2015 ISAKOS Biennial Congress ePoster #1634
A Novel Polycarbonate-Urethane Meniscus Implant for the Treatment of Middle-Aged Patients: Results of 27 Patients in Italy
Vincenzo Condello, MD, Negrar, Verona ITALY
Daniele Screpis, Resident, Verona, Verona ITALY
Mariasole Bigon, Researcher, Padova, Padova ITALY
Emanuele Nocco, MSc, Voltorre di Gavirate ITALY
Jonathan Jacob Elsner, PhD, Cambridge, MA UNITED STATES
Nogah Shabshin, MD, Tel Aviv ISRAEL
Eran Linder-Ganz, PhD, Netanya ISRAEL
Claudio Zorzi, MD, Verona, Veneto ITALY
Sacro Cuore Hospital, Negrar , Verona, ITALY
FDA Status Not Applicable
Summary: Use of polycarbonate-urethane meniscus implant in patients with medial pain due to previous medial meniscectomy or to degenerative medial meniscus insufficiency, too old for a biological treatment and too young for joint replacement: the italian experience on 27 patients.
Abstract:
The purpose of this study was to evaluate patient reported outcomes and post-operative MRI findings following the implantation of a polycarbonate-urethane meniscus implant for the treatment of medial meniscal insufficiency in middle-aged patients.
The meniscus implant was designed to be inserted into the medial compartment of the knee by a mini-arthrotomy, and lie between the tibia and femur without requiring attachment or bone resection. In-vitro studies have shown that the implant can restore the pressure distribution function of the meniscus and thus it was hypothesized that by doing so, it may relieve pain. In the younger population, (<40 yrs.) surgical options e.g., partial meniscectomy, allograft transplants and artificial scaffolds are available and have been shown to be effective. For middle-aged patients, however, the clinical benefit from surgical intervention of a degenerated meniscus has only been reported in a fraction of the patients and they are still too young for more aggressive treatments such as unicompartmental or total knee arthroplasty.
Twenty-seven patients aged 43 to 71 years were treated with the implant after signing an informed consent and meeting the criteria defined in the Ethics Committee approved protocol. All of the patients reported medial knee pain, which was associated with either a severely degenerated meniscus (44%) or post-meniscectomy knee pain (56%). Patients with evidence of grade IV (Outerbridge) medial articular cartilage loss or instability were excluded from the study. The primary clinical outcome was measured by the KOOS scale over 24 months, with secondary outcomes measured by IKDC subjective and VAS questionnaires for pain. Serial MRI scans were taken at 1.5, 12, and 24 months to evaluate the condition of the joint.
Study subjects reported a very good improvement 24 months post implantation, as reflected by a 53% increase of the KOOS Overall score (p<0.05). Specifically, KOOS Pain and Pain VAS scores were improved by 53% and 70%, respectively (p<0.05). Similarly, Activity, Sport, and Quality-of-Life KOOS scores increased by 41%, 130%, and 91%, respectively (p<0.05). The symptoms subscale showed a non-significant increase of 20%. The MR-findings were also encouraging, with no signs of deterioration of the cartilage in the majority of patients. Main complications so far includes four cases of device damage, one case of dislocation due to insufficient removal of the posterior meniscal horn, one operation-room infection, and one patient who requested to remove the device due to persistent pain.
This study was designed to evaluate and obtain assurance of the safety and efficacy ratio of a novel medial meniscus implant in the treatment of a challenging patient cohort. Short- term outcomes are promising and long-term results are ongoing.