Abstract
Objectives:
Rotator cuff tears (RCTs) are the number one cause of shoulder pain and are becoming increasingly common as the population ages. The increasing incidence of RCTs present a significant economic burden, with shoulder pain being the No. 1 cause of disability in the United States. Repair of RCTs, in return, result in a cumulative $3.4 billion savings annually in the United States.
Historically, follow-up for rotator cuff repair (RCR) mirrors that of hip and knee arthroplasty, with minimum of 2-year outcomes reported in most peer-reviewed studies. Recent literature, however, demonstrates no significant increase in clinically significant improvement after 6 months regarding functional outcomes and patient-reported outcomes (PROs) such as American Shoulder and Elbow Surgeons Shoulder Score (ASES), visual analog scale (VAS), and Disabilities of the Arm, Shoulder, and Hand (DASH) scores among others. The purpose of this study is to demonstrate degradation of outcome improvement in patient-reported outcomes after 1-year follow-up of RCR. We hypothesize that there will be no clinically significant increase in Single Assessment Numeric Evaluation (SANE) scores after 1 year postoperatively. The primary outcome of interest is change in SANE score over the 2-year episode of care.
Methods:
All patients that underwent primary RCR within a single health care system were eligible for inclusion in this study. Exclusion criteria included history of surgery on the affected shoulder, incomplete PROs at baseline, 1 year, or 2 years postoperatively, and concomitant fractures about the affected shoulder. Patient demographics, injury characteristics, and operative technical characteristics were obtained through review of the patients’ electronic medical records and operative reports. PROs included SANE, ASES, and VAS scores and were collected prospectively, then stored in a HIPAA-compliant database until reviewed retrospectively for this study. An anchor-based minimum clinically important difference (MCID) was calculated for the study cohort at 1 and 2 years postoperatively and was anchored on a 1-point increase in the Patient-Reported Outcomes Measurement Information System global 10 quality of life question.
The primary outcomes of interest are baseline (preoperative), 1-year, and 2-year SANE scores. Secondary outcomes of interest included rates of symptomatic retear, reoperation, and revision. Statistical analysis was performed with a statistical analysis software (Intellectus). Analyses included descriptive statistics, t tests, chi-square tests of independence, Fischer exact tests, and analyses of variance, as appropriate. Statistical significance was defined as an alpha value of p ≤ 0.05.
Results:
A total of 495 patients met criteria for inclusion in the study (Table 1). The average age of the study population was 61.5 ± 8.4 years old, and the average body mass index (BMI) was 29.9 ±5.5. Most patients were men (287, 58.0%). A total of 24 patients were under workers’ compensation. Other medical comorbidities of interest included diabetes (74, 15.0%), depression (85, 17.2%), anxiety (74, 15.0%), and rheumatoid arthritis (6, 1.2%). Just over half of patients had chronic tears as described by the surgeon in clinical notes or operative reports (259, 52.3%), and most patients had full-thickness tears documented in the operative report (402, 81.2%). The most common adjuvant procedures included subacromial decompression (SAD) (419, 84.6%), biceps tenodesis (211, 42.6%) and distal clavicle excision (DCE) (133, 26.9%).
Baseline SANE scores for the study cohort averaged 40.8 ± 20.3 with a subsequent of 43.4 within the first year postoperatively, bringing the 1-year SANE average to 84.1 ± 196 (p < 0.001). After the 1-year follow-up, however, there was small but statistically significant change in SANE scores with the 2-year SANE scores averaging 87.5 ± 18.1, p < 0.001) (Figure 1). One-year anchor-based MCID for SANE was found to be 45.5, with 238 (48.1%) meeting this MCID. At 2-years, 213 patients (43.0%) met the MCID of 50.6.
Conclusions:
Over the 2-year episode of care following primary RCR, patients saw an overall increase in SANE of 46.8. Even after the 1-year follow-up, patients continued to see statistically significant increases in SANE scores; however, they did not see clinically significant increase in PROs, as demonstrated by fewer patients meeting the 2-year MCID compared with the 1-year MCID.
