Kontrollierte prospektive randomisierte Studie zum Vergleich eines individuellen nicht verankerten Kniegelenk-Implantats (iForma) mit der Tibiakopf-Umstellungsosteotomie zur Behandlung unikompartimenteller Gonarthrosen
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Beschreibung
Between September 2004 and October 2007, 22 patients were recruited for a controlled clinical study at the Department for Orthopedics and Orthopedic Surgery at the University Hospital of Giessen. 13 of the patients were randomly assigned to the test group, nine to the control group. The aim of the study was to compare the clinical outcomes of treatment of unicompartmental gonarthrosis with a knee-implant (iForma) and the experiences of the open-wedge-osteomy (HTO). After three, six, twelve and 24 months, the Knee-Society-Score (KSS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Visual-Analogue-Scale for pain (VAS) as well as questions regarding subjective patient assessment were documented and statistically analyzed. Further, possibly insufficient extension and the duration of the operative procedure were reported. Since the study was finished prematurely in coordination with the ethics committee due to adverse events in the iForma group, the number of subjects was limited.
The postoperative mean KSS improved its value from 108 (HTO), respectively 111 (iForma) to 166, respectively 163 after 24 months. The WOMAC in the iForma-group had an improvement of the mean value from 51 to 20.1 and in the HTO-group from 43.6 to 16.4. The VAS for pain improved during the period of observation in both groups significantly, and peaked in the HTO-group with an improvement of the mean value from 22.2 to 9.67 and in the iForma-group from 24.9 to 8.62. Regarding subjective patient contentment, no significant differences between the two groups were found. Insufficient extension was significantly more prevalent in the test group than in the control group. The average duration of procedure was significantly longer in the control group (95.8 min) than in the test group (46.1 min).
Indeed, statistical calculations do not show significant differences between the two groups. However, that does not consider failures. The iForma-implants has been removed in four of 13 cases, which is equivalent to a loss ratio of 31 %. In view of these numbers, it is not expected that custom built implants are a safe option for a joint-conservative treatment of unilateral gonarthrosis.
Autor*in
Jarno Schulz-Simonsen