Prospective Post-Market Data Collection on Patients With Knee OA and Treated With nSTRIDE APS (PROGRESS III)

Prospective Post-Market Data Collection on Patients With Knee Osteoarthritis and Treated With nSTRIDE Autologous Protein Solution (REGP-22-00)

This study will document treatment effects, changes in quality of life, procedure complications, adverse events, healthcare resource utilization, and further needed intervention(s) following treatment with nSTRIDE autologous protein solution. This study will also allow for the documentation of the same parameters following multiple injections of autologous protein solution to treat knee osteoarthritis.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Biological: APS

Detailed Description

Clinical trials have, in general, formally demonstrated the effectiveness and safety of various autologous therapies for the treatment of knee OA. Differences in the processing of autologous therapies can yield substantial differences in the resulting output. It appears that the safety of autologous therapies is roughly equivalent across different processing methods. However, making generalizations regarding the effectiveness across these autologous therapies is more complicated. Thus, each autologous therapy requires independent efficacy evaluation. nSTRIDE APS has been shown to decrease pain, increase function and have a favorable safety profile in a small pilot trial. However, demonstration of the treatment effects in a more heterogeneous population is lacking. Further, neither the effect time course nor the utility of multiple injections has been documented. This study will allow for low burden, efficient data collection in a larger heterogeneous population of persons suffering from knee OA. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following single or repeated injections.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• United Kingdom
  • Northwood, United Kingdom, HA6 2JW
    • BMI Bishops Wood Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with bilateral or unilateral knee OA will be prospectively enrolled in the study.

Description

Inclusion Criteria:

• OA of one or both knees as diagnosed by the treating physician
• At least 18 years of age
• Willing and able to comply with the study procedures
• Signed informed consent form

Exclusion Criteria:

• Any systemic inflammatory condition ( e.g., rheumatoid arthritis)
• Active malignancy at time of injection
• Pregnant at time of injection
• Lactating at the time of injection
• Knee joint infections or skin diseases or infections in the area of the injection site.
• Leukemia, metastatic malignant cells, or who are receiving chemotherapeutic treatment
• Participating in another device or drug study

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
APS Injection; Autologous Protein Solution	Biological: APS; intra-articular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee pain and function	Quantify and characterize the percentage of OMERACT-OARSI high improvement in pain responders at all post-injection time points. OMERACT-OARSI high improvement in pain responders are defined as subjects who show a 50% improvement in the KOOS pain sub-scale score and an absolute improvement of at least 20 points on the KOOS pain subscale score.	Through 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment.		Through 12 months
Numeric Rating Scales (NRS)	Quantify the change in knee pain, stiffness and function	Evaluated at 2 and 4 weeks and 3, 6 and 12 months
European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L)	Quantify the change in quality of life	Evaluated at 2 and 4 weeks and 3, 6 and 12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Quantify changes in pain, symptoms, activities of daily life, engagement in sports and recreation and quality of living	Evaluated at 2 and 4 weeks and 3, 6 and 12 months
Procedural complications and adverse events		Through 12 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis; Intra-articular Injection; Autologous Protein Solution
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: BBIO.CRNSAPS002.15