Hydros Joint Therapy and Hydros TA for Pain Associated with Knee Osteoarthritis; A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of Hydros Joint Therapy and Hydros TA for Management of Pain Associated with Osteoarthritis in the Knee

Completed

• Conditions: Joint damage; joint degeration; 10023213

• Registration Number: NL-OMON34625
• Lead Sponsor: Carbylan BioSurgery, Inc.

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2011-06-30
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. Osteoarthritis (OA) grade 2 or 3 in one knee using Kellgren-Lawrence Grading for OA radiologically and verified within the prior 6 months.
a. Grade 2 defined as definite osteophytes with unimpaired joint space
b. Grade 3 defined as definite osteophytes with moderate joint space narrowing
2. Treatment knee criteria:
a. WOMAC Pain subscale score of 50-90 mm on a Visual Analogue Scale (VAS) (where 0 <= no pain and 100 mm <= worst pain) for the average of the five pain questions, and
b. One WOMAC Pain subscale score allowed to be below 20 mm or above 90 mm on the VAS.
3. Non-treatment knee WOMAC Pain subscale score less than or equal to 30 mm average of the five pain questions.
4. Symptoms in the treatment knee for at least 12 months.
5. Fully ambulatory subject (ability to perform a 15 meters walk test).
6. Male and female subjects 40 through 85 years of age.
7. Willing to NOT take any pain medication for 48 hours prior to each study visit and provide a list of pain medications taken between visits.
NOTE: Subject may take the following during the study:
a. Up to a maximum of 4 gm. paracetamol (acetaminophen) daily for treatment knee pain.
b. Single daily low dose ASA up to 325 mg.
c. Short term (3 days or less) NSAIDs for pain of origin other than treatment knee.
8. Written consent to participate in the clinical study following subject*s review of the COR 1.0 Study Subject Information and Consent form.
9. Able to understand the requirements of the study and willing to comply with all treatment and study evaluations for the duration of the trial.
10. Females of childbearing potential must not be or become pregnant for the duration of the study.

Exclusion Criteria

1. Non-treatment knee joint pain greater than 30 mm average WOMAC Pain subscale scores.
2. Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
3. Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments. Diagnosis is from medical history or prior xrays. Upper extremity OA is NOT excluded.
4. Active infection in either knee joint or adjacent tissues or positive synovial fluid culture of any joint.
5. Any contraindications for intra-articular injection or aspiration.
6. Knee surgery or trauma within 3 months prior to enrollment or planned joint surgery for the period of study duration.
7. Intra-articular steroid injection in the knee and/or use of systemic (oral) corticosteroids within 3 months prior to enrollment. Inhaled steroids are NOT excluded.
8. Intra-articular hyaluronan injection in the treatment knee within 6 months prior to enrollment.
9. BMI greater than 35.
10. Known hypersensitivity/allergic/anaphylactic reactions to local anesthetics.
11. Known sensitivity to avian proteins, corticosteroids, or hyaluronan-based products.
12. Arthroscopy of either knee or in any other joint within one (1) month prior to enrollment.
13. Started the use of glucosamine, chondroitin sulfate, diacerhein, or avocado/soya extracts within 2 months prior to Screening.
14. Current treatment with systemic steroids, narcotic analgesics, acetylsalicylic acid (ASA) greater than 325 mg daily, NSAIDs, COX inhibitors, or joint creams (e.g. methylsalicylate or capsaicin).
NOTE: Subject may take the following during the study:
a. Up to a maximum of 4 gm. paracetamol daily for treatment knee pain.
b. Single daily low dose ASA up to 325 mg.
c. Short term (3 days or less) NSAIDs for pain of origin other than treatment knee.
15. Current uncontrolled diabetes mellitus.
16. Current use of intra-articular injections.
17. Clinically significant conditions that would interfere with accuracy of study evaluations, e.g. malignant neoplastic disease, intra-articular tumor, fibromyalgia, peripheral neuropathy, vascular insufficiency, hemiparesis, significant psychiatric or neurological disorders, active alcohol/drug abuse, or other factors that the investigator feels would interfere with study evaluations and study participation.
18. Participation in another clinical trial and/or treatment received with any investigational agent within 30 days before enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints<br /><br><br /><br>Effectiveness<br /><br><br /><br>WOMAC Pain Subscale Score<br /><br>The WOMAC Pain Subscale is used to assess the severity of the knee pain at<br /><br>Screening, Week 2 Follow-up, Week 6 Follow-up, Week 13 Follow-up, and Week 26<br /><br>Follow-up visits. For each subject the scores of the five questions that<br /><br>comprise the WOMAC Pain subscale are averaged.<br /><br>The primary endpoint is the time-weighted change from baseline in the WOMAC<br /><br>Pain sub-scale average score in the treatment knee.<br /><br>Secondary analyses include the change from baseline to week 13 and change from<br /><br>baseline to week 26.<br /><br><br /><br>Safety<br /><br><br /><br>The safety and tolerability of Hydros and Hydros TA will be evaluated by<br /><br>comparison of Adverse Event (AE) rates. AEs will be followed through<br /><br>resolution or 30 days after the subject terminates from the study, whichever<br /><br>occurs first. </p><br>