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

Sponsor
Promedon (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04061733
Collaborator
(none)
50
Enrollment
3
Locations
1
Arm
58
Anticipated Duration (Months)
16.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hydrogel injection
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, multicenterProspective, 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 :
Sep 30, 2019
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Subjects who will receive an injection of the hydrogel

Device: Hydrogel injection
Hydrogel injection

Outcome Measures

Primary Outcome Measures

  1. Pain assessment: Percentage of pain reduction using a visual analogue scale [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 [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 [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 [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 [At injection, at three days after injection, postoperative at 1, 3, 6 and 12 months follow-up]

    All adverse events will be registered.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CEMIC Buenos Aires Argentina
2 DOM Centro de Reumatología Buenos Aires Argentina
3 IADT Buenos Aires Argentina

Sponsors and Collaborators

  • Promedon

Investigators

  • Principal Investigator: Fernando E. Barclay, Dr., IADT

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Promedon
ClinicalTrials.gov Identifier:
NCT04061733
Other Study ID Numbers:
  • PROMGEL-OA-2018
First Posted:
Aug 20, 2019
Last Update Posted:
May 4, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Osteoarthritis
Osteoarthritis, Knee

Study Results

No Results Posted as of May 4, 2022