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

Pain Clinical Trial

— PROMGEL-OA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04061733
• Other study ID #: PROMGEL-OA-2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2022
• Source: Promedon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Arthrosis grade 2 or 3 according to the Kellgren - Lawrence Classification System (radiological classification)

3. Persistence of symptoms despite conservative treatment (NSAIDS, Physical Therapy, lifestyle changes, etc.) for more than 4 months

4. Subjects aged between 40 and 70 years

5. BMI (Kg/m²) 20-32

6. For female subjects: postmenopausal women with at least 1 year documented in the medical record.

Exclusion Criteria:

1. Arthrosis grade 0 or 4 according to the Kellgren - Lawrence Classification

2. History of allergy to any of the Hydrogel components

3. History of previous treatment with corticosteroid injections less than 4 months prior to entry into this clinical study

4. History of previous treatment with hyaluronic acid viscosupplementation

5. History of open or arthroscopic surgery in the knee to be treated less than 9 months

6. Severe chronic progressive disease

7. Insulin-requiring diabetes

8. Rheumatic diseases (rheumatoid arthritis, psoriasis, gout, pseudo-gout, fibromyalgia)

9. History of septic arthritis

10. History of psychiatric illness that makes it impossible to understand and sign the informed consent

11. History or presence of severe peripheral vascular disease

12. Deseje over 15° valgus or varus movement

13. Pregnant or breastfeeding women

14. BMI (kg/m²)> 32

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Device:
• Hydrogel injection
Hydrogel injection

Locations

Country	Name	City	State
Argentina	CEMIC	Buenos Aires
Argentina	DOM Centro de Reumatología	Buenos Aires
Argentina	IADT	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Promedon

Country where clinical trial is conducted

Argentina, 

References & Publications (25)

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

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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. — View Citation

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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. — View 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. — View 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. — View 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. — View Citation

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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. — View 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. — View 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. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, and postoperative at 1, 3, 6 and 12 months follow-up
Secondary	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.	Change from Baseline at postoperative at 1, 3, 6 and 12 months follow-up
Secondary	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.	Change from Baseline, up to three days after injection, postoperative at 1, 3, 6 and 12 months follow-up
Secondary	Rate of Adverse Events	All adverse events will be registered.	At injection, at three days after injection, postoperative at 1, 3, 6 and 12 months follow-up