METHODS: This retrospective multicenter study examined prospective data of patients undergoing total anatomic arthroplasty with ISA Stemless implant and followed up at least 2 years. Clinical assessment included preoperative and final follow-up measurements of active range of motion (ROM), Constant score, and Subjective Shoulder Value (SSV). Anatomical epiphyseal reconstruction and bone remodeling at the 2-year follow-up were assessed by standardized Computed Tomography Scanner (CT scan). Statistical analysis employed unpaired Student\'s t-test or chi-squared test depending on the variable type, conducted using EasyMedStat software (version 3.22; www.easymedstat.com).
RESULTS: Fifty patients (mean age 68 years, 62% females) were enrolled, with an average follow-up of 31 months (24-44). Primary osteoarthritis (68%) with type A glenoid (78%) was the prevailing indication. The mean Constant score and SSV improved significantly from 38 ± 11 to 76 ± 11 (p<0.001) and from 31% ± 16 to 88% ± 15 (p<0.001) respectively at the last follow-up. Forward elevation, external rotation and internal rotation ROM increased by 39° ± 42, 28° ± 21 and 3,2 ± 2,5 points respectively, surpassing the Minimally Clinically Important Difference (MCID) after total shoulder arthroplasty. No revisions were necessary. CT scans identified 30% osteolysis in the posterior-medial calcar region, devoid of clinical repercussions. No risk factors were associated with bone osteolysis.
CONCLUSIONS: At an average follow-up of 31 months, ISA Stemless implant provided favorable clinical results. CT analysis revealed osteolysis-like remodeling in the posterior-medial zone of the calcar (30%), without decline in clinical outcomes and revisions. Long-term follow-up studies are mandated to evaluate whether osteolysis is associated with negative consequences.
方法:这项回顾性多中心研究检查了接受ISA无茎植入物全解剖关节成形术患者的前瞻性数据,并随访了至少2年。临床评估包括术前和最终随访测量活动范围(ROM),恒定的分数,和主观肩值(SSV)。通过标准化计算机断层扫描(CT扫描)评估2年随访时的解剖骨重建和骨重建。根据变量类型,采用不成对学生t检验或卡方检验进行统计分析,使用EasyMedStat软件(版本3.22;www.easymedstat.com)。
结果:50名患者(平均年龄68岁,62%的女性)被登记,平均随访31个月(24-44)。原发性骨关节炎(68%)与A型关节盂(78%)是主要适应症。在最后一次随访时,平均Constant评分和SSV分别从38±11显著改善至76±11(p<0.001)和从31%±16显著改善至88%±15(p<0.001)。向前高程,外旋转和内旋转ROM分别增加了39°±42、28°±21和3,2±2,5点,超越全肩关节置换术后最小临床重要差异(MCID)。没有必要进行修改。CT扫描发现后内侧cal区30%的骨溶解,没有临床影响。没有危险因素与骨溶解相关。
结论:平均随访31个月,ISA无茎植入物提供了良好的临床结果。CT分析显示cal骨后部-内侧区有骨质溶解样重塑(30%),没有临床结果和修订的下降。长期随访研究被要求评估骨质溶解是否与负面后果有关。