Back to resultsNew Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis (PROMGEL-OA)
Primary Purpose
Osteoarthritis, Knee, Pain
Status
Active
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Hydrogel injection
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, pain, knee
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- CEMIC
- DOM Centro de Reumatología
- IADT
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Subjects who will receive an injection of the hydrogel
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Improvement of Quality of life: KOOS
Quality of life (QoL-Status) - defined as improvement of the QoL of the subjects, compared to the baseline values for KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire.
The KOOS questionnaire was developed as an instrument to assess the patient's opinion about their knee and associated problems.The KOOS questionnaire measures 5 subscales: pain referred by the patient, other specific symptoms of the disease, function in daily life activities, function in sport and recreation and quality of life related to the knee. All items have 5 possible response options (from 0 to 4) where 0 indicates no problems and 4 indicates extreme problems, and each of those 5 scores is calculated as the sum of the included items. The scores are transformed on a scale of 0 to 100, which 0 represents extreme knee problems and 100 indicates no symptoms. The score ranges from 0 to 100, separately for each sub-scale. A change of 10 points or more is considered a clinically significant change.
Improvement of Health status
Health Status assessed with 12-Item Short-Form Health Survey (SF-12). It consists of 12 items (grouped in 8 health concepts: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health) from which two summaries are constructed: physical and mental. The higher the score on the scales indicates the better health.
Patient Global Impression
Patient Global Impression with the his/her osteoarthritis will be evaluated with a visual analogue scale (Wong-Baker scale) where Face 0: represents an inactive osteoarthritis, that is, without symptoms and Face 10: represents a very active osteoarthritis, that is, with severe symptoms.
Rate of Adverse Events
All adverse events will be registered.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04061733
Brief Title
New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
Acronym
PROMGEL-OA
Official Title
New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Promedon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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. The working hypothesis is that the effect of hydrogel use on the study population will result in a reduction in pain in the knees affected by symptomatic OA.
The general objective of this study is to generate clinical evidence of the safety and efficacy of the new hydrogel used as a treatment of symptomatic knee osteoarthritis.
The patient's perception of the pain caused by osteoarthritis in the knee joint before and after the treatment under evaluation will be quantify. Subjects' quality of life before and after treatment will also be evaluated. Monitoring of the adverse events associated with the use of the device under evaluation will be determined. Subjects will be follow-up for 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Pain
Keywords
osteoarthritis, pain, knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multicenter
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Subjects who will receive an injection of the hydrogel
Intervention Type
Device
Intervention Name(s)
Hydrogel injection
Intervention Description
Hydrogel injection
Primary Outcome Measure Information:
Title
Pain assessment: Percentage of pain reduction using a visual analogue scale
Description
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
Time Frame
Change from Baseline at postoperative 12 months follow-up
Secondary Outcome Measure Information:
Title
Improvement of Quality of life: KOOS
Description
Quality of life (QoL-Status) - defined as improvement of the QoL of the subjects, compared to the baseline values for KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire.
The KOOS questionnaire was developed as an instrument to assess the patient's opinion about their knee and associated problems.The KOOS questionnaire measures 5 subscales: pain referred by the patient, other specific symptoms of the disease, function in daily life activities, function in sport and recreation and quality of life related to the knee. All items have 5 possible response options (from 0 to 4) where 0 indicates no problems and 4 indicates extreme problems, and each of those 5 scores is calculated as the sum of the included items. The scores are transformed on a scale of 0 to 100, which 0 represents extreme knee problems and 100 indicates no symptoms. The score ranges from 0 to 100, separately for each sub-scale. A change of 10 points or more is considered a clinically significant change.
Time Frame
Baseline, and postoperative at 1, 3, 6 and 12 months follow-up
Title
Improvement of Health status
Description
Health Status assessed with 12-Item Short-Form Health Survey (SF-12). It consists of 12 items (grouped in 8 health concepts: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health) from which two summaries are constructed: physical and mental. The higher the score on the scales indicates the better health.
Time Frame
Change from Baseline at postoperative at 1, 3, 6 and 12 months follow-up
Title
Patient Global Impression
Description
Patient Global Impression with the his/her osteoarthritis will be evaluated with a visual analogue scale (Wong-Baker scale) where Face 0: represents an inactive osteoarthritis, that is, without symptoms and Face 10: represents a very active osteoarthritis, that is, with severe symptoms.
Time Frame
Change from Baseline, up to three days after injection, postoperative at 1, 3, 6 and 12 months follow-up
Title
Rate of Adverse Events
Description
All adverse events will be registered.
Time Frame
At injection, at three days after injection, postoperative at 1, 3, 6 and 12 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando E. Barclay, Dr.
Organizational Affiliation
IADT
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEMIC
City
Buenos Aires
Country
Argentina
Facility Name
DOM Centro de Reumatología
City
Buenos Aires
Country
Argentina
Facility Name
IADT
City
Buenos Aires
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24141714
Citation
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.
Results Reference
background
PubMed Identifier
3741515
Citation
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.
Results Reference
background
PubMed Identifier
2673078
Citation
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.
Results Reference
background
PubMed Identifier
21684382
Citation
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.
Results Reference
background
PubMed Identifier
19762361
Citation
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.
Results Reference
background
PubMed Identifier
16625635
Citation
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.
Results Reference
background
PubMed Identifier
20699159
Citation
Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001. Erratum In: Clin Geriatr Med. 2013 May;29(2):ix.
Results Reference
background
PubMed Identifier
24792942
Citation
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.
Results Reference
background
PubMed Identifier
25775186
Citation
Allen KD, Golightly YM. State of the evidence. Curr Opin Rheumatol. 2015 May;27(3):276-83. doi: 10.1097/BOR.0000000000000161.
Results Reference
background
PubMed Identifier
26107064
Citation
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.
Results Reference
background
PubMed Identifier
23337796
Citation
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.
Results Reference
background
PubMed Identifier
7639811
Citation
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.
Results Reference
background
PubMed Identifier
26619838
Citation
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.
Results Reference
background
PubMed Identifier
19751691
Citation
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.
Results Reference
background
PubMed Identifier
20305774
Citation
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. Erratum In: Dtsch Arztebl Int. 2010 Apr;107(16):294.
Results Reference
background
PubMed Identifier
24288804
Citation
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.
Results Reference
background
PubMed Identifier
26005358
Citation
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.
Results Reference
background
PubMed Identifier
25328555
Citation
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.
Results Reference
background
PubMed Identifier
19304567
Citation
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.
Results Reference
background
PubMed Identifier
22294639
Citation
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.
Results Reference
background
PubMed Identifier
24218162
Citation
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.
Results Reference
background
PubMed Identifier
17448701
Citation
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.
Results Reference
background
PubMed Identifier
20170770
Citation
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.
Results Reference
background
PubMed Identifier
22868835
Citation
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.
Results Reference
background
PubMed Identifier
23143387
Citation
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.
Results Reference
background
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New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
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