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New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis (PROMGEL-OA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04061733
Recruitment Status : Active, not recruiting
First Posted : August 20, 2019
Last Update Posted : December 29, 2022
Sponsor:
Information provided by (Responsible Party):
Promedon

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Pain Device: Hydrogel injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multicenter
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Subjects who will receive an injection of the hydrogel
Device: Hydrogel injection
Hydrogel injection




Primary Outcome Measures :
  1. Pain assessment: Percentage of pain reduction using a visual analogue scale [ Time Frame: Change from Baseline at postoperative 12 months follow-up ]
    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 :
  1. Improvement of Quality of life: KOOS [ Time Frame: Baseline, and postoperative at 1, 3, 6 and 12 months follow-up ]

    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.


  2. Improvement of Health status [ Time Frame: Change from Baseline at postoperative at 1, 3, 6 and 12 months follow-up ]
    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.

  3. Patient Global Impression [ Time Frame: Change from Baseline, up to three days after injection, postoperative at 1, 3, 6 and 12 months follow-up ]
    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.

  4. Rate of Adverse Events [ Time Frame: At injection, at three days after injection, postoperative at 1, 3, 6 and 12 months follow-up ]
    All adverse events will be registered.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061733


Locations
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Argentina
CEMIC
Buenos Aires, Argentina
DOM Centro de Reumatología
Buenos Aires, Argentina
IADT
Buenos Aires, Argentina
Sponsors and Collaborators
Promedon
Investigators
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Principal Investigator: Fernando E. Barclay, Dr. IADT
Publications:

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Responsible Party: Promedon
ClinicalTrials.gov Identifier: NCT04061733    
Other Study ID Numbers: PROMGEL-OA-2018
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: December 29, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Promedon:
osteoarthritis
pain
knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases