Editorial Commentary: Bioinductive Collagen Implants Reduce Rotator Cuff Retear, yet Cost-Effectiveness and Improvement in Clinical Outcomes Are Unclear.

The estimated health care costs of failed arthroscopic rotator cuff retears (RCRs) performed in the United States represent a huge economic burden of greater than $400 million per 2-year period. Unfortunately, retear rates do not appear to have improved significantly since the 1980s, despite advances in surgical technology and the biomechanics of repair. The failure of these advances to translate into improved clinical results suggests that the limiting step in reducing retear rates is biology rather than the biomechanics of repair. Bioinductive collagen implants (BCIs) are an emerging and potentially useful option for biological augmentation. Recent meta-analysis of preclinical and clinical studies demonstrates that biological augmentation significantly lowers the risk of retear. Retrieval studies from human RCR subjects who underwent treatment with BCI demonstrate cellular incorporation, tissue formation, and maturation, providing a logical basis for a reduction in retear rates as well as small increases in tendon thickness at the footprint. Although BCIs show potential as a possible game-changing solution for reducing failure rates of RCR, concerns remain regarding cost-effectiveness analyses and demonstration of functional outcome improvement.

Ambulatory Surgery Centers Reduce Patient Out-of-Pocket Expenditures for Isolated Arthroscopic Rotator Cuff Repair, but Patient Out-of-Pocket Expenditures Are Increasing at a Faster Rate Than Total Healthcare Utilization Reimbursement From Payers.

PURPOSE: To categorize and trend annual out-of-pocket expenditures for arthroscopic rotator cuff repair (RCR) patients relative to total healthcare utilization (THU) reimbursement and compare drivers of patient out-of-pocket expenditures (POPE) in a granular fashion via analyses by insurance type and surgical setting. METHODS: Patients who underwent outpatient arthroscopic RCR in the United States from 2013 to 2018 were identified from the IBM MarketScan Database. Primary outcome variables were total POPE and THU reimbursement, which were calculated for all claims in the 9-month perioperative period. Trends in outcome variables over time and differences across insurance types were analyzed. Multivariable analysis was performed to investigate drivers of POPE. RESULTS: A total of 52,330 arthroscopic RCR patients were identified. Between 2013 and 2018, median POPE increased by 47.5% ($917 to $1,353), and median THU increased by 9.3% ($11,964 to $13,076). Patients with high deductible insurance plans paid $1,910 toward their THU, 52.5% more than patients with preferred provider plans ($1,253, P = .001) and 280.5% more than patients with managed care plans ($502, P = .001). All components of POPE increased over the study period, with the largest observed increase being POPE for the immediate procedure (P = .001). On multivariable analysis, out-of-network facility, out-of-network surgeon, and high-deductible insurance most significantly increased POPE. CONCLUSIONS: POPE for arthroscopic RCR increased at a higher rate than THU over the study period, demonstrating that patients are paying an increasing proportion of RCR costs. A large percentage of this increase comes from increasing POPE for the immediate procedure. Out-of-network facility status increased POPE 3 times more than out-of-network surgeon status, and future cost-optimization strategies should focus on facility-specific reimbursements in particular. Last, ambulatory surgery centers (ASCs) significantly reduced POPE, so performing arthroscopic RCRs at ASCs is beneficial to cost-minimization efforts. CLINICAL RELEVANCE: This study highlights that although payers have increased reimbursement for RCR, patient out-of-pocket expenditures have increased at a much higher rate. Furthermore, this study elucidates trends in and drivers of patient out-of-pocket payments for RCR, providing evidence for development of cost-optimization strategies and counseling of patients undergoing RCR.

Cost of Arthroscopic Rotator Cuff Repairs Is Primarily Driven by Procedure-Level Factors: A Single-Institution Analysis of an Ambulatory Surgery Center.

PURPOSE: To identify intraoperative drivers of cost associated with arthroscopic rotator cuff repairs (RCRs) through analysis of an institutional database. METHODS: This was a single-institution retrospective review of arthroscopic RCRs performed at an ambulatory surgical center between November 2016 and July 2019. Patient-level factors analyzed included age, sex, insurance type (private, Medicare, Medicaid, self-pay, and other government), American Society of Anesthesiologists grade (I, II, III, and missing), and Charlson comorbidity index (0, 1, 2, and ≥3). Procedure-level factors included use of biologics (decellularized dermal allograft or bioinductive healing implant), anesthesia type (regional block, monitored anesthesia care, or general), number of anchors and sutures, additional procedures (biceps tenodesis, distal clavicle resection, subacromial decompression), and operative time. Multivariate linear regression analysis was used to identify factors significantly associated with higher or lower charges. RESULTS: A total of 712 arthroscopic RCRs were included. The risk-adjusted operative charges were $19,728 (95% confidence interval $16,543 to $22,913). The above factors predicted nearly 65% of the variability in operative charges. The only patient-level factor significantly associated with lower charges was female sex (- $1,339; P = .002). Procedure-level factors significantly associated with higher charges were use of biologics (+ $17,791; P < .001), concurrent open biceps tenodesis (+ $4,027; P < .001), distal clavicle resection (+ $2,266; P = .039), use of regional block (+ $1,256; P = .004), number of anchors (+ $2,245/anchor; P < .001), and increasing operative time ($26/min). Other factors had no significant association. CONCLUSIONS: Procedural factors are the most significant drivers of operative cost in arthroscopic RCRs, such as quantity and type of implants; additional procedures such as biceps tenodesis and distal clavicle resection; and perioperative conditions such as type of anesthesia and total operating room time. Overall, patient-level factors were not shown to correlate well with operative costs, other than lower charges with female sex. LEVEL OF EVIDENCE: IV, economic study.

The Cost of Outpatient Arthroscopic Rotator Cuff Repairs: Hospital Reimbursement Is on the Rise While Surgeon Payments Remain Unchanged.

PURPOSE: To better understand the relative increases in rotator cuff charges and to analyze national and regional trends between hospital, anesthesiologist, and surgeon charges and reimbursements for contemporary rotator cuff repairs (RCRs) performed in the United States. METHODS: A representative Medicare sample was used to capture hospital, surgeon, and anesthesiologist charges and payments for outpatient RCR from 2005 to 2014. The charges and reimbursements were calculated using Current Procedural Terminology codes. Two ratios were calculated to compare surgeon and hospital charges and reimbursements. The charge multiplier (CM) is the ratio of hospital to surgeon charges, and the payment multiplier (PM) is the ratio of hospital to surgeon reimbursements. Trends were evaluated using national and regional charges, reimbursements, Charlson Comorbidity Index, CM, and PM. RESULTS: In total, 12,617 patients were included in this study. Between 2005 and 2014, hospital charges for RCR significantly increased from $4877 to $11,488 (136% increase; P < .0001), anesthesiologist charges increased from $1319 to $2169 (64% increase; P < .0001), and surgeon charges increased from $7528 to $9979 (33% increase; P < .0001). Reimbursements during the same period significantly increased from $3007 to $6696 (123% increase; P < .0001) for hospitals, from $203 to $239 (17% increase; P = .005) for anesthesiologists. Reimbursements for surgeons remained relatively unchanged (from $1821 to $1885, 3% increase; P = .116). Increases in national CM (P = .003) and PM (P < .0001) were both statistically significant. Charlson Comorbidity Index did not change significantly over the period (P = .1178). CONCLUSIONS: Although outpatient RCR charges increased significantly for hospitals, surgeons, and anesthesiologists, hospital reimbursements increased substantially relative to surgeon and anesthesiologist reimbursements despite stable patient complexity. In 2005, hospitals were reimbursed 65% more than surgeons. By 2014, hospitals were reimbursed 255% more than surgeons, indicating that hospitals disproportionally drove increases in charges and reimbursements over this period. LEVEL OF EVIDENCE: Level IV, economic analysis.

Factors Affecting the Cost and Profitability of Arthroscopic Rotator Cuff Repair.

PURPOSE: To examine the cost metrics and profitability of rotator cuff repairs (RCRs) in a large health care system. METHODS: A retrospective study was performed using value analysis team data from 2 hospitals within a large metropolitan health system from 2010 to 2014. Cost and profit metrics were collected and compared against surgeon volume, surgeon subspecialty training, implant costs, Current Procedural Terminology (CPT) coding, length of stay, and hospital site. RESULTS: A total of 5,899 RCRs were identified with a mean contribution margin of $2,133. Surgical supplies were the largest contributor to direct costs. Hospital site also significantly affected contribution margin ($1,912 at hospital 1 vs $3,129 at hospital 2, P < .001). The number of billed CPT codes was not significantly correlated to contribution margin; however, significant differences were noted in contribution margin and direct cost associated with different CPT code combinations, with arthroscopic RCR with subacromial decompression and distal clavicle excision being the most profitable, at an average contribution margin of $2,147. There was no correlation between surgeon volume and contribution margin or direct cost. CONCLUSIONS: Our overall findings show that improvement in the profitability of arthroscopic RCR for hospital systems is possible, both by examining institutions' direct costs and by providing individual surgeons with cost breakdowns and contribution margin information to improve the profitability of their practice. LEVEL OF EVIDENCE: Level IV, economic and decision analysis.

The value of shoulder replacement and rotator cuff surgery: the patients' perspective.

BACKGROUND: With the continued rise in health care costs, value-based care in orthopedics is more important than ever. Health care providers, policymakers, and insurance companies all have input into defining and setting the level of this value. The purpose of this study was to evaluate patient perception of value in rotator cuff repair (RCR) and total shoulder replacement (TSA) using a population composed only of patients who underwent the procedure. METHODS: We were able to obtain complete data from 191 of the 250 patients in the RCR cohort and 211 of the 250 patients in the TSA cohort. Patients were asked what they believe a surgeon should be reimbursed for performing RCR or TSA, what they would be willing to pay for the procedure, and to rate the importance of each aspect of their care. Patients then estimated what Medicare reimbursed for the procedure they underwent. RESULTS: The mean result for patients surveyed regarding a reasonable fee for surgeons was $9870 for RCR and $14,231 for TSA. The mean patient estimate for actual Medicare reimbursement was $5705 for RCR and $9372 for TSA. Fifty-seven percent thought that payment for RCR was too low, and 76% thought that it was too low for TSA. When asked to rate the importance of each aspect of their care, RCR patients felt that 46% should go to the surgeon. TSA patients felt that surgeons should receive 47%. CONCLUSION: In agreement with prior studies, patients perceived the monetary value of RCR and TSA to be much higher than current Medicare schedules.

An analysis of costs associated with shoulder arthroplasty.

BACKGROUND: The purpose of this study was to identify factors associated with variation in direct costs with shoulder arthroplasty. METHODS: This was a retrospective study of all shoulder arthroplasties performed at a single facility between July 1, 2011, and November 30, 2016. We collected patient factors, indications, procedure (including implant details), implant brand (A, B, and other), and complications. We collected direct costs over a 90-day period using a validated internal tool. We identified patient and procedure characteristics associated with costs using multivariable generalized linear models. RESULTS: A total of 361 patients were included, 19% with revision arthroplasty procedures, 32% with anatomic total shoulder arthroplasties, and 66% with reverse total shoulder arthroplasties (RTSAs). Of total costs, 13% were operative facility utilization costs and 58% were operative supply costs. Factors associated with increased total cost included younger age (P = .002) and an indication for surgery of other, that is, not osteoarthritis, a failed arthroplasty, or the sequelae of a rotator cuff tear (P = .030). Factors associated with increased operative costs included younger age (P = .002), use of an RTSA (P < .001), use of a bone graft (P < .001), implant brand B (P = .098), implant brands other than A and B (P = .04), the sequelae of a rotator cuff tear as an indication for surgery (P = .041), or an indication for surgery of other (P = .007). CONCLUSION: Most short-term (90-day) costs with shoulder arthroplasty are operative costs. Nonmodified factors associated with increased cost included younger age and less common indications for surgery, whereas potentially modifiable factors included the intraoperative use of a bone graft, implant brand, and RTSA use.

The primary cost drivers of arthroscopic rotator cuff repair surgery: a cost-minimization analysis of 40,618 cases.

BACKGROUND: An estimated 250,000 rotator cuff repair (RCR) surgical procedures are performed every year in the United States. Although arthroscopic RCR has been shown to be a cost-effective operation, little is known about what specific factors affect the overall cost of surgery. This study examines the primary cost drivers of RCR surgery in the United States. METHODS: Univariate analysis was performed to determine the patient- and surgeon-specific variables for a multiple linear regression model investigating the cost of RCR surgery. The 2014 State Ambulatory Surgery and Services Databases were used, yielding 40,618 cases with Current Procedural Terminology code 29827 ("arthroscopic shoulder rotator cuff repair"). RESULTS: The average cost of RCR surgery was $25,353. Patient-specific cost drivers that were significant under multiple linear regression included black race (P < .001), presence of at least 1 comorbidity (P < .001), income quartile (P < .001), male sex (P = .012), and Medicare insurance (P = .035). Surgical factors included operative time (P < .001), use of regional anesthesia (P < .001), quarter of the year (January to March, April to June, July to September, and October to December) (P < .001), concomitant subacromial decompression or distal clavicle excision (P < .001), and number of suture anchors used (P < .001). The largest cost driver was subacromial decompression, adding $4992 when performed alongside the RCR. CONCLUSION: There are several patient-specific variables that can affect the cost of RCR surgery. There are also surgeon-controllable factors that significantly increase cost, most notably subacromial decompression, distal clavicle excision, use of regional anesthesia, and number of suture anchors. Surgeons must consider these factors in an effort to minimize cost, particularly as bundled payments become more common.

Comparative cost-effectiveness analysis of the subacromial spacer for irreparable and massive rotator cuff tears.

PURPOSE: There is ongoing debate regarding the optimal surgical treatment of irreparable rotator cuff tears (IRCT). This study aimed to assess within the Italian health care system the cost-effectiveness of subacromial spacer as a treatment modality for patients with IRCT. METHODS: An expected-value decision analysis was created comparing costs and outcomes of patients undergoing arthroscopic subacromial spacer implantation, rotator cuff repair (RCR), total shoulder arthroplasty, and conservative treatment for IRCTs. A broad literature search provided input data to extrapolate and inform treatment success and failure rates, costs, and health utility states for these outcomes. The primary outcome assessed was an incremental cost-effectiveness ratio (ICER) of subacromial spacer implantation versus shoulder arthroplasty, RCR, and conservative treatment. RESULTS: Subacromial spacer is favorable over both arthroscopic partial repair and shoulder arthroplasty since it costs less than both options and increases effectiveness by 0.06 and 0.10 quality-adjusted life years (QALYs), respectively. While conservative treatment is the least costly management strategy, subacromial spacer results in a gain of 0.05 QALYs for the additional cost of 522 €, resulting in an ICER of 10,440 €/QALY gain, which is below the standard willingness to pay ratio of $50,000 USD. Strategies with an ICER of less than 50,000 USD are considered to be cost-effective. CONCLUSIONS: Based on the available evidence and reasonably conservative assumptions, subacromial spacer is likely to provide a safe, effective, and cost-effective option for patients with massive IRCTs. Furthermore, this cost-effectiveness analysis may ultimately serve as a guide for development of health care system and insurer policy as well as clinical practice.

Factors influencing direct clinical costs of outpatient arthroscopic rotator cuff repair surgery.

BACKGROUND: Very limited information exists about factors affecting direct clinical costs of rotator cuff repair surgery. The purpose of this study was to determine the direct cost of outpatient arthroscopic rotator cuff repair surgery using a unique value-driven outcomes tool and to identify patient- and treatment-related variables affecting cost. METHODS: Cost data were derived for arthroscopic rotator cuff repairs performed by 3 surgeons from March 2014 to June 2015 using the value-driven outcomes tool. Costs included overall total direct cost, which included facility utilization costs, medication costs, supply costs, and other ancillary costs. Univariate and multivariate regressions were performed to determine the effect of various patient-related and surgical-related factors on costs. RESULTS: There were 170 arthroscopic rotator cuff repairs performed during the study period. Multivariate analysis showed significant correlations between higher total direct cost and the presence of a subscapularis repair being performed (P = .015) and total number of anchors used (P < .0001). Higher body mass index, severe systemic illness, 1 of the 3 surgeons, biceps tenodesis using an anchor, and total sum of anchors were correlated with higher facility utilization costs (P < .04). Severe systemic illness, addition of a subscapularis repair, 1 of the 3 surgeons, and additional subacromial decompression were correlated with higher pharmacy costs (P < .006). The addition of a subscapularis repair, total sum of anchors, and severe muscle changes to the supraspinatus were correlated with higher supply costs (P < .015). CONCLUSIONS: From a direct cost perspective, implementation of strategies to reduce overall costs should focus on reducing overall anchor quantity or price.

The burden of rotator cuff surgery in Italy: a nationwide registry study.

PURPOSE: This study aimed to estimate the yearly number of RC surgeries in Italy, a country with universal access to healthcare for its population, from 2001 to 2014, based on official information source as hospitalization records. A secondary aim was to explore geographical variation in equity in access to RC surgery between three macroregions of Italy (North, Center and South). A tertiary aim was to perform statistical projections of the number of RC procedure volumes and rates on the basis of data from 2001 to 2014. Finally, we aimed to perform a prediction of charges by 2025 to examine the economic impact of RC surgery. METHODS: The analysis of the National Hospital Discharge records (SDO) maintained at the Italian Ministry of Health, concerning the 14 years of our survey (2001 through 2014) was performed. These data are anonymous and include the patient's age (in aggregate for class of age), sex, domicile, region of hospitalization, length of the hospitalization, and type of reimbursement (public or private). RESULTS: During the 14-year study period, 390,001 RC repairs were performed in Italy, which represented an incidence of 62.1 RC procedures for every 100,000 Italian inhabitants over 25 years old. Approximately 65% of RC repair were performed annually in patients ages <65 years, thus affecting the working population. 246,810 patients (63.3%) from the North underwent RC repairs from 2001 through 2014, 78,540 patients (20.2%) from the Center, and 64,407 patients (16.5%) from the South. The projection model predicted substantial increases in the numbers of RC repairs. CONCLUSIONS: This study confirms that the socioeconomic burden of RC surgery is growing and heavily affecting the working population. According to the prediction model, hospital costs sustained by the national health care system for RC procedures are expected to be over 1 billion euros by 2025. LEVEL OF EVIDENCE: II.

Cost-Effectiveness of Reverse Total Shoulder Arthroplasty Versus Arthroscopic Rotator Cuff Repair for Symptomatic Large and Massive Rotator Cuff Tears.

PURPOSE: To compare the cost-effectiveness within the United States health care system of arthroscopic rotator cuff repair versus reverse total shoulder arthroplasty in patients with symptomatic large and massive rotator cuff tears without cuff-tear arthropathy. METHODS: An expected-value decision analysis was constructed comparing the costs and outcomes of patients undergoing arthroscopic rotator cuff repair and reverse total shoulder arthroplasty for large and massive rotator cuff tears (and excluding cases of cuff-tear arthropathy). Comprehensive literature search provided input data to extrapolate costs and health utility states for these outcomes. The primary outcome assessed was that of incremental cost-effectiveness ratio (ICER) of reverse total shoulder arthroplasty versus rotator cuff repair. RESULTS: For the base case, both arthroscopic rotator cuff repair and reverse total shoulder were superior to nonoperative care, with an ICER of $15,500/quality-adjusted life year (QALY) and $37,400/QALY, respectively. Arthroscopic rotator cuff repair was dominant over primary reverse total shoulder arthroplasty, with lower costs and slightly improved clinical outcomes. Arthroscopic rotator cuff repair was the preferred strategy as long as the lifetime progression rate from retear to end-stage cuff-tear arthropathy was less than 89%. However, when the model was modified to account for worse outcomes when reverse shoulder arthroplasty was performed after a failed attempted rotator cuff repair, primary reverse total shoulder had superior outcomes with an ICER of $90,000/QALY. CONCLUSIONS: Arthroscopic rotator cuff repair-despite high rates of tendon retearing-for patients with large and massive rotator cuff tears may be a more cost-effective initial treatment strategy when compared with primary reverse total shoulder arthroplasty and when assuming no detrimental impact of previous surgery on outcomes after arthroplasty. Clinical judgment should still be prioritized when formulating treatment plans for these patients. LEVEL OF EVIDENCE: Level II, economic decision analysis.

Comparison of implant cost and surgical time in arthroscopic transosseous and transosseous equivalent rotator cuff repair.

BACKGROUND: We investigated the cost savings associated with arthroscopic transosseous (anchorless) double-row rotator cuff repair compared with double-row anchored (transosseous-equivalent [TOE]) repair. METHODS: All patients undergoing double-row arthroscopic rotator cuff repair from 2009 to 2012 by a single surgeon were eligible for inclusion. The study included 2 consecutive series of patients undergoing anchorless or TOE repair. Excluded from the study were revision repairs, subscapularis repairs, patients with poor tendon quality or excursion requiring medialized repair, and partial repairs. Rotator cuff implant costs (paid by the institution) and surgical times were compared between the 2 groups, controlling for rotator cuff tear size and additional procedures performed. RESULTS: The study included 344 patients, 178 with TOE repairs and 166 with anchorless repairs. Average implant cost for TOE repairs was $1014.10 ($813.00 for small, $946.67 for medium, $1104.56 for large, and $1507.29 for massive tears). This was significantly more expensive compared with anchorless repairs, which averaged $678.05 ($659.75 for small, $671.39 for medium, $695.55 for large, and $716.00 for massive tears). Average total operative time in TOE and anchorless groups was not significantly different (99 vs. 98 minutes). There was larger (although not statistically significant) case time variation in the TOE group. CONCLUSIONS: Compared with TOE repair, anchorless rotator cuff repair provides substantial implant-related cost savings, with no significant differences in surgical time for medium and large rotator cuff tears. Case time for TOE repair varied more with extremes in tear size.

Clinical outcomes and direct cost analysis of rotator cuff repair surgery.

OBJECTIVE: The purpose of this study was to evaluate the clinical and functional outcomes in patients who underwent surgical treatment for rotator cuff tears using open and arthroscopic techniques, and to evaluate the direct costs involved. METHODS: Retrospective cohort study with analysis of the data of patients who were referred to two private hospitals in Sao Paulo, Brazil for surgical repair of the rotator cuff from January 2018 to September 2019. Clinical outcomes were assessed using functional scores (SPADI and QuickDASH) and a quality of life questionnaire (EuroQoL). Procedure costs were calculated relative to each hospital's costliest procedure. RESULTS: Data from 362 patients were analyzed. The mean patient age was 57 years (SD= 10.46), with a slight male predominance (53.9%). Arthroscopic procedures were more common than open procedures (95.6% versus 4.4%). Significant clinical improvement was reported in 84.8% of the patients. The factors associated with increased surgery costs were arthroscopic technique (increase of 29.2%), age (increase of 0.6% per year), and length of stay (increase of 18.9% per day of hospitalization). CONCLUSION: Rotator cuff repair surgery is a highly effective procedure, associated with favorable clinical outcomes and improvement in life quality, and low rates of complications. Arthroscopic surgery tends to be costlier than open surgery.

Does Reusable Instrumentation for Four-Anchor Rotator Cuff Repair Offer Decreased Waste Disposal Costs and Lower Waste-Related Carbon Emissions?

INTRODUCTION: Orthopaedic surgery is culpable, in part, for the excessive carbon emissions in health care partly due to the utilization of disposable instrumentation in most procedures, such as rotator cuff repair (RCR). To address growing concerns about hospital waste, some have considered replacing disposable instrumentation with reusable instrumentation. The purpose of this study was to estimate the cost and carbon footprint of waste disposal of RCR kits that use disposable instrumentation compared with reusable instrumentation. METHODS: The mass of the necessary materials and their packaging to complete a four-anchor RCR from four medical device companies that use disposable instrumentation and one that uses reusable instrumentation were recorded. Using the cost of medical waste disposal at our institution ($0.14 per kilogram) and reported values from the literature for carbon emissions produced from the low-temperature incineration of noninfectious waste (249 kgCO 2 e/t) and infectious waste (569 kgCO 2 e/t), we estimated the waste management cost and carbon footprint of waste disposal produced per RCR kit. RESULTS: The disposable systems of four commercial medical device companies had 783%, 570%, 1,051%, and 478%, respectively, greater mass and waste costs when compared with the reusable system. The cost of waste disposal for the reusable instrumentation system costs on average $0.14 less than the disposable instrumentation systems. The estimated contribution to the overall carbon footprint produced from the disposal of a RCR kit that uses reusable instrumentation was on average 0.37 kg CO2e less than the disposable instrumentation systems. CONCLUSION: According to our analysis, reusable instrumentation in four-anchor RCR leads to decreased waste and waste disposal costs and lower carbon emissions from waste disposal. Additional research should be done to assess the net benefit reusable systems may have on hospitals and the effect this may have on a long-term decrease in carbon footprint. LEVEL OF EVIDENCE: Level II.

Non-inferiority and cost-effectiveness trial of isolated biceps tenotomy versus tenotomy with rotator cuff repair in patients with stage 2-3 Goutallier fatty degenerative cuff lesions (TenCuRe study): protocol of a multicentre randomised controlled trial.

INTRODUCTION: For patients who are diagnosed with lesions of the rotator cuff that present advanced levels of fatty degeneration, arthroscopic repair of the rotator cuff remains controversial. This controversy can be attributed to the frequently reported high failure rate of the tendon fixation and the fact that it remains unclear why repair for these tears results in significant clinical improvement independent of the occurrence of such a re-tear. Recent publications have reported comparable clinical improvements when merely a tenotomy of the long head of the biceps tendon was performed and the rotator cuff tear was left untreated. These observations raise questions on the value of performing the more extensive cuff repairs in degenerative cuff tears. Even more, rehabilitation after an isolated tenotomy is much less cumbersome as compared with rehabilitation after rotator cuff repair and, therefore, might result in improved patient satisfaction. The goal of this trial is to study function and quality-of-life of patients undergoing arthroscopic biceps tenotomy with or without an additional cuff repair and to include an economic evaluation. METHODS AND ANALYSIS: This multicentre randomised controlled non-inferiority trial, including an economic evaluation, is designed to compare the short-term and long-term outcome of patients who underwent an arthroscopic tenotomy of the long head of the biceps tendon with or without a cuff repair. We will include 172 patients with stage 2-3 Goutallier fatty infiltration cuff tears and with clinical symptoms of biceps pathology. Primary outcome is the rotator cuff specific quality-of-life (Western Ontario Rotator Cuff index) on the short term (6 months postoperatively). Secondary outcomes are quality-of-life 1, 2 and 5 year postoperatively and function (Constant-Murley score, glenohumeral range of motion), recovery status, pain (visual analogue scale), economic evaluation, satisfaction of treatment on the short-term and long-term and re-tear rate at 6 months determined with an ultrasound. ETHICS AND DISSEMINATION: This trial has been approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, the Netherlands (NL54313.100.15) and will be performed in accordance with the Declaration of Helsinki with the Medical Research Involving Human Subjects Act (WMO). The results of this study will be reported in peer-reviewed journals and at (inter)national conferences. Furthermore, we will share our findings with the appropriate guideline committees. TRIAL REGISTRATION NUMBER: The Dutch Trial Registry (NL4010).

Cost-effectiveness and satisfaction following arthroscopic rotator cuff repair: does age matter?.

AIMS: The aim of this study was to investigate the influence of age on the cost-effectiveness of arthroscopic rotator cuff repair. PATIENTS AND METHODS: A total of 112 patients were prospectively monitored for two years after arthroscopic rotator cuff repair using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH), the Oxford Shoulder Score (OSS), and the EuroQol five-dimension questionnaire (EQ-5D). Complications and use of healthcare resources were recorded. The incremental cost-effectiveness ratio (ICER) was used to express the cost per quality-adjusted life-year (QALY). Propensity score-matching was used to compare those aged below and above 65 years of age. Satisfaction was determined using the Net Promoter Score (NPS). Linear regression was used to identify variables that influenced the outcome at two years postoperatively. RESULTS: A total of 92 patients (82.1%) completed the follow-up. Their mean age was 59.5 years (sd 9.7, 41 to 78). There were significant improvements in the mean DASH (preoperative 47.6 vs one-year 15.3; p < 0.001) and OSS scores (26.5 vs 40.5; p < 0.001). Functional improvements were maintained with no significant change between one and two years postoperatively. The mean preoperative EQ-5D was 0.54 increasing to 0.81 at one year (p < 0.001) and maintained at 0.86, two years postoperatively. There was no significant difference between those aged below or above 65 years of age with regards to postoperative shoulder function or EQ-5D gains. Smoking was the only characteristic that significantly adversely influenced the EQ-5D at two years postoperatively (p = 0.005). A total of 87 were promoters and five were passive, giving a mean NPS of 95 (87/92). The total mean cost per patient was £3646.94 and the mean EQ-5D difference at one year was 0.2691, giving a mean ICER of £13 552.36/QALY. At two years, this decreased further to £5694.78/QALY. This was comparable for those aged below or above 65 years of age (£5209.91 vs £5525.67). Smokers had an ICER that was four times more expensive. CONCLUSION: Arthroscopic rotator cuff repair results in excellent patient satisfaction and cost-effectiveness, regardless of age. Cite this article: Bone Joint J 2019;101-B:860-866.

Exploring the Business Case for Improving Quality of Care for Patients With Chronic Rotator Cuff Tears.

BACKGROUND AND OBJECTIVES: Currently, management of patients presenting with chronic rotator cuff tears in Alberta is in need of quality improvements. This article explores the potential impact of a proposed care pathway whereby all patients presenting with chronic rotator cuff tears in Alberta would adopt an early, conservative management plan as the first stage of care; ultrasound investigation would be the preferred tool for diagnosing a rotator cuff tear; and only patients are referred for surgery once conservative measures have been exhausted. METHODS: We evaluate evidence in support of surgery and conservative management, compare care in the current state with the proposed care pathway, and identify potential solutions in moving toward optimal care. RESULTS: A literature search resulted in an absence of indications for either surgical or conservative management. Conservative management has the potential to reduce utilization of public health care resources and may be preferable to surgery. The proposed care pathway has the potential to avoid nearly Can $87 000 in public health care costs in the current system for every 100 patients treated successfully with conservative management. CONCLUSION: The proposed care pathway is a low-cost, first-stage treatment that is cost-effective and has the potential to reduce unnecessary, costly surgical procedures.

The effect of Medicaid payer status on patient outcomes following repair of massive rotator cuff tears.

BACKGROUND: The influence of socioeconomic status and insurance type has not been studied extensively for RCR, particularly not in the high risk massive RCT population. The purpose of this study is to identify relationships between Medicaid payer status and patient outcomes following massive RCR. METHODS: A retrospective review of shoulder surgery database identified 29 patients undergoing massive rotator cuff repair. Patients were stratified based on insurance type into two cohorts, Medicaid (14 patients) and non-Medicaid (15 patients). Missed routine follow-up appointments and comorbidities were recorded and compared between groups. Group comparisons were made for pre- and postoperative patient-reported and functional outcomes. Outcome scores included American Shoulder and Elbow Shoulder Score (ASES), the Penn Shoulder Score, and the Subjective Shoulder Value (SSV). A p value of < 0.05 was considered significant for all statistical analyses. RESULTS: Medicaid patients were on average 7.1 years younger than non-Medicaid patients (49.8 vs. 56.9 years, respectively), and remaining demographics were comparable between groups. Preoperative patient-reported outcomes were only significantly different for ASES and ASES pain (p = 0.010, 0.037). There was excellent average improvement for Medicaid patients but no significant differences compared to non-Medicaid patients for ASES (p = 0.630), PENN scores (p = 0.395), and SSV (p = 0.198). Medicaid patients also had a higher number of missed and canceled appointments (28%) compared to non-Medicaid patients (18%). CONCLUSION: Medicaid coverage will expand to millions of uninsured Americans under current healthcare reform. Medicaid patients with massive RCT appear to significantly improve with surgical treatment.

Double-Row Arthroscopic Rotator Cuff Repair Is More Cost-Effective Than Single-Row Repair.

BACKGROUND: The optimal technique for arthroscopic rotator cuff repair is controversial, and both single and double-row techniques are commonly used. In the current era of increasing costs, health-care delivery models are focusing on the value of care. In this study, we compared the cost-effectiveness of single-row and double-row reconstructions in patients undergoing arthroscopic rotator cuff repair. METHODS: A cost-utility analysis was performed from the perspective of a publicly funded health-care system. Health-care costs, probabilities, and utility values were derived from the published literature. Efficacy data were obtained from a previous randomized controlled trial comparing the effect of single-row (n = 48) or double-row (n = 42) reconstruction among 90 surgical patients. Unit cost data were obtained from a hospital database and the Ontario Schedule of Benefits and Fees. Results are presented as an incremental cost per quality-adjusted life year (QALY) gained. All costs are presented in 2015 Canadian dollars. A series of 1-way and probabilistic sensitivity analyses were performed. RESULTS: Double-row fixation was more costly ($2,134.41 compared with $1,654.76) but was more effective than the single-row method (4.073 compared with 4.055 QALYs). An incremental cost-effectiveness ratio (ICER) was estimated to be $26,666.75 per QALY gained for double-row relative to single-row fixation. A subgroup analysis demonstrated that patients with larger rotator cuff tears (≥3 cm) had a lower ICER, suggesting that double-row fixation may be more cost-effective for larger tears. CONCLUSIONS: Based on the willingness-to-pay threshold of $50,000 per QALY gained, double-row fixation was found to be more cost-effective than single-row. Furthermore, a double-row reconstruction was found to be more economically attractive for larger rotator cuff tears (≥3 cm). LEVEL OF EVIDENCE: Economic and Decision Analysis Level IV. See Instructions for Authors for a complete description of levels of evidence.