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

NCT ID: NCT02580643

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-06-30

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.

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.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

APS Injection

Autologous Protein Solution

APS

Intervention Type: BIOLOGICAL

intra-articular injection

Interventions

APS

intra-articular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BMI Bishops Wood Hospital

Northwood, , United Kingdom

Countries

United Kingdom

Other Identifiers

BBIO.CRNSAPS002.15

Identifier Type: -

Identifier Source: org_study_id