Resorbable Bioinductive Collagen Implant Is Cost Effective in the Treatment of Rotator Cuff Tears.

Purpose: This study was conducted to investigate whether the use of resorbable bioinductive collagen implant (RBI) in addition to conventional rotator cuff repair (conventional RCR) is cost-effective when compared to conventional RCR alone, in the treatment of full-thickness rotator cuff tears (FT RCT). Methods: We developed a decision analytic model to compare the expected incremental cost and clinical consequences for a cohort of patients with FT RCT. The probabilities for healing or failure to heal (retear) were estimated from the published literature. Implant and healthcare costs were estimated from a payor's perspective in 2021 U.S. prices. An additional analysis included indirect cost estimations (e.g., productivity losses). Sensitivity analyses explored the effect of tear size, as well as the impact of risk factors. Results: The base case analysis demonstrated that resorbable bioinductive collagen implant + conventional rotator cuff repair results in incremental costs of $232,468 and an additional 18 healed RCTs per 100 treated patients over 1 year. The estimated incremental cost-effectiveness ratio (ICER) is $13,061/healed RCT compared to conventional RCR alone. When return to work was included in the model, RBI + conventional RCR was found to be cost saving. Cost-effectiveness improved with tear size with the largest benefit seen in massive tears compared to large tears, as well as patients at higher risk of retearing. Conclusions: This economic analysis demonstrated that RBI + conventional RCR delivered improved healing rates at a marginal increase in costs when compared to conventional RCR alone and is, therefore, cost-effective in this patient population. Considering indirect costs, RBI + conventional RCR resulted in lower costs compared to conventional RCR alone and is, therefore, deemed to be cost saving. Level of Evidence: Level IV, economic analysis.

Regulatory and Ethical Aspects of Orthobiologic Therapies.

Orthobiologic therapies show significant promise to improve outcomes for patients with musculoskeletal pathology. There are considerable research efforts to develop strategies that seek to modulate the biological environment to promote tissue regeneration and healing and/or provide symptomatic relief. However, the regulatory pathways overseeing the clinical translation of these therapies are complex, with considerable worldwide variation. The introduction of novel biologic treatments into clinical practice raises several ethical dilemmas. In this review, we describe the process for seeking approval for biologic therapies in the United States, Europe, and Japan. We highlight a number of ethical issues raised by the clinical translation of these treatments, including the design of clinical trials, monitoring outcomes, biobanking, "off-label" use, engagement with the public, marketing of unproven therapies, and scientific integrity.

Intra-articular placebo effect in the treatment of knee osteoarthritis: a survey of the current clinical evidence.

Knee osteoarthritis (KOA) is a debilitating disease characterized by chronic pain, stiffness, and decreased mobility. Intra-articular injectable therapies show good clinical efficacy in improving symptoms; however, these therapies and their comparators (intra-articular saline) have been associated with a large underlying placebo effect. We aimed to describe the existing evidence on the challenges, hypotheses, and potential solutions to mitigate the intra-articular placebo effect in clinical trials in KOA. A targeted literature review was conducted by searching Embase, MEDLINE®, and CENTRAL using predefined study selection criteria. All eligible studies identified were extracted for relevant data, and results were narratively summarized. Forty-three studies were included following screening. Challenges associated with the intra-articular placebo effect included its ability to mask the comparative efficacy of active treatments in trials (n = 7 studies), long-lasting effects (up to 6 months; n = 3), and substantial variation of placebo effect sizes across populations (n = 3). Hypotheses for the mechanism of the placebo effect included aspiration of synovial fluid during administration (n = 6) and dilution of inflammatory mediators (n = 2). Factors affecting the placebo effect size were more invasive routes of administration (e.g., injection versus oral; n = 4) and patient expectations (n = 2). Proposed solutions included the suggestion for readers to weigh the relevance of clinical trial evidence against the presence of large underlying placebo effects (n = 9), discontinuation of intra-articular saline as an appropriate placebo (n = 5), and inclusion of 'no treatment' or sham injection as a control (n = 4). The intra-articular placebo effect is a well-documented occurrence in KOA clinical trials, and it is suggested that it be accounted for when designing randomized controlled trials. Awareness and understanding of the intra-articular placebo effect in KOA are required for fair interpretation of clinical trial evidence.

The successful migration of total joint arthroplasty from the hospital inpatient to outpatient ASC setting.

BACKGROUND: This study was undertaken to analyze the clinical results and complication rate of patients undergoing outpatient total joint arthroplasty by a single orthopedic group. All surgeries were performed in the practice-owned ambulatory surgery center (ASC). METHODS: All patients indicated for outpatient total joint arthroplasty from 2016-2019 with complete pre and post-operative patient reported outcomes were enrolled in the study including hip, knee and partial knee replacements. Patient reported outcomes including HOOS, KOOS and VR-12 were collected at six months. Patient complication and satisfaction data was also collected. RESULTS: There were 1007 patients enrolled in the study. At six months, THA HOOS and VR-12 scores improved to 82.2 and 54.5/45. TKA KOOS and VR-12 scores improved to an average of 74.3 and 54.0/43.6. At six months, UKA scores improved to an average of 73.6 and 55.1/41.2. All HOOS, KOOS and VR-12 PCS scores improvements were statistically significant (p < 0.001) and met MCID thresholds. A separate cohort of 1898 regionally tracked cases with comprehensive global complication data exhibited 111 complications (unplanned post-operative events generating a medical expense) including manipulation 13 (0.68%), DVT/PE 4 (0.2%), medical 45 (2.4%), wound 8 (0.4%), infection 8 (0.4%). Sixty-six outpatient cases (3.5%) experienced clinical complications requiring some form of additional treatment. CONCLUSION: Outpatient joint arthroplasty performed in the ASC is safe and effective in appropriately selected patients with complication rates that compares favorably to inpatient procedures.

Editorial Commentary: Denial of Payment Limits Patient Access to Musculoskeletal Procedures: What Can Willie Sutton Teach Us About the Decreasing Incidence of Acromioplasty?

Arthroscopic acromioplasty is one of the most commonly performed orthopedic surgical procedures. The indication for performing an acromioplasty has traditionally been based on the mechanical theory of impingement of the coracoacromial arch on the soft tissues of the rotator cuff footprint. Orthopedic surgeons have recommended surgically decompressing this phenomenon for six decades to eliminate shoulder pain and restore function. Recent high-level studies have cast doubt on the value of acromioplasty compared to other nonoperative treatment modalities. There is also an increased recognition and awareness that rotator cuff disease is as much a degenerative and senescent process as it is a mechanical one. There is now good evidence that the incidence of acromioplasty is falling significantly, especially in treatment scenarios that involve an intact rotator cuff. The cause of this decrease must be understood as multifactorial and related to both the clinical evidence and the economics and reimbursement policy concerning acromioplasty. Like many other high-volume and elective orthopedic surgical procedures, third-party reimbursement policy dictates patient access to treatments. Yet, current and future literature and clinical expertise determine proper indications for acromioplasty. Doctors are in the best position to indicate proper patient care.

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry.

PURPOSE: The purpose of this study was to prospectively collect safety and efficacy data in a large group of patients undergoing arthroscopic repair of full-thickness rotator cuff tears augmented with a resorbable bioinductive bovine collagen implant designed to promote healing. METHODS: Seventeen centers across the United States enrolled patients in an institutional review board-approved registry to collect outcomes data on the implant. Patients undergoing surgical management of full-thickness rotator cuff tears augmented with the implant were enrolled. Inclusion criteria were age of ≥21 years, willingness to participate and the ability to read and speak English. Exclusion criteria included hypersensitivity to bovine-derived products. Patients were assessed before and after surgery at up to 1 year with outcomes including the single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12) mental components and physical components (VR-12 PCS), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcome measures. Ad hoc analyses were performed to compare these outcomes at all time points depending on tear size (small/medium vs large/massive). Serious complications were collected. RESULTS: Of 210 patients enrolled, 192 had 1-year follow-up data available. The patients experienced statistically significant improvement between baseline and 1 year for mean SANE, VR-12 PCS, ASES, and WORC scores (40.0-82.0, 33.5-47.3, 46.2-87.8, and 36.2-81.0, respectively; P < .001 for all results). Ad-hoc analysis demonstrated that similar results were obtained at 1 year regardless of tear size. Twenty patients (10.4%) experienced serious complications (10.4%), including revision surgery (n = 18), proximal humerus fracture/partial subscapularis tear resulting from multiple falls (n = 1), and adhesive capsulitis (n = 1). CONCLUSIONS: The safety and efficacy of a bioinductive implant in the surgical management of full-thickness rotator cuff tears at 1 year was shown in this study. Implant efficacy appears to be comparable regardless of the underlying tear size. LEVEL OF EVIDENCE: Level IV, therapeutic case series.

Risk of Severe Acute Localized Reactions for Different Intraarticular Hyaluronic Acid Knee Injections in a Real-World Setting.

OBJECTIVE: Case reports of severe acute localized reactions (SALR) following intraarticular (IA) hyaluronic acid (HA) injections for knee osteoarthritis (OA) have been described. We compared surrogate SALR measures between patients using hylan G-F 20 and specific non-hylan G-F 20 HA products. DESIGN: Knee OA patients were identified from the Optum Clinformatics dataset (January 2006 to June 2016), stratified into hylan G-F 20 and non-hylan G-F 20 HA users, matched by single or multiple injection products. Occurrences of surrogate SALR measures including inflammation/infection, intraarticular corticosteroid (CS) injections, arthrocentesis/aspiration, arthrotomy/incision and drainage, and arthroscopy were evaluated within 3 days post-HA. RESULTS: Based on 694,404 HA injections, inflammation/infection rate was rare within 3 days of HA (up to 0.03%), with no statistical differences between hylan G-F 20 and non-hylan G-F 20 groups (matched by single or multiple injection products). The risk of knee arthrotomy/incision and drainage, arthroscopy, or arthrocentesis for hylan G-F 20 (2 mL) 3 weekly injection patients was lower than Hyalgan/Supartz and Orthovisc patients, but greater than Euflexxa patients. Overall, we found that Hylan G-F 20 (2 mL) 3 weekly injection had lower SALR rates compared to Hyalgan/Supartz and Orthovisc. However, Hylan G-F 20 (2 mL) 3 weekly injection had slightly higher rates of SALR when compared to Euflexxa. Among the single injection products, Hylan G-F 20 (6 mL) single injection had lower rates of SALR than Monovisc and Gel-One. CONCLUSIONS: This study shows no clear correlation between avian-derived or cross-linked products and SALR and provides evidence against avian-derived products or crosslinking as a source for these reactions.

Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry.

BACKGROUND: Surgical treatment of partial-thickness rotator cuff tears remains challenging and controversial, with several traditional options including debridement with acromioplasty, transtendon or in situ repair, and take-down and repair. A resorbable bioinductive bovine collagen implant has shown promise as an alternative treatment option for partial-thickness tears. PURPOSE: Data from a registry were analyzed to further establish that the implant contributes to improved patient-reported outcome (PRO) scores across a large number of patients treated for partial-thickness rotator cuff tears. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A total of 19 centers in the United States enrolled patients >21 years old with partial-thickness tears of the rotator cuff in a comprehensive prospective multicenter registry. PRO scores were recorded preoperatively and postoperatively at 2 and 6 weeks, 3 and 6 months, and 1 year: American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, Veterans RAND 12-Item Health Survey (physical and mental component scores), and Western Ontario Rotator Cuff scores. Revisions were reported throughout the study. RESULTS: The registry included 272 patients with partial-thickness tears (49 grade 1 tears, 101 grade 2 tears, and 122 grade 3 tears), 241 who underwent isolated bioinductive repair (IBR; collagen implant placed after bursectomy without a traditional rotator cuff repair), and 31 who had take-down and repair with bioinductive augmentation. Patients experienced statistically significant and sustained improvement from baseline for all PRO scores beginning at 3 months. Among patients with grade ≥2 tears, those with take-down and repair had significantly inferior scores at 2 and 6 weeks for most PRO scores as compared with those who underwent IBR, but the difference was no longer significant at 1 year for all but the physical component score of the Veterans RAND 12-Item Health Survey. There were 11 revisions, which occurred at a mean ± SD of 188.7 ± 88.0 days after the index surgery. There were no infections. CONCLUSION: This registry analysis further establishes across a large data set that this resorbable bioinductive bovine collagen implant improves PROs in all grades of partial-thickness tears, whether used as IBR or in conjunction with take-down and repair. IBR may offer improved early clinical outcomes (≤6 weeks) and comparable outcomes at 1 year when compared with a more invasive "take-down and repair" approach.

The Near-Term Ramifications of Long-Term Trends in Orthopedic Surgical Reimbursement.

BACKGROUND: There has been 25-year trend of decreasing value for orthopedic surgical work based on the Resource-Based Relative Value Scale (RBRVS) for Medicare reimbursement. This study was undertaken to estimate the time that Medicare payment rates for time spent in the office doing cognitive work will equal time dedicated in the operating room to performing procedural work based on long-term negative payment trends. METHODS: The RBRVS Update Committee database was accessed to extract the time elements for 2 procedures, total knee arthroplasty and total hip arthroplasty (27447 and 27130), on the day of surgery. The evaluation and management code mix for 2 mid-sized orthopedic practice was averaged to create an amalgamated rate for the reimbursement of office work on an hourly rate. A graph of the 25-year trend line in Medicare reimbursement for arthroplasty procedures was used to create a trend line. The trend line was then extrapolated to estimate the time in the future that the hourly rate for office work would equal the hourly rate for surgery. RESULTS: Time inputs and the Medicare conversion factor for 2021 were used in this analysis. Total procedural time for both 27447 and 27130 was 204 minutes (3.4 hours) on the day of surgery. An amalgamated hourly office rate of 7.9 relative value unit was calculated from the average of the 2 mid-sized private practices for an overall in office Medicare reimbursement of $318.89/h, with $1083.04 for the 3.4 hours allowed in the RBRVS Update Committee database for a joint replacement. When the trend line for reimbursement was extrapolated to the $1083.04 price point, the year corresponding to the point where hourly office reimbursement would equal hourly surgical work was 2024. CONCLUSION: Policymakers in Washington and practicing orthopedic surgeons need to consider the looming economic parity of surgical and cognitive work for Medicare. Continued negative reimbursement rates are likely to decrease patient access to necessary surgical care and result in de facto rationing of arthroplasty services for Medicare patients. The deployment of the orthopedic workforce is likely to change to accommodate the decreases in the value of surgical work. This trend will have significant impact on the practice of musculoskeletal medicine and patient access to orthopedic services.

Biologic Association Annual Summit: 2020 Report.

Interest and research in biologic approaches for tissue healing are exponentially growing for a variety of musculoskeletal conditions. The recent hype concerning musculoskeletal biological therapies (including viscosupplementation, platelet-rich plasma, and cellular therapies, or "stem cells") is driven by several factors, including demand by patients promising regenerative evidence supported by substantial basic and translational work, as well as commercial endeavors that complicate the scientific and lay understanding of biological therapy outcomes. While significant improvements have been made in the field, further basic and preclinical research and well-designed randomized clinical trials are needed to better elucidate the optimal indications, processing techniques, delivery, and outcome assessment. Furthermore, biologic treatments may have potential devastating complications when proper methods or techniques are ignored. For these reasons, an association comprising several scientific societies, named the Biologic Association (BA), was created to foster coordinated efforts and speak with a unified voice, advocating for the responsible use of biologics in the musculoskeletal environment in clinical practice, spearheading the development of standards for treatment and outcomes assessment, and reporting on the safety and efficacy of biologic interventions. This article will introduce the BA and its purpose, provide a summary of the 2020 first annual Biologic Association Summit, and outline the future strategic plan for the BA.

Coding Basics and Guidelines for Musculoskeletal Office Evaluation and Management.

¼ In documenting a patient encounter, the orthopaedic evaluation consists of 3 key components: "History," "Physical Examination," and "Medical Decision-Making." ¼ The level of service coded must be supported by the complexity of the problem, the care provided, and the documentation of the encounter. ¼ Determining whether the patient is new or established is the first step in the evaluation and management (E/M) process and relies on same-practice/same-specialty rules. ¼ Careful attention must be paid to documentation and coding to allow for appropriate care of the patient and efficient use of the orthopaedist's time. The available step-by-step guidelines include all necessary criteria to accomplish this. ¼ Continue to monitor for the U.S. Centers for Medicare & Medicaid Services (CMS) changes to stay up-to-date on changes in the guidelines.

Editorial Commentary: A Rigged Game-Surgeon Reimbursement Under the Resource-Based Relative Value Scale, Current Procedural Terminology, and the Affordable Care Act.

The value of surgeon procedural work is currently determined through a fee-setting process controlled by the Centers for Medicare & Medicaid Services. This process relies on the Resource-Based Relative Value Scale (RBRVS) to advise the Centers for Medicare & Medicaid Services concerning surgical work reimbursement. This system and several other government policy decisions over the past 25 years have placed orthopaedic surgeons at great disadvantage in establishing and maintaining the value of orthopaedic surgical work. Continued reliance on the RBRVS will result in further reductions in surgical reimbursements and may affect patient access to orthopaedic services. Orthopaedic surgeons must consider moving away from the RBRVS and Current Procedural Terminology as a way of determining value and instead establish price as the value signal in orthopaedic medicine. Bundled-payment methodologies offer one mechanism for establishing price in the marketplace.

Arthroscopic Rotator Cuff Repair Metrics: Establishing Face, Content, and Construct Validity in a Cadaveric Model.

PURPOSE: To create and determine face validity and content validity of arthroscopic rotator cuff repair (ARCR) performance metrics, to confirm construct validity of the metrics coupled with a cadaveric shoulder, and to establish a performance benchmark for the procedure on a cadaveric shoulder. METHODS: Five experienced arthroscopic shoulder surgeons created step, error, and sentinel error metrics for an ARCR. Fourteen shoulder arthroscopy faculty members from the Arthroscopy Association of North America formed the modified Delphi panel to assess face and content validity. Eight Arthroscopy Association of North America shoulder arthroscopy faculty members (experienced group) were compared with 9 postgraduate year 4 or 5 orthopaedic residents (novice group) in their ability to perform an ARCR. Instructions were given to perform a diagnostic arthroscopy and a 2-anchor, 4-simple suture repair of a 2-cm supraspinatus tear. The procedure was videotaped in its entirety and independently scored in blinded fashion by trained, paired reviewers. RESULTS: Delphi panel consensus for 42 steps and 66 potential errors was obtained. Overall performance assessment showed a mean inter-rater reliability of 0.93. Novice surgeons completed 17% fewer steps (32.1 vs 37.5, P = .001) and enacted 2.5 times more errors than the experienced group (6.21 vs 2.5, P = .012). Fifty percent of the experienced group members and none of the novice group members achieved the proficiency benchmark of a minimum of 37 steps completed with 3 or fewer errors. CONCLUSIONS: Face validity and content validity for the ARCR metrics, along with construct validity for the metrics and cadaveric shoulder, were verified. A proficiency benchmark was established based on the mean performance of an experienced group of arthroscopic shoulder surgeons. CLINICAL RELEVANCE: Validated procedural metrics combined with the use of a cadaveric shoulder can be used to accurately assess the performance of an ARCR.

Editorial Commentary: What You See Is What You Get-Is In-Office Needle Arthroscopy Ready for Prime Time?

In-office needle arthroscopy (IONA) has been around for many years, and technological improvements in image fidelity, patient convenience and access to care, and medical economics have resulted in renewed interest in this diagnostic tool. Patients could be well served by an immediate diagnosis of their joint pathology at the initial office encounter. A limitation of the current literature is that for research purposes, studies comparing IONA with diagnostic surgical arthroscopy and/or magnetic resonance imaging have been performed in the operating room-not the office setting. In addition, IONA is limited to intra-articular evaluation. IONA has been shown to be accurate and cost-effective, and future adoption of this modality seems promising.

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears.

PURPOSE: To collect outcomes data on patients treated with a bioinductive collagen implant designed to induce rotator cuff healing in partial- and full-thickness cuff tears and to assess the safety and efficacy of the device. METHODS: Fifteen surgeons in 15 centers in the United States enrolled patients between April 2016 and August 2017 and collected standardized outcomes data. Patients 21 years of age and older, able to read and speak English, and with partial- or full-thickness tears of the rotator cuff documented by magnetic resonance imaging were included in the study. Patients were assessed preoperatively with visual analogue scale (VAS), single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcomes measures. Postoperative assessment was made at 2, 6, and 12 weeks, 6 months, and 1 year. Patients underwent a standardized operative procedure with the implant. Patient demographics, comorbidities, tear types, and concomitant operative procedures were recorded. RESULTS: Patients in both groups experienced statistically significant improvement in VAS, SANE, VR-12 PCS, ASES, and WORC scores (mean values 1.1, P < .001; 86.0, P < .001; 49.7, P < .001; 85.6, P < .001; and 84.4, P < .001 for partial tears and 1.2, P < .001; 80.7, P < .001; 45.7, P < .001; 83.8, P < .0001; and 80.1, P < .001 for full-thickness tears, respectively). For the partial tear group, average times for return to driving, work, and nonoverhead athletic activity were 14.6, 37.3, and 65.6 days, and for the full-thickness group, 24.5, 50.7, and 119.2 days, respectively. In the partial-thickness group, 84% and 83% of patients reported improvement in their VAS pain and ASES scores, respectively, that met or exceeded each measure's minimal clinically important difference. In the full-thickness group, 72% and 77% of the patients met or exceeded the minimal clinically important differences for VAS pain and ASES, respectively. CONCLUSION: Outcomes after repair of partial- and full-thickness rotator cuff tears using a bioinductive implant show safety and efficacy at 1-year follow-up. LEVEL OF EVIDENCE: Retrospective case series, level IV evidence.

Cost-Effectiveness Analysis of Needle Arthroscopy Versus Magnetic Resonance Imaging in the Diagnosis and Treatment of Meniscal Tears of the Knee.

PURPOSE: To determine whether needle arthroscopy (NA) compared with magnetic resonance imaging (MRI) in the diagnosis and treatment of meniscal tears is cost-effective when evaluated over a 2-year period via patient-reported outcomes. The hypothesis is that improved diagnostic accuracy with NA would lead to less costly care and similar outcomes. METHODS: A Markov model/decision tree analysis was performed using TreeAge Pro 2017 software. Patients were evaluated for degenerative and traumatic damage to the lateral/medial meniscus. Assumed sensitivities and specificities were derived from the medical literature. The direct costs for care were derived from the 2017 Medicare fee schedule and from private payer reimbursement rates. Costs for care included procedures performed for false-positive findings and for care for false-negative findings. Effectiveness was examined using the global knee injury and osteoarthritis outcome score (KOOS). Patients were evaluated over 2 years for costs and outcomes, including complications. Dominance and incremental cost-effectiveness were evaluated, and 1- to 2-way sensitivity analysis was performed to determine those variables that had the greatest effect. The consolidated economics evaluation and reporting standards checklist for reporting economic evaluations was used. RESULTS: NA was less costly and had similar KOOS versus MRI for both the medial/lateral meniscus with private pay. Costs were less for both Medicare and private pay for medial meniscus, $780 to $1,862, and lateral meniscus, $314 to $1,256, respectively. CONCLUSIONS: Based on the reported MRI incidence of false positives with the medial meniscus and false negatives with the lateral meniscus and based on assumed standards of care, more costly care is provided when using MRI compared with NA. Outcomes were similar with NA compared with MRI. LEVEL OF EVIDENCE: Level II, economic and decision analysis.