nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

NCT03182374 | Completed Results

• 1 other identifier: APSS-66-00
• Study Type: interventional
• Target: 252
• Locations: 10 countries
• Sites: 14

Brief Summary

This is a two-phase multicenter, double-blind, randomized, prospective evaluation of intra-articular injection(s) comparing APS to intra-articular HA injection(s). The maximum study duration for each subject will be 50 months; 48 months from treatment to last follow-up, and two additional months if the maximum visit window is realized. A total of 246 patients will be enrolled. These patients will meet specific inclusion and exclusion criteria, but can be generally characterized as patients with painful unilateral knee OA who have been unable to achieve satisfactory pain relief with previous conservative OA treatment.

Conditions

Osteoarthritis, Knee

Keywords

Autologous Protein Solution (APS); Intra-articular Injection; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to 12 Months Post-injection in Mean WOMAC LK3.1 Pain Score in Both Arms of the Study (nSTRIDE APS and Synvisc One)

  The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5), stiffness (2), and physical function (17). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. 0 represents the best health status and 96 the worst possible status. This section will only analyze the WOMAC pain score.

  12 months

Secondary Outcomes (5)

• Change From Baseline to 12 Months Post-injection in Mean NRS Pain Scale in Both Arms of the Study (nSTRIDE APS and Synvisc One)

  12 months

• Number or Participants Achieving Clinical Success as Defined by OMERACT-OARSI Responder Criteria in Both Arms of the Study (nSTRIDE APS and Synvisc One)

  12 months

• Change From Baseline to 12 Months Post-injection in Mean WOMAC LK 3.1 Function Subscale in Both Arms of the Study (nSTRIDE APS and Synvisc One)

  12 months

• Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - VAS Score

  12 months

• Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - Health Status Score

  12 months

Study Arms (2)

nSTRIDE APS

ACTIVE COMPARATOR

The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms.

Device: nSTRIDE APS

Synvisc-One

ACTIVE COMPARATOR

Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee

Device: Synvisc-One

Interventions

nSTRIDE APS DEVICE

Intra-articular injection

Also known as: Autologous Protein Solution

nSTRIDE APS

Synvisc-One DEVICE

Intra-articular injection

Also known as: hylan G-F 20

Synvisc-One

Eligibility Criteria

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

You may qualify if:

• Male or female at least 18 years of age at time of screening.
• Willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions.
• A standing knee radiograph showing a K-L grade of 2 to 4
• Body mass index ≤ 40 kg/m2
• A qualifying WOMAC LK 3.1 pain subscale total score
• Signed an ethics committee-reviewed and approved informed consent form.

You may not qualify if:

• Presence of clinically observed active infection in the index knee
• Presence of symptomatic OA in the non-study knee at screening
• Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis
• Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
• Presence of venous or lymphatic stasis in the index leg
• A history of local anesthetic allergy
• Previously documented failed treatment with nSTRIDE APS or Synvisc One

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (14)

AZ Monica

Antwerp, Belgium

Location

The Parker Institute, Frederiksberg Hospital

Copenhagen, Denmark

Location

Praxiskliniek für Unfallchirurgie und Orthopädie

Eisenach, Germany

Location

KniePraxis

Straubing, Germany

Location

Rizzoli Orthopedic Institute

Bologna, Italy

Location

The Istituto Clinico Humanitas

Milan, Italy

Location

Maastricht UMC+

Maastricht, Netherlands

Location

Oslo University Hospital - Olympiatoppen

Oslo, Norway

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

Location

Ospedale Regionale di Lugano

Lugano, Switzerland

Location

Yildirim Beyazit University, School of Medicine

Ankara, Turkey (Türkiye)

Location

Gloucestershire Hospitals NHS Foundation Trust

Cheltenham, United Kingdom

Location

Royal Infirmary of Edinburgh - NHS Lothian

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Clinical Project Lead
• Organization: Zimmer Biomet

miguelcorreatapia@zimmerbiomet.com

+41791522905

Study Officials

• Elizaveta Kon

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study where subjects and evaluators are blinded to treatment up to 12-months. During the long-term follow-up phase (12 - 48 months), only subjects will be blinded to the study treatment resulting in single-blind design following 12-month follow-up time point.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: During the long-term follow-up phase (12 - 48 months), subjects may also elect to cross over to the other treatment arm and receive additional injections of the other treatment as frequently as needed, provided they did not experience any significant clinical concerns after previous treatment administrations and are benefiting from it, as determined by the investigator. Subjects may only cross over from their originally assigned treatment group to the other treatment group one time during the study.

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 9, 2017
• Study Start: July 14, 2017
• Primary Completion: September 30, 2019
• Study Completion: January 30, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1); BE (1); DK (1); NL (1); CH (1); NO (1); DE (2); GB (2); IT (2); ES (2)