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nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
nSTRIDE APS
Synvisc-One
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Autologous Protein Solution (APS), Intra-articular Injection, Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • AZ Monica
  • The Parker Institute, Frederiksberg Hospital
  • Praxiskliniek für Unfallchirurgie und Orthopädie
  • KniePraxis
  • Rizzoli Orthopedic Institute
  • The Istituto Clinico Humanitas
  • Maastricht UMC+
  • Oslo University Hospital - Olympiatoppen
  • Hospital Clínic de Barcelona
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Ospedale Regionale di Lugano
  • Yildirim Beyazit University, School of Medicine
  • Gloucestershire Hospitals NHS Foundation Trust
  • Royal Infirmary of Edinburgh - NHS Lothian

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

nSTRIDE APS

Synvisc-One

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Comparing Autologous Protein Solution (APS) with Hyaluronic Acid (HA) Intra Articular Injections
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 pain score

Secondary Outcome Measures

NRS pain scale
Change in pain as measured by NRS pain scale
OMERACT-OARSI
Percentage of subjects achieving clinical success as defined by OMERACT-OARSI Responder Criteria
WOMAC LK 3.1
Change in WOMAC LK 3.1 function, stiffness subscale and overall scores
EQ-5D
Change in quality of life
Adverse Events (AEs)
Occurrence of AEs

Full Information

First Posted
June 6, 2017
Last Updated
January 21, 2020
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT03182374
Brief Title
nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis
Official Title
A Two-Phase, Multicenter, Randomized Study Comparing Autologous Protein Solution With Hyaluronic Acid Intra Articular Injections in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 14, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 62 months; 60 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Autologous Protein Solution (APS), Intra-articular Injection, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
During the long-term follow-up phase (12 - 60 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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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 - 60 months), only subjects will be blinded to the study treatment resulting in single-blind design following 12-month follow-up time point.
Allocation
Randomized
Enrollment
246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nSTRIDE APS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Synvisc-One
Arm Type
Active Comparator
Arm Description
Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee
Intervention Type
Device
Intervention Name(s)
nSTRIDE APS
Other Intervention Name(s)
Autologous Protein Solution
Intervention Description
Intra-articular injection
Intervention Type
Device
Intervention Name(s)
Synvisc-One
Other Intervention Name(s)
hylan G-F 20
Intervention Description
Intra-articular injection
Primary Outcome Measure Information:
Title
Comparing Autologous Protein Solution (APS) with Hyaluronic Acid (HA) Intra Articular Injections
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 pain score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
NRS pain scale
Description
Change in pain as measured by NRS pain scale
Time Frame
12 months
Title
OMERACT-OARSI
Description
Percentage of subjects achieving clinical success as defined by OMERACT-OARSI Responder Criteria
Time Frame
12 months
Title
WOMAC LK 3.1
Description
Change in WOMAC LK 3.1 function, stiffness subscale and overall scores
Time Frame
12 months
Title
EQ-5D
Description
Change in quality of life
Time Frame
12 months
Title
Adverse Events (AEs)
Description
Occurrence of AEs
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizaveta Kon
Organizational Affiliation
Humanitas University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Monica
City
Antwerp
Country
Belgium
Facility Name
The Parker Institute, Frederiksberg Hospital
City
Copenhagen
Country
Denmark
Facility Name
Praxiskliniek für Unfallchirurgie und Orthopädie
City
Eisenach
Country
Germany
Facility Name
KniePraxis
City
Straubing
Country
Germany
Facility Name
Rizzoli Orthopedic Institute
City
Bologna
Country
Italy
Facility Name
The Istituto Clinico Humanitas
City
Milano
Country
Italy
Facility Name
Maastricht UMC+
City
Maastricht
Country
Netherlands
Facility Name
Oslo University Hospital - Olympiatoppen
City
Oslo
Country
Norway
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
Country
Spain
Facility Name
Ospedale Regionale di Lugano
City
Lugano
Country
Switzerland
Facility Name
Yildirim Beyazit University, School of Medicine
City
Ankara
Country
Turkey
Facility Name
Gloucestershire Hospitals NHS Foundation Trust
City
Cheltenham
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh - NHS Lothian
City
Edinburgh
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

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