New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis

NCT04061733 | Unknown

• 1 other identifier: PROMGEL-OA-2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

Prospective, multicenter study, unmasked, single-arm, to study the safety and efficacy of a new hydroxyethyl cellulose hydrogel for the treatment of the knee pain caused by osteoarthritis.

Conditions

Osteoarthritis, Knee; Pain

Keywords

osteoarthritis; pain; knee

Outcome Measures

Primary Outcomes (1)

• Pain assessment: Percentage of pain reduction using a visual analogue scale

  Percentage of pain reduction using a visual analogue scale (Wong-Baker scale) where Face 0: does not hurt at all and Face 10: hurts as much as you can imagine

  Change from Baseline at postoperative 12 months follow-up

Secondary Outcomes (4)

• Improvement of Quality of life: KOOS

  Baseline, and postoperative at 1, 3, 6 and 12 months follow-up

• Improvement of Health status

  Change from Baseline at postoperative at 1, 3, 6 and 12 months follow-up

• Patient Global Impression

  Change from Baseline, up to three days after injection, postoperative at 1, 3, 6 and 12 months follow-up

• Rate of Adverse Events

  At injection, at three days after injection, postoperative at 1, 3, 6 and 12 months follow-up

Study Arms (1)

Experimental

EXPERIMENTAL

Subjects who will receive an injection of the hydrogel

Device: Hydrogel injection

Interventions

Hydrogel injection DEVICE

Hydrogel injection

Experimental

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed with osteoarthritis of unilateral or bilateral knee osteoarthritis who meet the criteria defined by the American College of Rheumatology for at least 4 months prior to the study. In bilateral knee osteoarthritis, only the knee with more symptoms will be treated.
• Arthrosis grade 2 or 3 according to the Kellgren - Lawrence Classification System (radiological classification)
• Persistence of symptoms despite conservative treatment (NSAIDS, Physical Therapy, lifestyle changes, etc.) for more than 4 months
• Subjects aged between 40 and 70 years
• BMI (Kg/m²) 20-32
• For female subjects: postmenopausal women with at least 1 year documented in the medical record.

You may not qualify if:

• Arthrosis grade 0 or 4 according to the Kellgren - Lawrence Classification
• History of allergy to any of the Hydrogel components
• History of previous treatment with corticosteroid injections less than 4 months prior to entry into this clinical study
• History of previous treatment with hyaluronic acid viscosupplementation
• History of open or arthroscopic surgery in the knee to be treated less than 9 months
• Severe chronic progressive disease
• Insulin-requiring diabetes
• Rheumatic diseases (rheumatoid arthritis, psoriasis, gout, pseudo-gout, fibromyalgia)
• History of septic arthritis
• History of psychiatric illness that makes it impossible to understand and sign the informed consent
• History or presence of severe peripheral vascular disease
• Deseje over 15° valgus or varus movement
• Pregnant or breastfeeding women
• BMI (kg/m²)\> 32

Sponsors & Collaborators

• Promedon: lead

Study Sites (3)

CEMIC

Buenos Aires, Argentina

Location

DOM Centro de Reumatología

Buenos Aires, Argentina

Location

IADT

Buenos Aires, Argentina

Location

Related Publications (25)

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

  PMID: 24141714 BACKGROUND

• Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.

  PMID: 3741515 BACKGROUND

• McAlindon T, Dieppe P. Osteoarthritis: definitions and criteria. Ann Rheum Dis. 1989 Jul;48(7):531-2. doi: 10.1136/ard.48.7.531. No abstract available.

  PMID: 2673078 BACKGROUND

• Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011 Jun 18;377(9783):2115-26. doi: 10.1016/S0140-6736(11)60243-2.

  PMID: 21684382 BACKGROUND

• Zhang W, Doherty M, Peat G, Bierma-Zeinstra MA, Arden NK, Bresnihan B, Herrero-Beaumont G, Kirschner S, Leeb BF, Lohmander LS, Mazieres B, Pavelka K, Punzi L, So AK, Tuncer T, Watt I, Bijlsma JW. EULAR evidence-based recommendations for the diagnosis of knee osteoarthritis. Ann Rheum Dis. 2010 Mar;69(3):483-9. doi: 10.1136/ard.2009.113100. Epub 2009 Sep 17.

  PMID: 19762361 BACKGROUND

• Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD005321. doi: 10.1002/14651858.CD005321.pub2.

  PMID: 16625635 BACKGROUND

• Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

  PMID: 20699159 BACKGROUND

• Johnson VL, Hunter DJ. The epidemiology of osteoarthritis. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):5-15. doi: 10.1016/j.berh.2014.01.004.

  PMID: 24792942 BACKGROUND

• Allen KD, Golightly YM. State of the evidence. Curr Opin Rheumatol. 2015 May;27(3):276-83. doi: 10.1097/BOR.0000000000000161.

  PMID: 25775186 BACKGROUND

• Hunter DJ. Viscosupplementation for Osteoarthritis of the Knee. N Engl J Med. 2015 Jun 25;372(26):2570. doi: 10.1056/NEJMc1505801. No abstract available.

  PMID: 26107064 BACKGROUND

• Litwic A, Edwards MH, Dennison EM, Cooper C. Epidemiology and burden of osteoarthritis. Br Med Bull. 2013;105:185-99. doi: 10.1093/bmb/lds038. Epub 2013 Jan 20.

  PMID: 23337796 BACKGROUND

• Oliveria SA, Felson DT, Reed JI, Cirillo PA, Walker AM. Incidence of symptomatic hand, hip, and knee osteoarthritis among patients in a health maintenance organization. Arthritis Rheum. 1995 Aug;38(8):1134-41. doi: 10.1002/art.1780380817.

  PMID: 7639811 BACKGROUND

• Plotnikoff R, Karunamuni N, Lytvyak E, Penfold C, Schopflocher D, Imayama I, Johnson ST, Raine K. Osteoarthritis prevalence and modifiable factors: a population study. BMC Public Health. 2015 Nov 30;15:1195. doi: 10.1186/s12889-015-2529-0.

  PMID: 26619838 BACKGROUND

• Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.

  PMID: 19751691 BACKGROUND

• Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5.

  PMID: 20305774 BACKGROUND

• Jevsevar DS, Brown GA, Jones DL, Matzkin EG, Manner PA, Mooar P, Schousboe JT, Stovitz S, Sanders JO, Bozic KJ, Goldberg MJ, Martin WR 3rd, Cummins DS, Donnelly P, Woznica A, Gross L; American Academy of Orthopaedic Surgeons. The American Academy of Orthopaedic Surgeons evidence-based guideline on: treatment of osteoarthritis of the knee, 2nd edition. J Bone Joint Surg Am. 2013 Oct 16;95(20):1885-6. doi: 10.2106/00004623-201310160-00010. No abstract available.

  PMID: 24288804 BACKGROUND

• Strand V, McIntyre LF, Beach WR, Miller LE, Block JE. Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials. J Pain Res. 2015 May 7;8:217-28. doi: 10.2147/JPR.S83076. eCollection 2015.

  PMID: 26005358 BACKGROUND

• Pal S, Thuppal S, Reddy KJ, Avasthi S, Aggarwal A, Bansal H, Mohanasundaram S, Bailleul F. Long-Term (1-Year) Safety and Efficacy of a Single 6-mL Injection of Hylan G-F 20 in Indian Patients with Symptomatic Knee Osteoarthritis. Open Rheumatol J. 2014 Oct 2;8:54-68. doi: 10.2174/1874312901408010054. eCollection 2014.

  PMID: 25328555 BACKGROUND

• Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis. 2010 Jan;69(1):113-9. doi: 10.1136/ard.2008.094623.

  PMID: 19304567 BACKGROUND

• Berenbaum F, Grifka J, Cazzaniga S, D'Amato M, Giacovelli G, Chevalier X, Rannou F, Rovati LC, Maheu E. A randomised, double-blind, controlled trial comparing two intra-articular hyaluronic acid preparations differing by their molecular weight in symptomatic knee osteoarthritis. Ann Rheum Dis. 2012 Sep;71(9):1454-60. doi: 10.1136/annrheumdis-2011-200972. Epub 2012 Jan 31.

  PMID: 22294639 BACKGROUND

• Evaniew N, Simunovic N, Karlsson J. Cochrane in CORR(R): Viscosupplementation for the treatment of osteoarthritis of the knee. Clin Orthop Relat Res. 2014 Jul;472(7):2028-34. doi: 10.1007/s11999-013-3378-8. Epub 2013 Nov 12. No abstract available.

  PMID: 24218162 BACKGROUND

• Campbell J, Bellamy N, Gee T. Differences between systematic reviews/meta-analyses of hyaluronic acid/hyaluronan/hylan in osteoarthritis of the knee. Osteoarthritis Cartilage. 2007 Dec;15(12):1424-36. doi: 10.1016/j.joca.2007.01.022. Epub 2007 Apr 19.

  PMID: 17448701 BACKGROUND

• Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.

  PMID: 20170770 BACKGROUND

• Rutjes AW, Juni P, da Costa BR, Trelle S, Nuesch E, Reichenbach S. Viscosupplementation for osteoarthritis of the knee: a systematic review and meta-analysis. Ann Intern Med. 2012 Aug 7;157(3):180-91. doi: 10.7326/0003-4819-157-3-201208070-00473.

  PMID: 22868835 BACKGROUND

• Vaquero J, Longo UG, Forriol F, Martinelli N, Vethencourt R, Denaro V. Reliability, validity and responsiveness of the Spanish version of the Knee Injury and Osteoarthritis Outcome Score (KOOS) in patients with chondral lesion of the knee. Knee Surg Sports Traumatol Arthrosc. 2014 Jan;22(1):104-8. doi: 10.1007/s00167-012-2290-1. Epub 2012 Nov 10.

  PMID: 23143387 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando E. Barclay, Dr.

  IADT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 20, 2019
• Study Start: September 30, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2024
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

AR (3)