KIO014 is an innovative chitosan-based biomaterial intended for synovial fluid viscosupplementation indicated for the symptomatic treatment of knee osteoarthritis (OA). The study KIO014-APROOVE is aimed to evaluate the safety and performance of KIO014 in patients with symptomatic knee OA. A total of 100 patients will be enrolled. The study is divided in two stages. The Stage 1 cohort is the safety cohort where 10 patients will be enrolled. Stage 1 patients receiving two injections of KIO014 at day 0 and at month 3, and will be followed for 12 months post initial injection. The Stage 2 cohort is the performance cohort for 90 patients, and this stage will be randomized controlled and single-blind for the patient. In stage 2, 60 patients will receive an intra-articular injection of KIO014 (test group) and 30 patients will receive an intra-articular injection of Durolane® (control group). Patients will be followed for 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Innovative chitosan-based biomaterial intended for intraarticular injection.
Crosslinked hyaluronic acid-based biomaterial intended for intraarticular injection.
Safety using 4-point numerical rating scale for local effects
At each visit, the treatment knee is assessed for the occurrence of local effects (joint pain, effusion or swelling) using a 4-point numerical rating scale (NRS) graded 0-3 (none, mild, moderate or severe).
Time frame: All time points for up to 12 months
Change in pain at 3 months versus pre-injection baseline using the 5-graded Likert self-administered WOMAC pain questionnaire (Stage 2 cohort only)
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered questionnaire designed to assess pain, stiffness, and physical function through a series of 24 questions divided into 3 subscales. The WOMAC pain score consists of 5 questions. Each question is graded 0-4 on the 5-graded Likert scale (none, mild, moderate, severe or extreme) relating to how much pain the subject has experienced during the last 48 hours. The mean score is reported.
Time frame: 3 months
Changes from baseline in total score, pain, stiffness, and physical functioning subscales of the treatment knee as measured using the 5-graded Likert WOMAC at the different time points over 6 months.
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered questionnaire designed to assess pain, stiffness, and physical function through a series of 24 questions divided into 3 subscales. Each question is graded 0-4 on the 5-graded Likert scale (none, mild, moderate, severe or extreme) relating to how much pain, stiffness or daily physical activities the subject has experienced during the last 48 hours. The score of each dimension, namely pain, stiffness and physical function, is calculated by simply adding the score for each question using the 5-graded Likert scale from 0 to 4. For each dimension, the mean score is reported.
Time frame: 6 months
Changes from baseline in subject's pain using an 11-point Numerical Rating Scale (NRS) at the different time points over 6 months.
Pain at rest is evaluated using a self-administered 11-point numerical rating scale (NRS) from "no pain = 0" to "worst pain = 10". Subject's pain can be used as a criterion for evaluating the OMERACT-OARSI responders.
Time frame: 6 months
Changes from baseline in subject's global assessment using an 11-point Numerical Rating Scale (NRS) at the different time points over 6 months.
Subject's global assessment is evaluated using a self-administered 11-point numerical rating scale (NRS) from "very poor = 0" to "excellent = 10". Subject's global assessment can be used as a criterion for evaluating the OMERACT-OARSI responders.
Time frame: 6 months
Response to treatment according to Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OMERACT) at the different time points over 6 months.
The proportion of subjects meeting the OMERACT criteria for the response to treatment from the Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OMERACT).
Time frame: 6 months
Treatment responders with >40% improvement in pre-injection pain (WOMAC Likert) at the different time points over 6 months.
The proportion of subjects with a 40% improvement in pre-injection pain as evaluated by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score using the 5-graded Likert scale from 0 to 4 (none, mild, moderate, severe or extreme) relating to how much pain the patient has experienced during the last 48 hours.
Time frame: 6 months
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