Prospective Post-Market Data Collection on Patients With Knee OA and Treated With nSTRIDE APS

NCT02580643 | Completed

• 1 other identifier: BBIO.CRNSAPS002.15
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

Autologous Protein Solution; Osteoarthritis; Intra-articular Injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment.

  Through 12 months

• Numeric Rating Scales (NRS)

  Evaluated at 2 and 4 weeks and 3, 6 and 12 months

• European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L)

  Evaluated at 2 and 4 weeks and 3, 6 and 12 months

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Evaluated at 2 and 4 weeks and 3, 6 and 12 months

• Procedural complications and adverse events

  Through 12 months

Study Arms (1)

APS Injection

Autologous Protein Solution

Biological: APS

Interventions

APS BIOLOGICAL

intra-articular injection

APS Injection

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

BMI Bishops Wood Hospital

Northwood, HA6 2JW, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 20, 2015
• Study Start: May 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

GB (1)