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

December 27, 2022 updated by: Promedon
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • CEMIC
      • Buenos Aires, Argentina
        • DOM Centro de Reumatología
      • Buenos Aires, Argentina
        • IADT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline at postoperative 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, and postoperative at 1, 3, 6 and 12 months follow-up
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.
Change from Baseline at postoperative at 1, 3, 6 and 12 months follow-up
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.
Change from Baseline, up to three days after injection, postoperative at 1, 3, 6 and 12 months follow-up
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.
At injection, at three days after injection, postoperative at 1, 3, 6 and 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Promedon

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

August 16, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROMGEL-OA-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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