CMI – Facts and Figures

The first CMI procedures were performed as early as 1993 as part of a feasibility study. Additional multi-center studies followed, and in the year 2000 CE certification for the medial implant followed. The lateral CMI was developed somewhat later and was approved in 2006 in Europe and placed into clinical use.

Clinical Experience with CMI & Treatment Success

Clinical studies and patient experience have confirmed the safety and effectiveness of the Collagen Meniscus Implant. There are several key findings important for patients to know:¹ 

  • On average, patients with either chronic or acute meniscus injuries who receive the CMI scaffold have more tissue within the meniscus following surgery than patients having only a partial meniscectomy.
  • CMI patients with chronic meniscus injuries regain more lost activity than patients not receiving the CMI scaffold.
  • Patients with chronic meniscus injuries who have a CMI implant are more satisfied than patients with a mere partial meniscectomy. CMI patients with chronic meniscus injuries are three times less likely to need another meniscus surgery.

In a 313 patient randomized, controlled, multicentre clinical trial conducted by the company at 16 sites, involving 26 surgeons throughout the United States, over 90% of the CMI patients showed new tissue growth following the use of the CMI implant. On average, the CMI patients in this study regained over 70% of their original meniscal tissue area.¹ 

CMI long-term study results

Two studies with a minimum observation period of 10 years attest to CMI long-term success:² ³  

  • The results of the 10-year study by Monllau et. al. which appeared in 2011 in the specialist journal "Arthroscopy" can be summarized in the following statement:
    “The CMI provided significant pain relief and functional improvement for a time period of over 10 years.
    Although the implant generally diminished in size, the procedure proved to be safe with a low failure rate on a long-term basis. No development or progression of degenerative knee joint changes were observed in most cases.”
  • In a study by Zaffagnini et. al the results after CMI treatment are compared with the results from patients with partial medial meniscectomy alone. With a minimum 10 year follow-up, 87% of patients benefited from implantation of the medial CMI implant with improvements in pain, activity levels and radiological outcomes superior to partial meniscectomy.

 

 

  1. Rodkey WG, DeHaven KE, Montgomery WH 3rd, Baker CL Jr, Beck CL Jr, Hormel SE, Steadman JR, Cole BJ,
    Briggs KK. Comparison of the collagen meniscus implant with partial meniscectomy. A prospective randomized
    trial. J Bone Joint Surg Am. 2008 Jul; 90(7):1413-26.
  2. Monllau JC, Gelber PE, Abat F, Pelfort X, Abad R, Hinarejos P, Tey M. Outcome After Partial Medial Meniscus
    Substitution With the Collagen Meniscal Implant at a Minimum of 10 Years‘ Follow-Up.
    Arthroscopy. 2011 Jul; 27(7):933-43. Epub 2011 May 31.
  3. Zaffagnini S, Marcheggiani Muccioli GM, Lopomo N, Bruni D, Giordano G, Ravazzolo G, Molinari M, Marcacci M. Prospective Long-Term Outcomes of the Medial Collagen Meniscus Implant Versus Partial Medial Meniscectomy: A Minimum 10-Year Follow-Up Study. Am J Sports Med. 2011 Mai; 39(5):977-85. Epub 2011 Feb 4.