Cost-utility analysis of total shoulder arthroplasty: a prospective health economic study using real-world data.

BACKGROUND: With increasing health care expenditures, knowledge about the benefit and costs of surgical interventions such as total shoulder arthroplasty (TSA) becomes important for orthopedic surgeons, social insurance programs, and health policy decision makers. We examined the impact of TSA on quality of life (QOL), direct medical costs, and productivity losses and evaluated the cost-utility ratio of TSA compared with ongoing nonoperative management using real-world data. METHODS: Patients with shoulder osteoarthritis and/or rotator cuff tear arthropathy indicated for anatomic or reverse TSA were included in this prospective study. QOL (European Quality of Life 5 Dimensions 5-Level questionnaire) and shoulder function (Constant score; Shoulder Pain and Disability Index; short version of the Disabilities of the Arm, Shoulder and Hand questionnaire; and Subjective Shoulder Value) were assessed preoperatively and up to 2 years postoperatively. Health insurance companies provided all-diagnosis direct medical costs for 2018 in Swiss francs (CHF), where 1 CHF was equivalent to US $1.02. Indirect costs were assessed using the Work Productivity and Activity Impairment Questionnaire. Baseline data at recruitment and the total costs of the preoperative year served as a proxy for nonoperative management. The incremental cost-effectiveness ratio (ICER) was calculated as the total costs to gain 1 extra quality-adjusted life-year (QALY) based on both the health care system perspective and societal perspective. The relationship between QOL and shoulder function was assessed by regression analysis. RESULTS: The mean preoperative utility index for the European Quality of Life 5 Dimensions 5-Level questionnaire of 0.68 for a total of 150 patients (mean age, 71 years; 21% working; 58% women) increased to 0.89 and 0.87 at 1 and 2 years postoperatively, respectively. Mean direct medical costs were 11,771 CHF (preoperatively), 34,176 CHF (1 year postoperatively), and 11,763 CHF (2 years postoperatively). The ICER was 63,299 CHF/QALY (95% confidence interval, 44,391-82,206 CHF/QALY). The mean productivity losses for 29 working patients decreased from 40,574 CHF per patient (preoperatively) to 26,114 CHF at 1 year postoperatively and 10,310 CHF at 2 years postoperatively. When considering these productivity losses, the ICER was 35,549 CHF/QALY (95% confidence interval, 12,076-59,016 CHF/QALY). QOL was significantly associated with shoulder function (P < .001). CONCLUSION: Using real-world direct medical cost data, we calculated a cost-utility ratio of 63,299 CHF/QALY for TSA in Switzerland, which clearly falls below the often-suggested 100,000-CHF/QALY threshold for acceptable cost-effectiveness. In view of productivity losses, TSA becomes highly cost-effective with an ICER of 35,546 CHF/QALY.

Short-term safety, function, and quality of life in patients treated with Univers Revers prosthesis: a multicenter 2-year follow-up case series.

BACKGROUND: The use of reverse total shoulder arthroplasty (RTSA) has dramatically increased in recent years with the advent of new prosthesis designs regularly entering the market. We define the rate of local complications during the first 2 years after RTSA with the Univers Revers prosthesis and describe the changes in radiologic outcomes, as well as function, pain, satisfaction, and quality of life. METHODS: This multicenter, prospective case series included rotator cuff tear arthropathy patients who underwent RTSA with the Univers Revers. Incidence percentages of complications and pathologic radiographic changes were documented. Mixed-model linear regression was used to examine changes in range of motion, shoulder function (Constant score, Shoulder Pain and Disability Index, Subjective Shoulder Value), and quality of life (EQ-5D-5L [European Quality of Life 5 Dimensions 5 Level] and EQ-VAS [EuroQol Visual Analog Scale]). RESULTS: Of 187 patients, 59.4% were women, and the mean age was 75.3 years (range, 56-91 years). Twenty-five percent of patients had a postoperative complication; 5 complications were severe (2.7%, 5 of 187), whereby 2 were implant related (1.1%; 95% confidence interval [CI], 0.1%-3.8%). The incidence of scapular notching was 10.6% (95% CI, 6.5%-16%). After 2 years, abduction, flexion, and abduction strength improved by 54° (95% CI, 50°-58°), 57° (95% CI, 53°-60°), and 5 kg (95% CI, 4-5 kg), respectively (P < .001), whereas external rotation at 0° (1°; 95% CI, -1° to 3°) did not improve (P = .4). The Constant score improved by 39 (95% CI, 38-41); Shoulder Pain and Disability Index, by 50 (95% CI, 47-52); and Subjective Shoulder Value, by 43 (95% CI, 41-45) (P < .001). Furthermore, the EQ-5D-5L index value improved by 0.31 (95% CI, 0.30-0.33), and the EQ-VAS score improved by 16 (95% CI, 14-18) (P < .001). CONCLUSION: Our case series showed a low complication rate with a consistent clinically relevant and statistically significant improvement across most clinical and patient-reported outcomes for the Univers Revers. Long-term safety requires further investigation.

Porcine Dermis Patch Augmentation of Supraspinatus Tendon Repairs: A Pilot Study Assessing Tendon Integrity and Shoulder Function 2 Years After Arthroscopic Repair in Patients Aged 60 Years or Older.

PURPOSE: To investigate the 2-year postoperative clinical and subjective outcomes after arthroscopic rotator cuff repair (ARCR) with xenologous porcine dermal patch augmentation compared with ARCR alone. METHODS: Patients aged 60 years or older with a complete supraspinatus (SSP) tendon tear underwent primary ARCR with a transosseous-equivalent technique. By use of a matched-pair comparative trial design, a consecutive series of 20 patients receiving additional xenologous porcine dermal patch augmentation (patch group) was matched by tear location with 20 patients who received ARCR only (control group). Prior conservative treatment failed in all patients. Patients with concomitant pathologies precluding accurate repair assessment, partial or open reconstruction, or a latissimus dorsi and/or pectoralis major muscle transfer were excluded. Patients reported daily pain levels for 10 days after surgery. Clinical parameters and various patient-reported outcome scores were documented preoperatively and at 3, 6, and 24 months after surgery. Repair integrity was determined by magnetic resonance imaging or ultrasound at 24 months. Adverse events were recorded. Group outcome differences were analyzed with t tests, Fisher exact tests, and mixed models. RESULTS: Patients in both groups were aged 67 years on average (range, 60-74 years), and 70% of patients were men. Patients in the patch group had slightly more SSP fatty infiltration preoperatively. Patch surgical procedures were on average 22 minutes longer than control interventions (P = .003). At 24 months, 4 patients and 9 patients were diagnosed with a recurrent SSP tendon defect in the control group (n = 20) and patch group (n = 19), respectively (relative risk, 2.4; P = .096). Of 11 defects (85%) identified as medial cuff failure, 8 occurred in the patch group. Pain rated by all patients decreased from postoperative day 1 to day 10 without any significant group difference (P = .348). No significant group differences were noted for other outcome parameters, and recurrent defects had no relevant effect on functional outcomes. Local complications (including recurrent defects) occurred in 8 patients in the control group and 12 in the patch group (P = .343). CONCLUSIONS: Our pilot study supports the view that an SSP tear repair with porcine dermal xenograft augmentation does not benefit patients in terms of reducing the risk of a recurrent tendon defect or improving shoulder function up to 24 months after surgical repair. LEVEL OF EVIDENCE: Level III, therapeutic study, retrospective comparative trial.

Arthroscopic treatment of anterior shoulder instability associated with a HAGL lesion-a case series.

BACKGROUND: Restoration of shoulder stability after humeral avulsion of glenohumeral ligament (HAGL) lesions can be achieved with arthroscopy, yet limited evidence exists on its benefit. We evaluated objective and subjective outcomes after arthroscopic refixation of a HAGL lesion. METHODS: Between 2009 and 2012, 8 patients were treated arthroscopically for anterior shoulder instability associated with a HAGL lesion and invited for a follow-up examination. Radiographic assessment of joint centering and osteoarthritis, clinical assessment including Constant and Rowe scores, and complications as well as functional outcomes using the Western Ontario Shoulder Instability Index, Subjective Shoulder Value, and Simple Shoulder Test were documented. RESULTS: Six patients were postoperatively examined at a median time of 29 months (range, 12-38). Four patients had up to 6 previous luxation events. Two patients had a concomitant labral lesion, and another 2 had an associated rotator cuff tear. Positive preoperative apprehension and relocation test results for 5 patients were negative at follow-up. No neurologic lesion was noted both before and after surgery. Shoulder motion did not improve significantly; lower internal and external rotation relative to the contralateral shoulder was reported. The Rowe score improved significantly from baseline (median score change, 65 points; P = .027), with 2 and 4 patients rating "good" and "excellent" at follow-up, respectively. Final median Constant score, Western Ontario Shoulder Instability Index, Subjective Shoulder Value, and Simple Shoulder Test scores were 77.3 points, 91.0 points, 90%, and 87.5 points, respectively. CONCLUSION: Arthroscopic stabilization of a HAGL lesion is a safe, feasible, and reproducible technique. In our patient cohort, good shoulder stability could be achieved with high patient satisfaction.

Patient-Rated Tennis Elbow Evaluation (PRTEE). / Patient-Rated Tennis Elbow Evaluation (PRTEE).

BACKGROUND: The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis. An official German translation does not yet exist. OBJECTIVES: The aim of this study was to translate and cross-culturally adapt the English version of the PRTEE into German. MATERIAL AND METHODS: The translation and cross-cultural adaptation was completed by an expert committee comprising people of varying professional and linguistic backgrounds. According to international guidelines, the English original was first translated into German, then back-translated and the final version was pre-tested on patients. RESULTS: No major difficulties were encountered during the translation process and smaller linguistic discrepancies could be resolved in the expert committee. For the pre-validation testing, 11 patients with extensor repair due to persistent lateral epicondylitis were included. They rated the questionnaire as easy to understand and complete. The final version was approved by the developers of the original questionnaire as the official German translation. CONCLUSIONS: Although the measurement properties of the German version were not evaluated in this study, the original shows good reliability, validity and responsiveness. In summary, the PRTEE is a questionnaire quick and easy to complete for patients with lateral epicondylitis. Therefore, it is suitable for the clinical routine assessment of subjective health status or the outcome after an intervention.

Does Pure Platelet-Rich Plasma Affect Postoperative Clinical Outcomes After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial.

BACKGROUND: The exact role of platelet-rich plasma (PRP) in rotator cuff tendon reconstruction remains unclear. PURPOSE/HYPOTHESIS: This study investigated whether an intraoperative pure PRP injection, compared with a local anesthetic injection, improves patient-reported outcomes at 3 and 6 months after arthroscopic rotator cuff repair. The hypothesis was that pure PRP improves patient-reported outcomes (Oxford Shoulder Score [OSS]) at 3 and 6 months after surgery and has the same pain-reducing effect compared with a postoperative subacromial local anesthetic (ropivacaine) injection. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Between January 2011 and November 2012, a total of 120 patients who underwent arthroscopic double-row repair of a supraspinatus tendon rupture were randomized to receive either pure PRP by an injection at the footprint (PRP group; n = 60) or ropivacaine injected in the subacromial region (control group; n = 60). Seventy-eight percent of patients had other concomitant tears. All patients, surgeons, and follow-up investigators were blinded. Clinical parameters and various outcome scores (Constant-Murley shoulder score; OSS; patient American Shoulder and Elbow Surgeons score; quick Disabilities of the Arm, Shoulder and Hand score; EuroQol 5 dimensions) were documented preoperatively and at 3, 6, and 24 months postoperatively. The repair integrity was assessed by magnetic resonance imaging or ultrasound at 24 months. Furthermore, a pain diary was completed within the first 10 postoperative days, and adverse events were recorded. Group outcome differences were analyzed using t tests, Fisher exact tests, and mixed models. RESULTS: The final follow-up rate was 91%. An associated tear of the subscapularis tendon was diagnosed in 23% of PRP-treated patients and 36% of control patients. Three months after surgery, the mean (±SD) OSS was 32.9 ± 8.6 in PRP-treated patients and 30.7 ± 10.0 in control patients (P = .221). No significant differences were noted for other outcome parameters as well as at 6 and 24 months postoperatively. Smoking was a significant effect modifier. Pain for both groups decreased from postoperative day 1 to 10 without any significant group difference (P = .864). Six (12.2%) and 11 (20.8%) patients were diagnosed with a recurrent supraspinatus tendon defect in the PRP and control groups, respectively (P = .295). Twenty-two (40.7%) and 18 (30.5%) PRP-treated and control patients, respectively, experienced a local adverse event within 24 months (P = .325). CONCLUSION: Patients treated with pure PRP showed no significantly improved function at 3, 6, and 24 months after arthroscopic repair compared with control patients receiving ropivacaine; however, a similar pain reduction was documented in both groups. The negative influence of smoking on the effect of pure PRP requires further investigation. REGISTRATION: NCT01266226 (ClinicalTrials.gov).