Comparative Study of Two Hyaluronic Acid Formulation in the Management of Knee Osteoarthritis

NCT06528600 | Completed

• 1 other identifier: EQE9-18-01
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 19

Brief Summary

The objective of this randomized, double-blind, active-controlled, non-inferiority study is to compare the effectiveness and safety of a single injection of Hymovis ONE®, a sodium hyaluronate formulation, to Monovisc™, another sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens. This study consists of a 2-week period for screening, one baseline treatment visit, and a 26- week evaluation phase. Subjects will be randomized to receive a single intra-articular (IA) injection of either Hymovis ONE® or Monovisc™ into the knee using an 18-20 gauge needle.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Pain relief compared to baseline

  Change From Baseline (CFB) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK3.1 A1 Pain subscale (walking on a flat surface) score

  week 12

Secondary Outcomes (9)

• Patient respons to treatment

  Week 12 and 26

• Pain relief compared to baseline

  Week 26

• Joint Stiffness compared to baseline

  Week 26

• Joint Function compared to baseline

  Week 26

• Patient quality of life

  Weeks 4,12 and 26

Study Arms (2)

Hymovis One

EXPERIMENTAL

Treatment with 4 mL of Hymovis ONE® in the Intra-articular space

Device: Hymovis ONE

Monovisc

ACTIVE COMPARATOR

Treatment with 4 mL of Monovisc™ in the Intra-articular space

Device: Monovisc

Interventions

Hymovis ONE DEVICE

Single injection of Hymovis ONE®, a sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens

Hymovis One

Monovisc DEVICE

Single injection of Monovisc™ a sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens

Monovisc

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male subjects ≥ 40 and ≤ 75 years of age
• Body mass index (BMI) ≥20 and \<35 kg/m2
• Tegner score ≥3
• Subjects with primary knee OA of the medial or lateral femorotibial compartment with symptoms at screening and for at least 3 months prior to screening according to American College of Rheumatology (ACR) criteria and who have not responded to conservative non-pharmacologic treatment or simple analgesic regimens
• Subjects with Kellgren-Lawrence (K-L) radiological grade 2 or 3 in the target knee
• Subjects with at least one X-Ray image of the target knee taken at screening or within 6 months prior to the screening.
• Subjects with OA pain intensity meeting the criteria below:
• Subjects demonstrating at both the screening (V0) and the baseline (V1) visit, pain intensity in the target knee of 2 - 3 and in the contralateral knee 0 as measured by the WOMAC LK3.1 A1 Pain subscale (walking on a flat surface)
• Willingness to discontinue oral and topical analgesics including NSAIDs and accept "rescue" paracetamol as the only medicine for joint pain prior to the injection and throughout the study. "Rescue" medication will be discontinued 24 hours before any study visit
• Subjects able to understand and willing and able to comply with study procedures
• Subjects able to provide informed consent
• If female of childbearing potential, must have a negative pregnancy test at screening and agree to use a reliable form of contraception throughout the study\*.
• Note: To be considered of non-childbearing potential, females must be surgically sterile or postmenopausal for at least 1 year.
• \*Highly effective birth control methods include: combined hormonal contraception containing estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine ormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.

You may not qualify if:

• Inability to perform a 50-foot walk test
• Subjects with secondary (post-traumatic) knee OA of the target joint
• Subjects with K-L radiological grade 1 or 4 in the target knee
• Subjects with known X-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and /or severe bone or joint deformity in the target knee
• Clinically apparent tense effusion of the target knee on examination (determined by either a positive bulge sign or ballottement of the patella (patellar tap))
• Subjects with osteonecrosis of either knee
• Subjects with a history of knee joint replacement or arthroplasty of the target knee
• Subjects with a history of arthroscopy of the target knee in the past 6 months
• Subjects with a history of osteotomy or surgery of the target or contralateral knee and any other weight-bearing joint that would have interfered with knee assessment
• Subjects with acute, recurrent synovitis, or any inflammatory conditions in the target knee
• Subjects with any significant injury to the target knee in the last 6 months (as per Investigator judgment)
• Subjects with any musculoskeletal condition affecting the target knee that would impair the proper assessment of the
• Investigational Medical Device (IMD) performance in the target knee as assessed by the Investigator such as:
• severe varus/valgus deformity (\>15°)
• predominantly patellofemoral pain syndrome

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (19)

Fondazione Poliambulanza , Istituto Ospedaliero UO di Ortopedia e Traumatologia

Brescia, BS, 25124, Italy

Location

ASST Valcamonica U.O.C. Ortopedia

Esine, BS, 25040, Italy

Location

A.O.R.N. S. Anna e S. Sebastiano U.O.C. Ortopedia e Traumatologia

Caserta, CE, 81100, Italy

Location

U.O. Ortopedia e Traumatologia Casa di Cura

Maddaloni, CE, 81024, Italy

Location

A.O. Ospedale Santa Croce e Carle S.C. Ortopedia e Traumatologia

Cuneo, CN, 12100, Italy

Location

Ospedale S. Maria Borgo Val di Taro - AUSL Parma U.O. Ortopedia e Traumatologia

Borgo Val di Taro, PR, 43043, Italy

Location

Azienda Ospedaliero-Universitaria di Parma U.O. Clinica Ortopedica

Parma, PR, 43126, Italy

Location

Fondazione IRCCS Policlinico San Matteo Pavia U.O.C. Ortopedia e Traumatologia

Pavia, PV, 27100, Italy

Location

Policlinico universitario Campus Biomedico

Roma, RO, 00128, Italy

Location

Ospedale San Giovanni Calibita Fatebenefratelli - Isola Tiberina U.O.C. di Ortopedia e Traumatologia

Roma, RO, 00186, Italy

Location

Ospedale Santo Spirito in Sassia - ASL Roma 1 Ortopedia e Traumatologia

Roma, RO, 00193, Italy

Location

A.O. Città della Salute e della Scienza - Presidio CTO (Centro Traumatologico Ortopedico) S.C. Ortopedia e Traumatologia 1 U

Torino, TO, 10126, Italy

Location

AOU Città della Salute e della Scienza di Torino -Ospedale Molinette S.C. Medicina Fisica e Riabilitazione U Dip. Ortopedia Traumatologia e Riabilitazione

Torino, TO, 10126, Italy

Location

Presidio Sanitario Ospedale Cottolengo Ortopedia

Torino, TO, 10126, Italy

Location

Azienda ULSS 2 Marca Trevigiana - Ospedale di Conegliano U.O.C. Ortopedia e Traumatologia

Conegliano, TV, 31015, Italy

Location

A.O. Ospedale Cardarelli I Ortopedia

Napoli, 80131, Italy

Location

AOU Federico II Napoli UOC Ortopedia e Traumatologia

Napoli, 80131, Italy

Location

P.O. Ospedale del Mare ASL 1 Napoli U.O.C. Ortopedia

Napoli, 80131, Italy

Location

A.O.U. " Maggiore della Carità" S.C. di Ortopedia e Traumatologia

Novara, 28100, 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, randomized (1:1 allocation Hymovis ONE®: Monovisc™), double-blind, active comparator-controlled, non-inferiority study

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: July 30, 2024
• Study Start: September 16, 2020
• Primary Completion: March 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (19)