Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Knee Osteoarthritis With PAAG-OA (ROSA)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04045431
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Contura

Brief Summary:
This is a multi-center, randomized, double-blind clinical investigation to compare the effectiveness of intra-articular polyacrylamide hydrogel (PAAG-OA) and a hyaluronic acid, Synvisc-One to induce symptomatic benefit in subjects with knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: PAAG-OA Device: Synvisc-One Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The subject and study staff will not know the treatment received. Only the unblinded injector will know the treatment.
Primary Purpose: Treatment
Official Title: A Multi-centre Randomized, Controlled, Double-blind Clinical Investigation of Intra-articular Polyacrylamide Hydrogel in Subjects With Knee Osteoarthritis
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: PAAG-OA
Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)
Device: PAAG-OA
Intra-articular injection of 6ml PAAG-OA in the target knee

Active Comparator: Synvisc-One
Intra-articular injection with Synvisc-One (hyaluronic acid)
Device: Synvisc-One
Intra-articular injection of 6ml Synvisc-One in the target knee




Primary Outcome Measures :
  1. Comparing one injection of PAAG-OA with one injection of Synvisc-One on pain over 6 months in subjects with knee osteoarthritis [ Time Frame: 6 months ]
    Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale. Pain is reported in each of five response categories (0=none, 4=extreme)


Secondary Outcome Measures :
  1. WOMAC [ Time Frame: 1, 3, 6 and 12 months ]
    WOMAC (WOMAC Osteoarthritis Index) self reported pain, stiffness and physical function, categories (0=none, 4=extreme)

  2. PGA (Patient Global Assessment) [ Time Frame: 1, 3, 6 and 12 months ]
    PGA reported on a 10 cm Visual Analogue Scale

  3. EQ-5D-5L, QoL [ Time Frame: 1, 3, 6 and 12 months ]
    EQ-5D-5L, Quality of Life, comprised of descriptive system where each dimension has 5 levels (ranging from no problems to extreme problems) and a 20 cm Visual Analogue Scale (0 = worst health and 100 = best health)

  4. OMERACT-OARSI responder criteria [ Time Frame: 1, 3, 6 and 12 months ]

    Per the OMERACT-OARSI criteria, a subject is classified as a positive responder if at least one (1) of the following two (2) conditions is observed at the post-baseline assessment:

    • In either pain (WOMAC pain subscale) or function (WOMAC function subscale), a high improvement in the subscale, where high improvement in a subscale is achieved if there is both a > 50% improvement from Baseline and an absolute change from Baseline of > 20 normalised units (0-100 scale) OR
    • Improvement in at least two (2) of the following three (3):

      1. Improvement in pain (WOMAC pain subscale) defined as > 20% improvement from Baseline and an absolute change from Baseline of > 10 (0-100 scale)
      2. Improvement in function (WOMAC function subscale) defined as > 20% improvement from Baseline and an absolute change from Baseline of > 10 (0-100 scale)
      3. Improvement in PGA defined as > 20% improvement from Baseline and an absolute change from Baseline of > 10 mm (0-100 sc



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged ≥ 40 years
  • Clinical diagnosis of knee OA American College of Rheumatology criteria confirmed by radiology
  • Definite radiographic OA in the most symptomatic knee (target knee) at mild to moderate-stage (Kellgren-Lawrence grades 2 or 3)
  • Stable dose of analgesics for the past four weeks
  • NRS (11 points (0-10) pain intensity numerical rating scale) ≥ 4 in target knee, during the past week when walking
  • Body Mass Index (BMI) between 20-35
  • For females of reproductive potential: use of adequate contraception must be used throughout the trial

Exclusion Criteria:

  • Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation
  • Contraindications to PAAG-OA or Synvisc-One®, according to IB or Instruction for Use (IFU)
  • Previous intra-articular injection of polyacrylamide gel in the target knee
  • Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months
  • Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability
  • Other diseases in target knee than osteoarthritis
  • Intra-articular injection of any substance other than hyaluronic acid (e.g. corticosteroids) in the target knee within the last 3 months
  • Acute serious infection of any region that required hospital care or intravenous antibiotic treatment within the last 30 days, or oral antibiotic treatment within the last 14 days
  • Skin disease or infections in the area of the injection site
  • Infected or severely inflamed knees
  • History of sepsis in any joint or any clinical concern for a subacute infectious process in the target knee
  • History of surgery in the target knee within the past 6 months
  • Symptomatic osteoarthritis of the hips, spine or ankle, that interferes with the evaluation of the target knee
  • Planned surgery on any lower extremity
  • Clinically significant venous or lymphatic stasis present in the legs
  • Clinically apparent tense effusion or inflammation in the target knee
  • Suffering from any unstable or severe cardio-vascular disease
  • Any contraindication to intra-articular e.g. anticoagulant therapy or clinical concern for potential coagulopathy (e.g. liver disease)
  • Any foreign material in the target joint
  • Any significant medical condition (e.g. significant psychiatric or neurological disorders or active alcohol/drug abuse), any medical condition that is unstable/poorly controlled or other factors that may interfere with study participation
  • Treatment with systemic steroids
  • History of drug/alcohol abuse, mental dysfunction of other factors limiting their ability to cooperate fully
  • Change in physiotherapy within the previous month
  • Fibromyalgia
  • Inflammatory or other disease/condition which may affect joints (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others)
  • Haemophilia
  • Any other condition that in the opinion of the investigator put a potential participant at risk or otherwise precludes participation in the trial
  • Known allergic reactions to components of Synvisc-One (avian protein)
  • Known allergic reactions to antibiotics (azithromycin and moxifloxacin) or local anaesthesia
  • Participation in any experimental device study within 6 months prior to enrolment, or participation in an experimental drug study within 1 month prior to enrolment

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): NCT04045431


Contacts
Layout table for location contacts
Contact: Anette Nawrocki +4521480045 anette.nawrocki@contura.com

Locations
Layout table for location information
Denmark
The Parker Institute Recruiting
Frederiksberg, Denmark
A2 Reumatologi og idrætsmedicin Recruiting
Hillerød, Denmark
Reumatolog i Odense Not yet recruiting
Odense, Denmark
Sponsors and Collaborators
Contura
Investigators
Layout table for investigator information
Principal Investigator: Henning Bliddal, MD The Parker Institute

Layout table for additonal information
Responsible Party: Contura
ClinicalTrials.gov Identifier: NCT04045431     History of Changes
Other Study ID Numbers: CON-OA-001
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hylan
Hyaluronic Acid
Viscosupplements
Protective Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors