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Polyurethane scaffold promotes meniscal regeneration, shows good 2-year results

GENEVA —  Arthroscopic implantation of a polyurethane scaffold to treat partial meniscal lesions showed good results over other meniscal treatment methods at the 2-year follow-up, according to research presented at the European Society of Sports Traumatology Knee Surgery and Arthroscopy Congress 2012, here.

Researchers from Istituto Ortopedico Rizzoli conducted the prospective clinical study using the Actifit scaffold (Orteq Ltd., London), which they started implanting 3 years ago, according to Giulio M. Marcheggiani Muccioli, MD, who presented the results.

“This new scaffold is very interesting with preliminary results comparable to the CMI (Menaflex Collagen Meniscus Implant; Regen Biologics), but with an easier surgical management,” Muccioli said in his presentation.

The team has experience with other meniscal scaffolds, including the CMI product, which is collagen-based, but ran into technical problems with handling, intraoperative breakage and absorption at long-term follow-up. Therefore, they sought another solution for partial meniscal tears, Muccioli said.

According to the abstract, he and colleagues evaluated patients clinically and with MRI for the study and saw International Knee Documentation Committee (IKDC) subjective knee scores improve with the new scaffold from 47.3 ± 17.5 to 72.9 ± 13.9 through the 1-year follow-up period. The IKDC scores increased to 74.6 ± 15.3 at 2 years after implantation, according to the abstract. The researchers also observed a greater IKDC score improvement, to 77.7 ± 15.7, among patients who did not undergo concomitant cartilage treatments or osteotomies.

The team treated 25 patients with massive loss of either medial or lateral meniscal substance with the polyurethane scaffold; 18 patients (11 men, 7 women; mean age 45 years) reached the study’s 2-year minimum follow-up, Muccioli said. In all cases, the loss of meniscal structure was associated with intra-articular or global knee pain and/or swelling. Researchers continued to evaluate patients clinically and through MRI scans for 2 years after surgery, according to the abstract.

Investigators excluded 1 patient from the analysis due to a re-injury suffered playing competitive soccer after the 12-month follow-up. Two second-look arthroscopies performed at 6 months postoperatively showed the scaffolds were in place with no signs of resorption, Muccioli said.

“Now long-term results are needed to solve these three questions regarding the resorption, cartilage protection and synovitis,” he said.

Reference:

  • Muccioli GMM, Zaffagnini S, Kon E, et al. Meniscal regeneration by a new polyurethane scaffold. A 2-year minimum follow-up study. Paper #FP12-666. Presented at the European Society of Sports Traumatology Knee Surgery and Arthroscopy Congress 2012. May 2-5. Geneva.
  • Disclosure: Muccioli receives other financial or material support from Regen Biologics and Igea Medical.

GENEVA —  Arthroscopic implantation of a polyurethane scaffold to treat partial meniscal lesions showed good results over other meniscal treatment methods at the 2-year follow-up, according to research presented at the European Society of Sports Traumatology Knee Surgery and Arthroscopy Congress 2012, here.

Researchers from Istituto Ortopedico Rizzoli conducted the prospective clinical study using the Actifit scaffold (Orteq Ltd., London), which they started implanting 3 years ago, according to Giulio M. Marcheggiani Muccioli, MD, who presented the results.

“This new scaffold is very interesting with preliminary results comparable to the CMI (Menaflex Collagen Meniscus Implant; Regen Biologics), but with an easier surgical management,” Muccioli said in his presentation.

The team has experience with other meniscal scaffolds, including the CMI product, which is collagen-based, but ran into technical problems with handling, intraoperative breakage and absorption at long-term follow-up. Therefore, they sought another solution for partial meniscal tears, Muccioli said.

According to the abstract, he and colleagues evaluated patients clinically and with MRI for the study and saw International Knee Documentation Committee (IKDC) subjective knee scores improve with the new scaffold from 47.3 ± 17.5 to 72.9 ± 13.9 through the 1-year follow-up period. The IKDC scores increased to 74.6 ± 15.3 at 2 years after implantation, according to the abstract. The researchers also observed a greater IKDC score improvement, to 77.7 ± 15.7, among patients who did not undergo concomitant cartilage treatments or osteotomies.

The team treated 25 patients with massive loss of either medial or lateral meniscal substance with the polyurethane scaffold; 18 patients (11 men, 7 women; mean age 45 years) reached the study’s 2-year minimum follow-up, Muccioli said. In all cases, the loss of meniscal structure was associated with intra-articular or global knee pain and/or swelling. Researchers continued to evaluate patients clinically and through MRI scans for 2 years after surgery, according to the abstract.

Investigators excluded 1 patient from the analysis due to a re-injury suffered playing competitive soccer after the 12-month follow-up. Two second-look arthroscopies performed at 6 months postoperatively showed the scaffolds were in place with no signs of resorption, Muccioli said.

“Now long-term results are needed to solve these three questions regarding the resorption, cartilage protection and synovitis,” he said.

Reference:

  • Muccioli GMM, Zaffagnini S, Kon E, et al. Meniscal regeneration by a new polyurethane scaffold. A 2-year minimum follow-up study. Paper #FP12-666. Presented at the European Society of Sports Traumatology Knee Surgery and Arthroscopy Congress 2012. May 2-5. Geneva.
  • Disclosure: Muccioli receives other financial or material support from Regen Biologics and Igea Medical.

    Perspective

    Irreparable major meniscal tears pose a very difficult problem in the young and active patients who sustain these kinds of injuries. The goal is to restore the load-bearing function of the meniscus, decrease symptoms and provide chondroprotective effects. Most meniscal transplants gradually deteriorate, tear or shrink, thereby losing the ability to provide function. The scaffold used in this study is biocompatible and laboratory studies indicate the scaffold may still be present 5 years after implantation, increasing time to form a new natural regenerated meniscus.

    The application of stem cells or growth factors to the implanted device could increase the biologic response and remodeling process of this scaffold. The final goal still remains finding a combination of matrix scaffold, cell type, bioreactor design and environmental conditions to obtain the best clinical results at long-term follow-up. The results from this study are promising, but longer follow-up is needed to determine long-term clinical outcome and to evaluate the chondroprotective effect of this technique.

    • Geert Meermans, MD
    • Lievensberg Hospital Berchem, Belgium

    Disclosures: Meermans has no relevant financial disclosures.

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