A double-blind, randomized, saline-controlled study of the efficacy and safety of co-administered intra-articular injections of Tr14 and Ze14 for treatment of painful osteoarthritis of the knee: The MOZArT trial

Lozada, Carlos J.; Rio, Eve Del; Reitberg, Donald P.; Smith, Robert A.; Kahn, Charles B.; Moskowitz, Roland W.

doi:10.1016/j.eujim.2017.07.005

Cited by 17 publications

(11 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…As such, promising therapeutic candidates that are currently in early-clinical or preclinical development, such as RCGD 423 136 and UBX0 101 137,138 , are not discussed. Treatments for which clinical data has been published, but for which there are no current plans for further development, such as co-injected Tr14 (Traumeel) and Ze14 (Zeel) 139 have also been excluded from this Review.…”

Section: The Intra-articular Therapy Pipelinementioning

confidence: 99%

Intra-articular treatment options for knee osteoarthritis

et al. 2018

View full text Add to dashboard Cite

Intra-articular drug delivery has a number of advantages over systemic administration; however, for the past 20 years, intra-articular treatment options for the management of knee osteoarthritis (OA) have been limited to analgesics, glucocorticoids, hyaluronic acid (HA) and a small number of unproven alternative therapies. Although HA and glucocorticoids can provide clinically meaningful benefits to an appreciable number of patients, emerging evidence indicates that the apparent effectiveness of these treatments is largely a result of other factors, including the placebo effect. Biologic drugs that target inflammatory processes are used to manage rheumatoid arthritis, but have failed to translate to OA. A lack of high-level evidence and methodological limitations hinder our understanding of so called ‘stem’ cell therapies and, although the off-label administration of intra-articular cell therapies (such as platelet-rich plasma and bone marrow aspirate concentrate) is common, high-quality clinical data is needed before these treatments can be recommended. A number of promising intra-articular treatments are currently in clinical development in the United States, including small-molecule and biologic therapies, devices, and gene therapies. Although the prospect of new, non-surgical treatments for OA is exciting, the benefits new treatments must be carefully weighed against their costs and potential risks.

show abstract

Section: The Intra-articular Therapy Pipelinementioning

confidence: 99%

Intra-articular treatment options for knee osteoarthritis

et al. 2018

View full text Add to dashboard Cite

show abstract

“…Results: From 20 patients (age 49±6 yrs), two withdrew informed consent and three other patients were treated with TKP (after three and four years), so the survival of the knee joint was 80% at 5 years. Moreover, there was persistent clinical improvement compared to baseline sustaining over time: WOMAC +21, 1 points (CI:8,3;p=0.002),0;p<0.001). In addition, minimum radiographic JSW was increased at five years as compared to pre-treatment values: +0,43mm (CI:0,02-0,84; p=0.040).…”

mentioning

confidence: 89%

THU0439 Accurate Intra-Articular Placement Does not Result in Superior Pain Reduction Following Clinically Guided Corticosteroid Injection in Knee Osteoarthritis; Findings of an Observational Cohort

Hirsch¹,

O’Neill

Kitas

et al. 2015

Annals of the Rheumatic Diseases

View full text Add to dashboard Cite

BackgroundIntra-articular corticosteroid injections (IACI) are effective treatments for pain in knee osteoarthritis (OA), but responses to treatment vary. Uncertainty remains as to whether structural factors including accurate intra-articular injection placement influence outcome.ObjectivesTo determine whether structural factors including sonographically determined accuracy of IACI placement influence pain reduction in knee OA.MethodsIn a pragmatic prospective observational study, 141 subjects with knee osteoarthritis (mean age 63.8 years, 62% female) routinely referred for IACI underwent assessment of personal and demographic factors, x-rays (AP, lateral and sky-line patellofemoral) and ultrasound (US) before aspiration and injection of the joint, guided by clinical examination. US demonstration of an air-arthrosonogram was used to determine whether injections entered the joint cavity. Pain severity at baseline and at three and nine weeks post injection was assessed using the 500mm WOMAC pain subscale. Mean baseline pain was 271 (SD 96.7).Response to injection was defined as 40% reduction in pain from baseline. Characteristics of responders and non responders and mean change in pain for “accurate” intra-articular vs “inaccurate” extra-articular injections were compared using univariate statistics with the aim of creating logistic regression models. Inter-observer reliability of the air-arthrosonogram assessment was calculated as mean kappa of 0.79 for agreement between three raters.ResultsEighty-three subjects (53%) were classified responders at three weeks and fifty-six (44%)at nine weeks. Ninety-eight subjects (70%) had a positive arthrosonogram.Accurate injection neither resulted in a higher rate of response to treatment than inaccurate injection (57.7% vs 63.4% p0.355 at three weeks,39.3% vs 51.4% p 0.148 at nine weeks) nor greater mean pain reduction (-110.7 vs -116.9 mm VAS, p 0.781 at three weeks, and -65.2 vs -92.8, p 0.247 at nine). There were no differences in mean measurements of sonographic effusion and synovial hypertrophy, or scores for power Doppler signal and individual radiographic features of osteoarthritis (joint space narrowing and osteophytes) between responders and non responders at three or nine weeks. Those who had received previous injection were less likely to respond at nine weeks (p 0.026, OR 0.41, CI 0.20-0.86) and responders at nine weeks had lower mean baseline pain score compared to non-responders (250 vs 288 mm respectively, p 0.031)ConclusionsWe found no evidence that accurate injection of corticosteroid results in superior outcome to inaccurate injection in knee OA, nor that physical factors including sonographic features of synovial inflammation or radiographic severity influence outcome. These results raise potential questions about the routine use of US to enhance or predict response to IACI in knee OA.Disclosure of InterestNone declared

show abstract

“…В большинстве современных руководств, включая OARSI (Osteoarthritis Research Society International) [15], ACR (American College of Rheumatology) [16], AAOS (American Academy of Orthopaedic Surgeons) [17], NICE (National Institute for Health and Care Excellence) [18] и EULAR (European League Against Rheumatism) [19], рекомендуется использовать для местного и внутреннего применения нестероидные противовоспалительные препараты (НПВП), трамадол, парацетамол, капсаицин и внутрисуставные инъекции кортикостероидов. Европейское общество клинических и экономических исследований «Аспекты остеопороза и остеоартроза» (European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis; ESCEO) опубликовало алгоритм-рекомендацию, включающую в себя назначение симптоматических препаратов замедленного действия (Symptomatic slow acting drugs for osteoarthritis; SYSADOA), способствующих замедлению деградации компонентов хряща и прогрессирования болезни уже на первом этапе лечения [20]. Однако отношение к этим рекомендациям неоднозначное, поскольку препараты SYSADOA в основном представлены внутрисуставными инъекциями глюкозамина сульфата, хондроитина сульфата и гиалуроновой кислоты [20,21].…”

Section: биорегуляционная терапия болевого синдромаunclassified

“…Европейское общество клинических и экономических исследований «Аспекты остеопороза и остеоартроза» (European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis; ESCEO) опубликовало алгоритм-рекомендацию, включающую в себя назначение симптоматических препаратов замедленного действия (Symptomatic slow acting drugs for osteoarthritis; SYSADOA), способствующих замедлению деградации компонентов хряща и прогрессирования болезни уже на первом этапе лечения [20]. Однако отношение к этим рекомендациям неоднозначное, поскольку препараты SYSADOA в основном представлены внутрисуставными инъекциями глюкозамина сульфата, хондроитина сульфата и гиалуроновой кислоты [20,21].…”

Section: биорегуляционная терапия болевого синдромаunclassified

Bioregulatory drugs in osteoarthritis management

Shavlovskaya

2019

Med. sov.

View full text Add to dashboard Cite

Osteoarthritis (OA) is a degenerative joint disease. Modern theories consider various structural (cartilage destruction) and biophysical disorders (matrix loss of glycosaminoglycans) as the basis of acute and chronic pain syndrome. The main aim of OA therapy is pain relief and functional improvement. To manage pain syndrome in OA it is reasonable to use complex bioregulatory drugs (CBD) (Traumeel S, Zeel T, Discus compositum) both in monotherapy and in combined treatment. The effectiveness of CBD is comparable to that of NSAIDs and CS.

show abstract

A double-blind, randomized, saline-controlled study of the efficacy and safety of co-administered intra-articular injections of Tr14 and Ze14 for treatment of painful osteoarthritis of the knee: The MOZArT trial

Cited by 17 publications

References 31 publications

Intra-articular treatment options for knee osteoarthritis

Intra-articular treatment options for knee osteoarthritis

THU0439 Accurate Intra-Articular Placement Does not Result in Superior Pain Reduction Following Clinically Guided Corticosteroid Injection in Knee Osteoarthritis; Findings of an Observational Cohort

Bioregulatory drugs in osteoarthritis management

Contact Info

Product

Resources

About