Cryoneurolysis Associated with Improved Pain, Function, and Sleep in Patients Following Total Knee Arthroplasty: Use of a New Real-World Registry.

INTRODUCTION: Total knee arthroplasty (TKA) is performed on approximately 790,000 patients annually in the United States and is projected to increase to 1.5 million by 2050. This study aimed at assessing the use of preoperative cryoneurolysis on patients undergoing TKA by analyzing: 1) pain severity; 2) opioid use; 3) functional status; and 4) sleep disturbance over 6 months following discharge. METHODS: Patients enrolled in the Innovations in Genicular Outcomes Registry (iGOR) between September 2021 and February 2024 were followed for 6 months. Our analyses included patients undergoing unilateral primary TKA with no pre-operative opioid prescription who either received, or did not receive, cryoneurolysis. Baseline patient demographics were collected before TKA and tabulated. Pain management was assessed via the Brief Pain Inventory-Short Form (BPI-SF) instrument for pain severity. Sleep disturbance was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. Each outcome measure was assessed prior to TKA, weekly, and at monthly follow-up. Data was analyzed by a generalized linear mixed-effect regression model to compare cryoneurolysis versus control patients, with a P < 0.05 as significant. RESULTS: There were 80 patients who were treated with preoperative cryoneurolysis, while 60 control patients did not have treatment. Patients receiving cryoneurolysis experienced significantly lower pain severity and sleep disturbance over the 6-month follow-up than control patients (P = 0.046). Cryoneurolysis was also associated with a trend toward greater functional improvement that did not reach statistical significance (P = 0.061). Further, patients who underwent cryoneurolysis were 72% less likely than controls to take opioids over six months following discharge (P <0.001). CONCLUSIONS: Pre-operative cryoneurolysis therapy in opioid-naïve patients undergoing TKA is associated with improved pain, decreased opioid use, and improved sleep disturbance for 6 months postoperatively. Cryoneurolysis, a non-opioid pain relief modality administered pre-operatively, demonstrated substantial benefits in patients who underwent TKA.

Improved Pain and Function with Triamcinolone Acetonide Extended-Release and Cryoneurolysis for Knee Osteoarthritis: Use of a New Real-World Registry.

INTRODUCTION: Knee osteoarthritis (OA) affects 19% of American adults over 45 years old and costs $27+ billion annually. A wide range of non-operative treatment options are available. This study compared six treatments: cryoneurolysis with deep genicular nerve block (Cryo-Deep/Both), cryoneurolysis with superficial nerve block (Cryo-Superficial), intra-articular hyaluronic acid (IA-HA) injections, non-steroidal anti-inflammatory drug injections (IA-NSAIDs), IA-corticosteroids (IA-CS) injections, or IA-triamcinolone extended release (IA-TA-ER) injections over 4 months for: 1) pain severity and analgesic use; and 2) physical function (from Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)). METHODS: Patients who had unilateral knee OA and received non-operative intervention were enrolled in the Innovations in Genicular Outcomes (iGOR) registry, a novel, multi-center real-world registry, between September 2021 and February 2024. A total of 480 patients were enrolled. Both pain and functional outcomes were assessed at baseline, weekly, and monthly, which were analyzed by: overall trend, magnitude changes pre- to post-treatment, and distribution-based minimal clinically important difference score (MCID). Multivariate linear regressions with adjustments for seven confounding factors were used to compare follow-up outcomes among six treatment groups. RESULTS: Use of IA-TA-ER injections was associated with the lowest pain, greatest pain reduction, and highest prevalence of patients achieving MCID relative to other treatments (P < 0.001). Deep/Both-Cryo and IA-CS were associated with a higher prevalence of achieving MCID than IA-HA, IA-NSAIDs, and Cryo-Superficial (P ≤ 0.001). Use of IA-TA-ER was also associated with the greatest functional score, improvement from baseline, and highest prevalence of patients achieving MCID than other treatments (P ≤ 0.003). CONCLUSIONS: The IA-TA-ER appears to outperform other treatments in terms of pain relief and functional improvement for up to 4 months following treatment. In addition, outcomes in the novel cryoneurolysis and conventional IA-CS were similar to one another and better than those in IA-HA and IA-NSAIDs.

A 5-Year Retrospective, Observational Study Assessing Rheumatoid Arthritis Disease Outcome Measures to Characterize Systemic Lupus Erythematosus Burden in the USA.

INTRODUCTION: We evaluated the use of rheumatoid arthritis (RA) disease measures in patients with systemic lupus erythematosus (SLE) in a US community-based rheumatology physician network over 5 years. METHODS: This retrospective, observational cohort study (GSK Study 213818) of patients with SLE utilized electronic medical records (01 January 2010-31 December 2019) from the United Rheumatology Normalized Integrated Community Evidence database. The index was the date of first SLE diagnosis recorded in the database; the observation period was 5 years post-index. RA disease measures evaluated were: Pain Index, Multi-Dimensional Health Assessment Questionnaire (MD-HAQ), Patient Global Assessment (PtGA), Physician Global Assessment (PGA), Swollen Joint Count (SJC), Tender Joint Count (TJC), Routine Assessment of Patient Index Data 3 (RAPID3), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and Disease Activity Score 28 (DAS-28). The number of patients with measures utilized, the score on each measure, and proportion of patients per disease activity category were assessed. RESULTS: Overall, 5990 patients with SLE were included. The most frequently used measures were Pain Index, SJC, TJC, MD-HAQ, PtGA, RAPID3, and PGA (cumulative use over Years 1-5: 23.9-71.3%). For all measures, frequency of use was lowest in Year 1, followed by a general increase from Year 1 to Year 5. Scores remained relatively stable for most measures, and the proportion of patients in remission or with low/moderate disease activity per RAPID3 increased. CONCLUSION: RA disease measure utilization in SLE was generally infrequent but increased over time. Pain Index and MD-HAQ were the most commonly applied cumulatively across 5 years of follow-up. The rationale for the increased use of these measures in SLE over time requires further exploration. In the absence of a clinically applicable SLE-specific measure, the use of RA measures, for example in conjunction with SLE measures, may provide an alternative approach for measuring disease activity, representing an opportunity to improve patient outcomes.

Knee Osteoarthritis Treatment Costs in the Medicare Patient Population.

BACKGROUND: Several nonoperative options have been recommended for the treatment of knee osteoarthritis (OA), with varying degrees of evidence. Adhering to the American Academy of Orthopaedic Surgeons clinical practice guidelines has been suggested to decrease direct treatment costs by 45% in the year before knee arthroplasty, but this does not consider the cost of the entire episode of care, including the cost of surgery and postsurgery care. OBJECTIVES: To analyze the total treatment costs after a diagnosis of knee OA, as well as the proportion of arthroplasty interventions as part of the total knee OA-related costs, and whether the total costs differed for patients who received intra-articular hyaluronic acid and/or had knee arthroplasty. METHODS: We identified patients newly diagnosed with knee OA using the 5% Medicare data sample from January 2010 to December 2015. Patients were excluded if they were aged <65 years, had incomplete claim history, did not reside in any of the 50 states, had claim history <12 months before knee OA diagnosis, or did not enroll in Medicare Part A and Part B. The study analyzed knee OA-related costs from a payer perspective in terms of reimbursements provided by Medicare, as well as the time from the diagnosis of knee OA to knee arthroplasty for patients who had knee arthroplasty, and the time from the first hyaluronic acid injection to knee arthroplasty for those who received the injection. We compared patients who received hyaluronic acid and those who did not receive hyaluronic acid injections. Patients who received hyaluronic acid injection who subsequently had knee arthroplasty were also compared with those who did not have subsequent knee arthroplasty. RESULTS: Of the 275,256 patients with knee OA, 45,801 (16.6%) received a hyaluronic acid injection and 35,465 (12.9%) had knee arthroplasty during the study period. The median time to knee arthroplasty was 16.4 months for patients who received hyaluronic acid versus 5.7 months for those who did not receive hyaluronic acid. Non-arthroplasty-related therapies and knee arthroplasty accounted for similar proportions of knee OA-related costs, with hyaluronic acid injection comprising 5.6% of the total knee OA-related costs. For patients who received hyaluronic acid injections and subsequently had knee arthroplasty, hyaluronic acid injection contributed 1.8% of the knee OA-related costs versus 76.6% of the cost from knee arthroplasty. Patients who received hyaluronic acid injections and did not have knee arthroplasty incurred less than 10% of the knee OA-related costs that patients who had surgery incurred. CONCLUSION: Although limiting hyaluronic acid use may reduce the knee OA-related costs, in this study hyaluronic acid injection only comprised a small fraction of the overall costs related to knee OA. Among patients who had knee arthroplasty, those who received treatment with hyaluronic acid had surgery delayed by a median of 10.7 months and associated costs for a significant period. The ability to delay or avoid knee arthroplasty altogether can have a substantial impact on healthcare costs.

AMSSM scientific statement concerning viscosupplementation injections for knee osteoarthritis: importance for individual patient outcomes.

Osteoarthritis (OA) is a disabling disease that produces severe morbidity reducing physical activity. Our position statement on treatment of knee OA with viscosupplementation injection (hyaluronic acid, HA) versus steroid (intra-articular corticosteroids, IAS) and placebo (intra-articular placebo, IAP) is based on the evaluation of treatment effect by examining the number of participants within a treatment arm who met the Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) criteria, which is different and more relevant than methods used in other reviews which examined if the average change across the treatment groups were clinically different. We performed a systematic literature search for all relevant articles from 1960 to August 2014 in the MEDLINE, EMBASE and Cochrane CENTRAL. We performed a network meta-analysis (NMA) of the relevant literature to determine if there is a benefit from HA as compared with IAS and IAP. 11 papers met the inclusion criteria from the search strategy. On NMA, those participants receiving HA were 15% and 11% more likely to respond to treatment by OMERACT-OARSI criteria than those receiving IAS or IAP, respectively (p<0.05 for both). In the light of the aforementioned results of our NMA, the American Medical Society for Sport Medicine recommends the use of HA for the appropriate patients with knee OA.

AMSSM Scientific Statement Concerning Viscosupplementation Injections for Knee Osteoarthritis: Importance for Individual Patient Outcomes.

OBJECTIVE: Osteoarthritis (OA) is a disabling disease that produces severe morbidity reducing physical activity. Our position statement on treatment of knee OA with viscosupplementation injection [hyaluronic acid (HA)] versus steroid [intra-articular corticosteroid (IAS)] and placebo [intra-articular placebo (IAP)] is based on the evaluation of treatment effect by examining the number of subjects within a treatment arm that met the Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) criteria, which is different and more relevant than methods used in other reviews which examined if the average change across the treatment groups was clinically different. DATA SOURCES: We performed a systematic literature search for all relevant articles from 1960 to August 2014 in the MEDLINE, EMBASE, and Cochrane CENTRAL. We performed a network meta-analysis (NMA) of the relevant literature to determine if there is a benefit from HA as compared with IAS and IAP. MAIN RESULTS: Eleven articles met the inclusion criteria from the search strategy. On NMA, those subjects receiving HA were 15% and 11% more likely to respond to treatment by the OMERACT-OARSI criteria than those receiving IAS or IAP, respectively (P < 0.05 for both). CONCLUSIONS: In light of the aforementioned results of our NMA, the American Medical Society for Sport Medicine recommends the use of HA for the appropriate patients with knee OA.

American Medical Society for Sports Medicine (AMSSM) position statement: interventional musculoskeletal ultrasound in sports medicine.

The use of diagnostic and interventional ultrasound has significantly increased over the past decade. A majority of the increased utilization is by nonradiologists. In sports medicine, ultrasound is often used to guide interventions such as aspirations, diagnostic or therapeutic injections, tenotomies, releases, and hydrodissections. This American Medical Society for Sports Medicine (AMSSM) position statement critically reviews the literature and evaluates the accuracy, efficacy, and cost-effectiveness of ultrasound-guided injections in major, intermediate, and small joints, and soft tissues, all of which are commonly performed in sports medicine. New ultrasound-guided procedures and future trends are also briefly discussed. Based upon the evidence, the official AMSSM position relevant to each subject is made.

American Medical Society for Sports Medicine (AMSSM) position statement: interventional musculoskeletal ultrasound in sports medicine.

BACKGROUND: The use of diagnostic and interventional ultrasound has significantly increased over the past decade. A majority of the increased utilisation is by non-radiologists. In sports medicine, ultrasound is often used to guide interventions such as aspirations, diagnostic or therapeutic injections, tenotomies, releases and hydrodissections. OBJECTIVE: Critically review the literature related to the accuracy, efficacy and cost-effectiveness of ultrasound-guided injections (USGIs) in major, intermediate and small joints; and soft tissues. DESIGN: Systematic review of the literature. RESULTS: USGIs are more accurate than landmark-guided injections (LMGIs; strength of recommendation taxonomy (SORT) Evidence Rating=A). USGIs are more efficacious than LMGIs (SORT Evidence Rating=B). USGIs are more cost-effective than LMGIs (SORT Evidence Rating=B). Ultrasound guidance is required to perform many new procedures (SORT Evidence Rating=C). CONCLUSIONS: The findings of this position statement indicate there is strong evidence that USGIs are more accurate than LMGI, moderate evidence that they are more efficacious and preliminary evidence that they are more cost-effective. Furthermore, ultrasound-guided (USG) is required to perform many new, advanced procedures and will likely enable the development of innovative USG surgical techniques in the future.

American Medical Society for Sports Medicine position statement: interventional musculoskeletal ultrasound in sports medicine.

The use of diagnostic and interventional ultrasound has significantly increased over the past decade. A majority of the increased utilization is by nonradiologists. In sports medicine, ultrasound is often used to guide interventions such as aspirations, diagnostic or therapeutic injections, tenotomies, releases, and hydrodissections. This American Medical Society for Sports Medicine (AMSSM) position statement critically reviews the literature and evaluates the accuracy, efficacy, and cost-effectiveness of ultrasound-guided injections in major, intermediate, and small joints, and soft tissues, all of which are commonly performed in sports medicine. New ultrasound-guided procedures and future trends are also briefly discussed. Based on the evidence, the official AMSSM position relevant to each subject is made.

Validation of American College of Rheumatology classification criteria for knee osteoarthritis using arthroscopically defined cartilage damage scores.

OBJECTIVE: To validate the ability of the American College of Rheumatology (ACR) clinical classification criteria and the ACR clinical plus radiographic classification criteria for osteoarthritis of the knee to predict articular cartilage damage. METHODS: Ninety subjects with knee osteoarthritis (OA) who were enrolled in a prospective study determining the therapeutic efficacy of arthroscopic irrigation were characterized as to whether they fulfilled the ACR clinical classification criteria or the ACR clinical plus radiographic classification criteria. Ten rheumatoid arthritis (RA) patients were included as controls. Cartilage damage was defined using the ACR/Knee Arthroscopy Osteoarthritis Scale (ACR/KAOS) system, which is a validated outcome instrument for knee OA based on arthroscopic visualization. Mean values of the damage scores in each group were calculated and compared by t-test to determine statistical significance between the 3 groups. RESULTS: The mean ACR/KAOS score for the 10 RA patients was 1.8 [SD 1.22; range 0 to 4]. Of the 90 OA patients who underwent arthroscopy, only 73 patients had sufficient videotape to make an accurate assessment by the blinded assessor. The mean ACR/KAOS score for the 6 OA patients who fulfilled only the ACR clinical classification was 17.4 [SD 11.3; range 5 to 34.3] and the mean ACR/KAOS score for the 67 patients who fulfilled the ACR clinical plus radiographic classification criteria was 42.0 [SD 29.1; range 5.1 to 118.4]. These differences were statistically significant (RA versus OA clinical P=0.02; RA versus OA clinical+radiographic P