultured chondrocytes are seeded. We report on the arthroscopic MACI technique for the treatment of chondral defects in the lateral tibial plate of the knee.

The implantation procedure was performed on two male patients affected by traumatic chondral lesions, 2.5 and 2 cm2 in size, respectively. The procedures were performed through traditional artrhoscopic portals and the seeded membrane was fixed with fibrin glue. Clinical-functional evaluation was performed according to ICRS score, modified Cincinnati knee score, IKDC, Lysholm II and Tegner scales. MRIs were taken 6, 12 and 24 months postoperatively.

After 2 years all the clinical scores were improved in both patients. MRI showed filling of the defects with hyaline-like tissue with reduction of subchondral bone oedema and restoration of a regular articular surface.

Even though the MACI technique is mostly performed with an open procedure, the site of these lesions could not be reached without sacrifying tendinous and ligamentous structures of the knee. With the arthroscopic approach an optimal view of the lesion could be achieved and appeared to be the best solution for these patients. The size of these defects was too large for bone marrow stimulation techniques and/or osteochondral grafts to be successful. By using fibrin glue for fixating the seeded membrane the procedure could be performed arthroscopically in a simple and safe way. No specifically designed instruments were used in these cases.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_II | Pages 198 - 198
1 Apr 2005
Bulgheroni P Ronga M Grassi F Genovese E Cherubino P
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We report the clinical results and MRI findings observed in 50 patients who underwent collagen meniscus implant (CMI) between March 2001 and October 2003. Fifty patients affected by irreparable meniscal lesions or who had previously undergone partial medial meniscectomy were arthroscopically treated with CMI, a tissue engineering technique designed to promote meniscal regeneration. Average age at the time of surgery was 38.4 years. The average size of the lesion/defect was 4.3 cm. Additional procedures included 16 ACL reconstructions, eight high tibial osteotomies and two autologous chondrocyte implantations. All knees were evaluated according to the Lysholm II and Tegner activity scales. MRI was performed 6, 12 and 24 months postoperatively. Six arthroscopic examinations of the implant were performed at different times (6 to 16 months postoperatively).

Postoperative complications included saphenus neuroapraxia in three patients and CMI rupture in one patient who presented with persistent knee swelling. Follow-up averaged 16.5 months, with a minimum of 6 months. At the most recent evaluation, 46 patients showed an improvement in the clinical scores. A progressive, uniform signal was evident by MRI. At the second arthroscopic study, free fragments of the implant were observed in cases of CMI rupture. In another patient, partial resorption of CMI was observed at the posterior horn. The remaining four arthroscopic examinations demonstrated regeneration of meniscal-like tissue.

Clinical results achieved with CMI are promising. MRI proved to be an effective tool for monitoring the evolution of the implant and showed good correlation with clinical outcomes and arthroscopic findings at follow-up.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_II | Pages 197 - 198
1 Apr 2005
Cherubino P Ronga M Grassi F Protasoni M Genovese E Bulgheroni P
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We prospectively evaluate clinical results and MRI findings on a series of 47 patients, with an average age of 31.7 years, treated by matrix-induced autologous chondrocyte implantation (MACI) for knee and ankle chondral defects.

As isolated lesions, the joints affected were 37 knees and five ankles. As combined lesions, there were four knees and one kissing lesion in the ankle. The average size of the defects was 3.5 cm2. Clinical-functional evaluation was carried out according to ICRS, modified Cincinnati knee, Lysholm II and Tegner scales. The AOFAS score was used for the evaluation of the ankle. MRIs were taken before the operation as well as at 6, 12 and 24 months postoperatively. Among 10 second arthroscopic studies (four knees, six ankles), two biopsies were carried out after 2 years, from the medial femoral condyle and the patella, respectively. These specimens were evaluated by light microscopy, immunohistochemistry (type I and II collagen), SEM and TEM analysis.

Follow-up averaged 25.6 months. At the latest follow-up, knee scores improved after surgery. AOFAS did not improve in the patient with the kissing lesion. MRIs showed hyaline-like cartilage at the site of implantation in all treated joints with exception of the kissing lesion; four knees showed recurrence of subchondral bone oedema 1 year after surgery. Histological analysis on the biopsies revealed good definition of the tidemark and presence of type II collagen.

Clinical results and MRI findings support the efficacy of the MACI technique. Morphological findings are indicative for hyaline-like tissue formation in the implant site.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 344 - 344
1 Mar 2004
Bulgheroni P Ronga M Reguzzoni M Passi A Grassi F Cherubino P
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Aims: Collagen meniscus implant (CMI) is a tissue engineering technique for the management of irreparable meniscal lesions. We report early clinical results achieved on 30 patients. The implant was also investigated by ultrastructural and biochemical analysis. Methods: Thirty patients, affected by irreparable meniscal lesions, were arthroscopically treated. Average age at the time of surgery was 38.6 years. Additional procedures included 8 ACL reconstruction, 2 high tibial osteotomy and 1 autologous chondrocyte implantation. All knees were evaluated according to the Lysholm II and Tegner activity scales. MRI was performed 6 and 12 months postoperatively. A biopsy of the implant was performed in occasion of a second arthroscopic look in two patients 6 months after surgery. The specimens, as well as the scaffold before implantation, were studied by light microscopy, TEM, SEM, EDAX microanalysis, HPLC and FACE analysis. Results: Follow up averaged 9.3 months. At 3 months, 27 patients showed an increase in the clinical scores. A progressive uniform signal was evident by MRI. Morphological analysis of the speciments showed hyaline tissue inþltrated by cells and vessels, surrounded by the scaffold þbers. At EDAX microanalysis no calciþcations were detected inside the speciments. Biochemical assays demonstrated the presence of GAG molecules of hyaluronic acid and chondroitinsulphate, that were not present in the scaffold before implantation. Conclusions: Early CMI results are promising and are supported by morphological and biochemical þndings, that indicate enhancement of new meniscal tissue by the scaffold.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 314 - 314
1 Mar 2004
Ronga M Grassi F Bulgheroni P Cherubino P
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Methods: The implantation procedure was performed on two male patients affected by traumatic chondral lesions, sized respectly 2.5 and 2 cm2. The operations were performed through traditional artrhoscopic portals and the seeded membrane was þxed with þbrin glue. Clinical-functional evaluation was performed acc. Aims: Matrix-induced autologous chondrocyte implantation (MACÏ) is a tissue engineering technique which requires the use of a collagen membrane on which the cultured chondrocytes are seeded. We report the arthroscopic MACÏ technique for the treatment of chondral defects interesting the lateral tibial ording to ICRS score, modiþed Cincinnati knee score, IKDC, Lysholm II and Tegner scales. MRIs were taken 6 and 12 months postoperatively. Results: After one year all the clinical scores were improved in both patients. MRI showed þlling of the defects with hyaline-like tissue with reduction of subchondral bone edema. Conclusions: Even though the MACÏ technique is mostly performed with an open procedure, the site of these lesions could not be reached without sacrifying tendinous and ligamentous structures of the knee. The arthroscopic approach allowed to achieve an optimal view of the lesion and appeared the best solution for these patients. The size of these defects was too large for bone marrow stimulation techniques and/or osteochondral grafts to be successful. The development of dedicated instruments for arthroscopic MACÏ will allow to improve and simplify the surgical procedure.