To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component. Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed.Aims
Methods
Glenoid failure remains the most common mode of total shoulder arthroplasty failures. Porous tantalum metal (Trabecular Metal™, Zimmer) have grown in popularity in hip and knee arthroplasty. First-generation porous tantalum metal-backed glenoid components demonstrated metal debris, resulted in failure, and were revised to second-generation glenoid implants. Evidence for second-generation porous tantalum metal implants in shoulder arthroplasty is sparse.1–4 The purpose of this study was to assess clinical and radiographic outcomes in a series of patients with second-generation porous tantalum glenoid components at a minimum two-years postoperative. We retrospectively reviewed the clinical and radiographic outcomes of patients who received a second-generation porous tantalum glenoid component anatomic shoulder arthroplasty between May 2009 and December 2017 with minimum 24 months follow-up. The shoulder arthroplasties were performed by one of two senior fellowship-trained surgeons. We collected postoperative clinical outcome indicators: EQ5D visual analog scale (VAS), Western Ontario Osteoarthritis of the Shoulder (WOOS) Index, American Shoulder and Elbow Surgeons (ASES) Score, and Constant Score (CS). Radiographic review was performed by an independent fellowship-trained surgeon. The Endrizzi metal debris grading system1 was utilized to grade metal debris. We computed descriptive statistics and compared outcome scores between groups via the non-parametric Wilcoxon rank-sum test, with group-wise comparisons defined by: metal debris and humeral head migration (secondary analyses). Thirty-five patients [23 male (65.7%) and 12 female (34.3%)] with 40 shoulder replacements participated in the study. Forty of 61 shoulders (65.6%) had an average of 64 ± 20.3 months follow-up (range 31 to 95). Average BMI was 27.5 ± 4.4 kg/m2 (range 19.5 to 39.1). The average postoperative EQ5D VAS at final follow-up was 74.6 ± 22.5, WOOS Index 87.9 ± 16.6, ASES Score 88.3 ± 10.9, and CS 80.4 ± 13. At final follow-up, 18 of 40 shoulders (45%) had metal debris [15 of 40 (37.5%) Endrizzi grade 1 and three of 40 (7.5%) Endrizzi grade 2], and 22 of 40 shoulders (55%) did not show evidence of metal debris. There was one non-revision reoperation (open subscapularis exploration), one shoulder with anterosuperior escape, three shoulders with glenoid radiolucencies indicative of possible glenoid loosening, and nine shoulders with superior migration of the humeral head (>2mm migration at final follow-up compared to immediate postoperative). When comparing postoperative scores between patients with vs without metal debris, we found no statistically significant difference in the EQ5D VAS, WOOS Index, ASES Score and CS. On further analyses, when comparing superior migration of the humeral head and postoperative outcomes scores, we found no statistically significant difference. We report the longest published follow-up with clinical and radiographic outcomes of second-generation porous tantalum glenoid anatomic shoulder arthroplasties. In this series of patients, 45% of total shoulder arthroplasties with a second-generation porous tantalum glenoid implant had radiographic evidence of metal debris. This metal debris was not statistically associated with poorer postoperative outcomes. Further investigation and ongoing follow-up are warranted.