Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome

NCT04661111 | Completed

• 1 other identifier: EQL2-15-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy and safety of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteochondral lesions.

Conditions

Knee Osteoarthritis

Keywords

Hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• The efficacy of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteoarthritis due to overuse: KOOS questionnaire (Knee injury and Osteoarthritis Outcome Score)

  To demonstrate that a single intra-articular (i.a.) injection of Hymovis® ONE (32 mg/4 ml) decreases the difficulties in sport and recreational activity. The efficacy will be measured evaluating the improved knee function during sport and recreational activity through the fourth item (SP1-SP5) of the KOOS questionnaire, 90 days after injection. A five-point Likert scale(LK3 series) will be used to score each of the five KOOS questionnaire items (Symptoms, Pain, Function daily living, Function in sports and recreational activities).

  Day 90 after baseline visit

Secondary Outcomes (13)

• Knee function through WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) C scale.

  (Day 0, Day 30, Day 90, Day 180 and Day 360)

• Gait analysis system

  (Day 0, Day 30, Day 90, Day 180)

• Biomechanical kinematic parameters through gait analysis( tilt at heel contact evaluated per each visit reported

  (Day 0, Day 30, Day 90, Day 180)

• Biomechanical kinematic parameters through gait analysis( flexion-evaluated evaluated per each visit reported )

  (Day 0, Day 30, Day 90, Day 180)

• Biomechanical kinematic parameters through gait analysis(rotation RoM evaluated per each visit reported )

  (Day 0, Day 30, Day 90, Day 180)

Study Arms (1)

Hymovis ONE Arm

EXPERIMENTAL

Hymovis® ONE (32 mg/4 ml) intra-articular mono injection. Patients will be followed during 12 months including 6 visits.

Device: Hymovis® ONE (32 mg/4 ml)

Interventions

Hymovis® ONE (32 mg/4 ml) DEVICE

Hymovis® ONE is a clear hydrogel. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process. Hymovis® ONE is a CE-marked Class III Medical Device intended for intra-articular injection.

Hymovis ONE Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female higher than 18 and less or equal to 65 years of age
• an active life-style, professional or regular casual sport player (people who plays sport or trains themselves at least 2-3 times per week).
• diagnosis of knee osteoarthritis will be based upon a standing weight bearing knee X-ray at Screening or an X-ray performed within 6 months prior to screening. The radiograms must be classified as a Kellgren and Lawrence Grade I-III for osteoarthritis of the knee.
• a knee VAS pain score, within 48 hours before the visit.
• patients must have had all analgesic/anti-inflammatory drugs discontinued for 2 weeks prior to Baseline except for acetaminophen.

You may not qualify if:

• Major injury to the contralateral knee or other weight-bearing joint if it would interfere with the study assessments.
• Surgical procedure of the studied joint within the previous 12 months prior to Screening.
• Ligament reconstruction in the target knee within 1 year
• Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis
• Intra-articular or local peri-articular corticosteroid injections to the study joint/knee within the previous 3 months prior to screening or to any other joint (beside the study joint) or soft tissue area within the previous month prior to Screening.
• Any corticosteroid within the previous month. Steroid inhalants are permitted if the patient has been on a stable regimen for the past month prior to Screening and remains on this regimen throughout the course of the trial.
• Intra-articular hyaluronan in the studied joint within the previous 6 months prior to Screening.
• History of allergic reaction to an intra-articular Hyaluronic acid injection
• Use of glucosamine- or chondroitin sulfate-containing products unless the patient is on stable doses for at least 4 months prior to Screening and willing to remain on these stable doses throughout the course of the trial.
• Patients with X-ray findings of acute fractures, severe loss of bone density, avascular necrosis and/or severe deformity.
• Axial deviation of the lower limbs higher than 20 degrees in valgus or varus on standing X-ray.
• Symptomatic osteoarthritis of either hip, contralateral knee or spine that may interfere with functional assessment of the signal knee.
• Clinically significant medio-lateral and/or anterior-posterior instability.
• Osteonecrosis of either knee.
• If patients are receiving or performing physical therapy at Screening, this physical therapy regimen has not been stable during the one-month preceding Screening and the patient is not willing to maintain the same regimen throughout the course of the trial.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (1)

Università di Roma "La Sapienza", Azienda Policlinico Umberto I, Roma

Roma, 00161, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: December 10, 2020
• Study Start: June 13, 2016
• Primary Completion: September 28, 2017
• Study Completion: June 28, 2018
• Last Updated: December 10, 2020

Record last verified: 2020-04

Locations

IT (1)