Department of Orthopaedic Surgery, Beaumont Health System, Royal Oak, MI, USA.
J Shoulder Elbow Surg. 2013 Apr;22(4):535-41. doi: 10.1016/j.jse.2012.06.001. Epub 2012 Sep 6.
Aseptic loosening of all-polyethylene glenoid components remains a limiting factor in achieving long-term implant survival in total shoulder arthroplasty (TSA). This study prospectively evaluated the functional and radiographic outcomes of patients undergoing TSA with a novel, porous, tantalum-backed glenoid component, with a minimum 2 years of follow-up.
Porous tantalum-backed glenoid components were used in 19 TSAs in 19 patients. All patients were available for radiographic follow-up at an average of 38 months (range, 24-64 months). Patients were evaluated prospectively using the American Shoulder and Elbow Surgeons (ASES) score and pain on a visual analog scale (VAS). Radiographs were evaluated for component loosening and failure of the porous tantalum backing at a minimum 2 years of follow-up.
The mean VAS decreased from 8.6 to 2.9 (P < .0001). The mean ASES score improved from 21 to 70 points (P < .05). Mean active forward elevation improved from 75° to 131° (P < .0001). At latest follow-up, all glenoid components except 1 had complete in-growth of the porous tantalum keel; however, 4 components (21%) failed by fracture at the keel-glenoid face junction.
There was an unacceptably high rate of glenoid component failure (21%) due to fracture at the keel-glenoid face junction in this series. The manufacturer has subsequently revised this early design to reduce the risk of failure. The results of this study illustrate that caution should be exercised in the use of novel implants with an unproven clinical track record.
在全聚乙烯肩胛盂假体的全肩关节置换术中,无菌性松动仍然是影响假体长期生存率的一个限制因素。本研究前瞻性评估了使用新型多孔钽背衬肩胛盂假体的患者的功能和影像学结果,随访时间至少 2 年。
19 例患者(19 肩)使用多孔钽背衬肩胛盂假体。所有患者在平均 38 个月(24-64 个月)的时间接受了影像学随访。前瞻性采用美国肩肘外科医师协会(ASES)评分和视觉模拟评分(VAS)评估疼痛对患者进行评估。至少随访 2 年,评估影像学上的假体松动和多孔钽背衬失败情况。
VAS 评分从 8.6 分降至 2.9 分(P <.0001)。ASES 评分从 21 分提高至 70 分(P <.05)。主动前屈活动度从 75°提高至 131°(P <.0001)。末次随访时,除 1 例外所有肩胛盂假体的多孔钽龙骨均完全骨长入,但 4 例(21%)在龙骨-肩胛盂界面处发生骨折而失败。
本系列中,由于龙骨-肩胛盂界面处骨折导致肩胛盂假体失败率(21%)较高。制造商随后对早期设计进行了修改,以降低失败风险。本研究结果表明,对于具有未知临床记录的新型植入物应谨慎使用。