van Aaken J, Holzer N, Wehrli L, Delaquaize F, Gonzalez I A, Beaulieu J Y
1 Service de chirurgie orthopédique et traumatologie de l'appareil moteur, Hôpital Universitaire de Genève, Genève, Switzerland.
2 Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
J Hand Surg Eur Vol. 2016 Nov;41(9):917-922. doi: 10.1177/1753193416651573. Epub 2016 Sep 28.
The PI2® spacer is designed for treatment of trapeziometacarpal (TM) osteoarthritis. However, the shape of this implant has raised concerns about its stability. We retrospectively investigated 45 implants in 41 patients treated for trapeziometacarpal osteoarthritis in our hospital between 2004 and 2009 who underwent trapeziectomy and insertion of a PI2® spacer. Outcome parameters included revision rates and clinical outcomes correlated with implant position and scaphometacarpal distance, assessed using standard radiographs. A total of 12 implants (27%) were removed at a median time of 10 months (interquartile range (IQR), 7-22 months). These included five dislocations and one early infection. Additionally, a further six patients underwent revision due to persistent pain. Three of these had scapho-trapezoid osteoarthritis, two had developed subluxation of the implant, and one did not show any radiographic abnormalities. A review of patient records revealed that 33 implants remained in place at a median time of 29 months (IQR, 20-57). However, of those, only 21 implants (64%) in 17 patients were available for clinical evaluation at a median follow-up of 29 months (IQR, 19-62 months). No significant differences in clinical outcomes including functional results were observed between in-place ( n = 8) and subluxated ( n = 13) implants. Due to the high revision rate (12/45), consistent with other reports in the literature, we have abandoned the use of the PI2® spacer. We recommend the establishment of a registry for evaluation of future implants.
TYPE OF STUDY/LEVEL OF EVIDENCE: Case-series study/level IV.
PI2®间隔器设计用于治疗第一掌腕关节（TM）骨关节炎。然而，这种植入物的形状引发了对其稳定性的担忧。我们回顾性研究了2004年至2009年期间在我院接受第一掌腕关节骨关节炎治疗的41例患者中的45枚植入物，这些患者接受了大多角骨切除术并植入了PI2®间隔器。结果参数包括翻修率以及与植入物位置和舟掌距离相关的临床结果，通过标准X线片进行评估。共有12枚植入物（27%）在中位时间10个月（四分位间距（IQR），7 - 22个月）被取出。其中包括5例脱位和1例早期感染。此外，另有6例患者因持续疼痛接受了翻修手术。其中3例患有舟大多角骨关节炎，2例植入物发生半脱位，1例未显示任何影像学异常。对患者记录的审查显示，33枚植入物在中位时间29个月（IQR，20 - 57）时仍在位。然而，在这些患者中，仅17例患者的21枚植入物（64%）可在中位随访29个月（IQR，19 - 62个月）时进行临床评估。在位（n = 8）和半脱位（n = 13）的植入物之间在包括功能结果在内的临床结果方面未观察到显著差异。由于翻修率高（12/45），与文献中的其他报道一致，我们已不再使用PI2®间隔器。我们建议建立一个登记处来评估未来的植入物。
研究类型/证据水平：病例系列研究/IV级。
