Anterior Knee Pain (AKP) is a common condition that can be challenging to treat effectively. The main goal of treatment regimens is to improve the function of the knee. However, treatment can be challenging due to the knee pain experience. Cingal™ contains hyaluronic acid (HA), which acts as a joint lubricant, and the corticosteroid triamcinolone hexacetonide (TH). Some studies have shown that Cingal™ can improve joint function and provide short-term pain relief.

开始日期2026-04-01

申办/合作机构

Banff Sport Medicine Foundation

NCT04640298

/ CompletedN/A

A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (CINGAL®) to Provide Symptomatic Relief of Osteoarthritis of Hip Joint

This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal used for the symptomatic relief of osteoarthritis in the hip joint.

开始日期2021-01-16

申办/合作机构

Anika Therapeutics, Inc.

NCT04640961

/ CompletedN/A

A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (CINGAL®) to Provide Symptomatic Relief of Osteoarthritis of Shoulder Joint

This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal used for the symptomatic relief of osteoarthritis in the shoulder joint.

开始日期2021-01-16

申办/合作机构

Anika Therapeutics, Inc.

100 项与己曲安奈德/透明质酸钠相关的临床结果

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100 项与己曲安奈德/透明质酸钠相关的转化医学

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100 项与己曲安奈德/透明质酸钠相关的专利（医药）

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项与己曲安奈德/透明质酸钠相关的文献（医药）

2025-02-01·Journal of ISAKOS Joint Disorders & Orthopaedic Sports Medicine

Intra-articular injection of a cross-linked hyaluronic acid combined with triamcinolone hexacetonide improves pain at six months in patients with mild to moderate hip osteoarthritis: A prospective observational study

Article

作者: Dessouki, Shariff ; Lautenbach, Justin ; Williams, Ryan ; Rabinovich, Alexander ; Duong, Andrew ; Dalziel, Katie ; Hitchon, Maggie ; Maida, Eugene ; Kapuvari, Stephen ; Bourgeault-Gagnon, Yoan ; de SA, Darren ; Ayeni, Olufemi R. ; Heels-Ansdell, Diane ; Simunovic, Nicole ; Sim, Yan

OBJECTIVES:

Joint-preserving interventions, such as intra-articular viscosupplementation injections, are evolving and requiring efficacy and safety evaluations through an evidence-based approach. The objective of this study was to assess the use of a hyaluronic acid and corticosteroid-based injection (Cingal™; Anika Therapeutics, Bedford, MA, USA) in improving pain and functional outcomes for patients aged between 40 and 65 with mild to moderate hip osteoarthritis (OA) six months post-injection.

METHODS:

This prospective observational study included 100 patients receiving a single ultrasound-guided intra-articular injection of Cingal™. Eligible patients seen in participating orthopaedic, physiatry and sports medicine clinics were evaluated at baseline, one-month, and six-month follow-up. The primary outcome was patient-reported hip pain (Visual Analogue Scale, VAS) at six months post-injection. Secondary outcomes included hip function (Hip Disability and Osteoarthritis Outcome Score, HOOS), quality of life (Short-Form 12, SF-12), pain medication use, range of motion (ROM), physical activity (activity tracker), and adverse events.

RESULTS:

Ninety-six patients received the injection; 91 had complete data for primary outcome analysis. Statistically significant improvements were observed in VAS (p < 0.001), HOOS (p < 0.001), and SF-12 scores (Physical Component Summary, p = 0.005; Mental Component Summary, p = 0.022) from baseline to six months post-injection. Pain medication use decreased from 50.0% to 34.0% (p = 0.035). No statistically significant change was observed in ROM or activity level. Adverse events were reported in 9.5% of patients: five (5.3%) experienced hip pain for less than seven days, one for more than seven days but less than one month, and three (3.2%) underwent hip arthroplasty.

CONCLUSION:

Patients receiving an ultrasound-guided Cingal™ injection for hip OA reported statistically significantly reduced hip pain, improved function and quality of life, and reduced pain medication use at six months. The most common adverse event was transient hip pain.

LEVEL OF EVIDENCE:

Prospective observational study, Level III.

2018-07-01·Cartilage3区 · 医学

Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial

3区 · 医学

Article

作者: Vasarhelyi, Gabor ; Stevens, Gary ; Zgadzaj, Wojciech ; Hangody, György ; Dokoupilova, Eva ; Lukasik, Piotr ; Szody, Robert ; Lénárt, Endre ; Ficzere, Andrea ; Szendroi, Miklos ; Bichovsk, Daniela ; Hangody, Laszlo ; Berta, Agnes

Objective::

To evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis.

Design::

This multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The primary efficacy outcome was change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Score through 12 weeks with Cingal versus saline. Secondary outcomes included Patient and Evaluator Global Assessments, OMERACT-OARSI Responder index, and WOMAC Total, Stiffness, and Physical Function scores through 26 weeks.

Results::

A total of 368 patients were treated (Cingal, n = 149; Monovisc, n = 150; saline, n = 69). Cingal improvement from baseline was significantly greater than saline through 12 weeks ( P = 0.0099) and 26 weeks ( P = 0.0072). WOMAC Pain was reduced by 70% at 12 weeks and by 72% at 26 weeks with Cingal. Significant improvements were found in most secondary endpoints for pain and function at most time points through 26 weeks. At 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints; Cingal and Monovisc were similar from 6 weeks through 26 weeks. A low incidence of related adverse events was reported.

Conclusions::

Cingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline. Cingal had similar immediate advantages compared with HA alone, while showing benefit comparable to HA at 6 weeks and beyond.

2008-01-01·AJNR. American journal of neuroradiology2区 · 医学

Evaluation of a Neck-Bridge Device to Assist Endovascular Treatment of Wide-Neck Aneurysms of the Anterior Circulation

2区 · 医学

Article

作者: K. De Keukeleire ; P. Vanlangenhove ; L. Defreyne

BACKGROUND AND PURPOSE:

Intracranial aneurysms with a wide-neck or an unfavorable dome-to-neck ratio may be difficult to treat properly and safely. Our aim was to evaluate the TriSpan neck-bridge device to assist coiling of wide-neck bifurcation aneurysms in the anterior circulation.

MATERIALS AND METHODS:

In 14 patients, we performed 16 TriSpan-assisted coil embolizations with wide-neck bifurcation aneurysms of the anterior circulation. Eleven procedures were indicated for acutely ruptured aneurysms. Five were performed electively for the following: recurrent aneurysm after coil only (n = 1) or after TriSpan-assisted embolization (n = 2), aneurysm remnant after clipping (n = 1), and aneurysm incidentally found (n = 1). Procedural and clinical complications were recorded. Follow-up angiography was performed, and clinical outcomes were assessed by using the modified Rankin Scale score.

RESULTS:

TriSpan-assisted embolization was successful in 15/16 (93.8%) procedures, with complete occlusion in 2/16 (12.5%), near-complete occlusion in 10/16 (62.5%), and incomplete occlusion in 3/16 (18.75%). There were 6 (37.5%) intraprocedural complications: thrombus formation (n = 3), protrusion of a TriSpan loop in the parent artery (n = 1), TriSpan displacement in the aneurysm (n = 1), and tangling of a coil loop in the device (n = 1). Three patients died in the hospital (21.4%). Follow-up angiography or MR angiography was available in 8 (57.1%) patients and showed complete (n = 2), near-complete (n = 2), and incomplete occlusion (n = 4). Long-term clinical outcome was no (n = 4) or minor symptoms (n = 1) and moderate (n = 2), moderately severe (n = 2), or severe handicap (n = 2).

CONCLUSION:

The use of the TriSpan device is feasible in the anterior circulation and can assist treatment of difficult wide-neck bifurcation aneurysms.

项与己曲安奈德/透明质酸钠相关的新闻（医药）

2019-01-16

·BioSpace

Anika Announces Plans to Showcase HYALOFAST at the International Cartilage Regeneration and Joint Preservation Society (ICRS) Summit in San Diego

Jan. 16, 2019 21:05 UTC BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today announced plans to showcase HYALOFAST, a biodegradable, HA-based cartilage repair scaffold, at the 2019 International Cartilage Repair Society (ICRS) Summit. The 2019 ICRS Summit, which will be focused on Bio-Orthopaedics in Sports Medicine, will be held in San Diego, CA at the Hyatt Regency Mission Bay on January 17-18, 2019. At the 2019 ICRS Summit, Dr. Alberto Gobbi, world-renowned specialist in arthroscopic surgery, cartilage repair and regenerative medicine, will present findings from a 10-year follow-up study of patients treated with HYALOFAST HA scaffold with Bone Marrow Aspirate Concentrate (BMAC) in a one-step surgery. The session will also provide a comparative review of HYALOFAST in comparison to ACI (Autologous Chondrocyte Implantation) and MACI (Matrix Autologous Chondrocyte Implantation), two-step surgeries requiring cell cultivation. “The ICRS Summit in San Diego is a great opportunity to showcase the significant advantages of HYALOFAST before an assembly of world-renowned specialists in the field of cartilage repair and regeneration,” said Joseph Darling, President and CEO, Anika Therapeutics. “We believe that HYALOFAST is a truly remarkable advancement in the treatment of cartilage injuries and defects due to its flexible, minimally-invasive means of application and adaptive fit to individual patient needs.” HYALOFAST is a non-woven, single-step, off-the-shelf, biodegradable HA-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in approximately 15 countries and has been used to successfully treat more than 15,000 patients internationally, with strong ten-year patient follow-up data. HYALOFAST is pending regulatory submission in the United States following its FastTRACK Phase III trial which is currently enrolling patients across the U.S. and Europe. Technical Session 3: Cartilage Title: “One or Two Steps: Long Term Results” Presenter: Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy Date/Time: January 17, 2019 at 10:45 – 11:40am Company-Sponsored Booth Anika will be a Gold Sponsor and will host a booth (#6), where it will showcase HYALOFAST. About ICRS The ICRS (International Cartilage Regeneration and Joint Preservation Society) is the main forum for international collaboration in cartilaginous tissue research that brings together basic scientists, clinical researchers, physicians and members of industry, engaged or interested in the field of articular biology, its genetic basis and regenerative medicine. It provides continuing education and training to physicians and scientists with an active interest in the prevention and treatment of joint disease to improve patient care through regenerative medicine approaches. 2018 HYALOFAST Publications Gobbi A., et al. Use of bone marrow aspirate concentrate combined with hyaluronan-based scaffold for early osteoarthritis in athletes. Football Medicine Outcomes Abstract book XXVII Isokinetic Medical Group International Conference – Camp Nou, Barcelona 2-4 June 2018. Ed Calzetti & Mariucci. Page 442. Sofu H. et al. Clinical and radiographic outcomes of chitosan-glycerol phosphate/blood implant are similar with hyaluronic acid-based cell-free scaffold in the treatment of focal osteochondral lesions of the knee joint. Knee Surg Sports Traumatol Arthrosc. 2018 Aug 1. (Epub ahead of print). Gollwitzer H. Operative Therapie - Knorpelschäden der Hϋfte Einzeitiges arthroskopisches Verfahren zur Regeneration. Sportärztezeitung 03/2018 (Cartilage Damage to the Hip. One-Stage Arthroscopic Method of Regeneration). About Anika Therapeutics, Inc. Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit .

2018-06-20

·BioSpace

Anika Craters Following Failure of Phase III Knee Osteoarthritis Study

Red trend as symbol of business recession and financial crisis. Large resolution Arsgera/Getty Images/iStockphoto Shares of Bedford, Mass.-based Anika Therapeutics have plunged more than 20 percent in premarket trading. Shares of Bedford, Mass.-based Anika Therapeutics have plunged more than 20 percent in premarket trading after the company announced its Phase III knee osteoarthritis study failed to meet endpoints. Anika said its CINGAL product for knee osteoarthritis did not achieve statistical significance at primary endpoint of 26 weeks in active comparator study. While CINGAL, a combination of cross-linked hyaluronic acid (HA) and triamcinolone hexacetonide (TH), achieved greater pain reduction numerically at every time point in the study, the difference at 26-weeks did not reach statistical significance when compared with triamcinolone hexacetonide alone, the company said late Tuesday. The duration of pain reduction was also similar to the previous study as patient improvement after CINGAL injection was maintained near peak levels throughout the 26-week duration of the study. In a previous placebo-controlled 13-01 Phase III trial, Anika said CINGAL demonstrated safety and efficacy through 26 weeks. With the efficacy demonstrated in the previous Phase III trial and the other data from the 16-02 trial that did not achieve statistical significance, Anika plans to work closely with regulators at the U.S. Food and Drug Administration (FDA) to gain approval. The patient response to CINGAL throughout the study was strong, the company said. Anika noted that patients saw significant improvements in pain, function, and quality of life were observed at levels consistent with, and in most cases greater than, the results of the 13-01 placebo-controlled Phase III study of CINGAL. The company does intend to complete a three-month follow-up extension phase of the study will continue. Cingal has been approved for use outside the United States. Joseph Darling, president and chief executive officer of Anika, said osteoarthritis patients who use approved Cingal in other markets continue to benefit from the proven safety and efficacy of CINGAL.” Darling noted that the benefits of combining hyaluronic acid and a corticosteroid have been expressed through physician feedback and “real-world experience.” “While we expected CINGAL to perform as well as it did, we were surprised that the difference in pain reduction seen in this trial did not reach statistically significant levels at six months. We will, however, continue to monitor the results of the ongoing three-month extension study,” Darling said in a statement. “We are actively reviewing the data and our plan is to work closely with regulators to come to an understanding of the next steps required to gain U.S. regulatory approval of CINGAL. We remain fully committed to bringing this impactful OA solution to U.S. patients and physicians.” Lazlo Hangody, the global principal investigator of multiple CINGAL trials, concurred with Darling about the overall efficacy of CINGAL. Despite the failure of statistical significance in comparison to triamcinolone hexacetonide alone, Hangody said the patient response to CINGAL was strong. Patients “received statistically and clinically meaningful rapid and long-lasting improvement in symptoms compared with base-line,” Hangody said. That relief was consistent with the previous study. “Taken together, the results of the two Phase III studies validate the effectiveness of this novel combination for use in patients with knee osteoarthritis,” Hangody said.

临床3期临床结果上市批准

100 项与己曲安奈德/透明质酸钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	H02AB08	-

研发状态

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适应症	国家/地区	公司	日期
骨关节炎	加拿大	Anika Therapeutics, Inc.	2015-11-03

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适应症	最高研发状态	国家/地区	公司	日期
膝关节炎	临床3期	捷克	Anika Therapeutics, Inc.	2015-02-01
膝关节炎	临床3期	匈牙利	Anika Therapeutics, Inc.	2015-02-01
膝关节炎	临床3期	波兰	Anika Therapeutics, Inc.	2015-02-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04231318 (CTgov)	临床3期	膝关节炎	231	Cingal (Cingal)	繭構蓋鑰鑰觸醖構範獵(夢構齋選窪築膚願鬱鏇) = 鹹觸餘願範繭願醖壓鏇鹽醖醖餘膚蓋淵衊積鑰 (鬱蓋製鑰廠窪廠廠繭窪, 21.6) 更多	-	2023-08-09
				Triamcinolone Hexacetonide (Triamcinolone Hexacetonide (TH))	繭構蓋鑰鑰觸醖構範獵(夢構齋選窪築膚願鬱鏇) = 鹹範積鏇淵壓獵壓網膚鹽醖醖餘膚蓋淵衊積鑰 (鬱蓋製鑰廠窪廠廠繭窪, 22.9) 更多
NCT03390036 (Cingal17-02, CTgov)	临床3期	膝关节炎	526	Cingal (Cingal)	衊醖獵構鏇簾膚壓鬱繭 = 觸繭餘鏇鹽鏇窪簾顧襯獵蓋淵鏇蓋憲構壓鏇鹽 (憲鑰製構糧繭廠餘製鹹, 範觸築蓋淵鑰鏇夢鏇鑰 ~ 膚鑰簾製廠網膚襯廠鏇) 更多	-	2023-05-31
				Monovisc (Monovisc)	衊醖獵構鏇簾膚壓鬱繭 = 觸鹹鹹衊艱構願衊壓鹹獵蓋淵鏇蓋憲構壓鏇鹽 (憲鑰製構糧繭廠餘製鹹, 鑰繭窪獵憲夢醖糧憲鬱 ~ 繭糧積觸夢觸鑰選艱淵) 更多
NCT03191903 (CTgov)	临床3期	膝关节炎	576	Cingal (Cingal)	簾齋膚顧鬱鏇醖選窪齋(積鹽遞積積鏇窪憲壓繭) = 夢鏇遞壓願範簾鬱積製壓簾簾築膚觸鹹範構夢 (築鑰衊艱鑰積艱鏇築壓, 19.9) 更多	-	2022-02-24
				Monovisc (Monovisc)	簾齋膚顧鬱鏇醖選窪齋(積鹽遞積積鏇窪憲壓繭) = 觸積鬱鹽構膚繭蓋鬱夢壓簾簾築膚觸鹹範構夢 (築鑰衊艱鑰積艱鏇築壓, 19.1) 更多
NCT02381652 (CTgov)	临床3期	膝关节炎	242	Cingal (Cingal/Cingal)	鹽壓夢鹹範鏇顧築顧繭(鹽襯網構獵窪製鹽鑰艱) = 膚壓範願醖壓積窪積遞簾蓋選鹽淵積壓窪築膚 (製範鹽網築淵襯選築夢, 鑰選遞淵構觸壓鑰製顧 ~ 衊夢蓋築鹹鏇鏇簾鹽繭) 更多	-	2020-09-03
				Cingal (Cingal/Monovisc)	鹽壓夢鹹範鏇顧築顧繭(鹽襯網構獵窪製鹽鑰艱) = 艱獵壓鑰壓蓋壓壓憲糧簾蓋選鹽淵積壓窪築膚 (製範鹽網築淵襯選築夢, 遞願選遞壓淵鹹糧齋衊 ~ 襯鬱窪構簾壓廠鏇醖醖) 更多