Orthopedics Surgery and Traumatology Department, Dr Peset University Hospital, avenue Gaspar Aguilar 90, 47017 Valencia, Spain.
Department of Orthopaedic Surgery, Helios ENDO-Klinik Hamburg, Holstenstrasse 2, 22767 Hamburg, Germany.
Orthop Traumatol Surg Res. 2018 Dec;104(8):1171-1178. doi: 10.1016/j.otsr.2018.06.016. Epub 2018 Oct 31.
Modular hip arthroplasty is widely recognized in hip surgery; nevertheless, despite advances in prosthetic design, the incidence of hip revision surgery is increasing. In these procedures, a modular adapter that engages the femoral stem and the modular femoral head could be useful in order to protect the neck-head junction and restore preoperative biomechanics and soft tissue tension when the femoral or acetabular component should be retained. The Merete™ BioBall™ system (Merete Medical, Berlin, Germany) could fill this need. However the literature regarding this device is sparse, therefore we performed a systematic review to analyze: the indications for its use and clinical results and the causes of second revision and survival in hip revision surgery, mainly focus in complications of its use.
Databases including PubMed and Google Scholar were searched for English-language articles published between 01/01/1999 and 01/04/2017, using search terms related to the system Merete™ BioBall™. Studies that reported the clinical use of the Merete™ BioBall™ system in hip revision surgery were selected. Data related to the indications, characteristics of the implant, clinical results, causes of second revision and survival were gathered.
A total of 14 studies with a level IV evidence were analyzed. Information related to the implant was provided in 194 cases. Isolated acetabular revision was the main indication of implant use (139/194 [71.6%]). The most common combination used was the standard implant (69/110 specified [59.4%]), 3XL length (28/107 specified [26.2%]) with 32mm metal head (58/187 specified [31%]). After a follow-up ranging from 2 to 97 months, there were 16 complications, thirteen (81,2%) were revised, including one neck fracture of the stem (6.25%), two ceramic head fractures (12,5%) and six recurrent dislocations (37,5%). Implant survival was 92.8% at 52.5 months of follow-up in the longest published series. Clinical and functional results were provided in a heterogeneous way.
There is insufficient evidence to recommend for or contraindicate the use of the Merete™ BioBall™ system. The Isolated acetabular revision was the main indication of implant use. When dislocation is the indication of its use the rate of second revision is high. Some important complications possibly related with the implant design have been reported but as isolated cases. The neck adapter failure or corrosion phenomena have not been reported. Further prospective and controlled trials are needed to assess the use of this type of implant and its survival.
Level III systematic review of case series.
模块化髋关节置换术在髋关节手术中得到广泛认可;然而,尽管假体设计有所进步,髋关节翻修手术的发生率仍在增加。在这些手术中,一种与股骨柄和模块化股骨头配合使用的模块化适配器可以用于保护颈干交界区,并在需要保留股骨或髋臼部件时恢复术前的生物力学和软组织张力。Merete™ BioBall™ 系统(Merete Medical,柏林,德国)可以满足这一需求。然而,关于该设备的文献很少,因此我们进行了系统评价,以分析:使用的适应证和临床结果,髋关节翻修手术中二次翻修和生存率的原因,主要关注其使用的并发症。
检索了包括 PubMed 和 Google Scholar 在内的数据库,以获取 1999 年 1 月 1 日至 2017 年 1 月 4 日期间发表的英文文章,使用与 Merete™ BioBall™ 系统相关的检索词。选择了报告 Merete™ BioBall™ 系统在髋关节翻修手术中临床应用的研究。收集了与适应证、植入物特征、临床结果、二次翻修原因和生存率相关的数据。
共分析了 14 项 IV 级证据研究。194 例提供了与植入物相关的信息。单纯髋臼翻修是植入物使用的主要适应证(139/194[71.6%])。最常用的组合是标准植入物(110 个指定中 69 个[59.4%]),3XL 长度(107 个指定中 28 个[26.2%])和 32mm 金属头(187 个指定中 58 个[31%])。随访 2 至 97 个月后,共发生 16 例并发症,其中 13 例(81.2%)需要翻修,包括 1 例(6.25%)股骨柄颈骨折、2 例(12.5%)陶瓷头骨折和 6 例(37.5%)复发性脱位。在最长的已发表系列中,52.5 个月随访时植入物的生存率为 92.8%。临床和功能结果以不同的方式提供。
目前尚无足够的证据推荐或禁忌使用 Merete™ BioBall™ 系统。单纯髋臼翻修是植入物使用的主要适应证。当脱位是其使用适应证时,二次翻修率较高。一些可能与植入物设计有关的重要并发症已经报道,但都是孤立的病例。颈适配器失效或腐蚀现象尚未报道。需要进一步前瞻性和对照试验来评估这种类型植入物的使用及其生存率。
病例系列的 III 级系统评价。