Clinical trial NCT03182374: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Autologous Protein Solution (APS)
Intra-articular Injection
Osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-06-09
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: 12 months
Secondary outcomes:
measure: Change From Baseline to 12 Months Post-injection in Mean NRS Pain Scale in Both Arms of the Study (nSTRIDE APS and Synvisc One)
timeFrame: 12 months
measure: Number or Participants Achieving Clinical Success as Defined by OMERACT-OARSI Responder Criteria in Both Arms of the Study (nSTRIDE APS and Synvisc One)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: AZ Monica
city: Copenhagen
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
city: Eisenach
country: Germany
facility: Praxiskliniek für Unfallchirurgie und Orthopädie
city: Straubing
country: Germany
facility: KniePraxis
city: Bologna
country: Italy
facility: Rizzoli Orthopedic Institute
city: Milano
country: Italy
facility: The Istituto Clinico Humanitas
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Oslo
country: Norway
facility: Oslo University Hospital - Olympiatoppen
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Ankara
country: Turkey
facility: Yildirim Beyazit University, School of Medicine
city: Cheltenham
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh - NHS Lothian
Study officials:
affiliation: Humanitas University Hospital
name: Elizaveta Kon
role: PRINCIPAL_INVESTIGATOR
References: