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

Osteoarthritis, Knee Clinical Trial

— PROGRESS III  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580643
• Other study ID #: BBIO.CRNSAPS002.15
• Status: Completed
• Start date: May 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• APS
intra-articular injection

Locations

Country	Name	City	State
United Kingdom	BMI Bishops Wood Hospital	Northwood

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment.		Through 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Procedural complications and adverse events		Through 12 months