nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis

NCT ID: NCT02610192

Last Updated: 2020-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-06-30

Brief Summary

The purpose of this study is to evaluate clinical outcomes following a single injection of nSTRIDE Autologous Protein Solution in females with isolated patellofemoral osteoarthritis. A secondary objective of this study is to document the duration of treatment effect following nSTRIDE injection.

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. Thus, making generalizations regarding the effectiveness across these autologous therapies is more complicated. 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 pilot trial. Further, demonstration of the treatment effects in patellofemoral osteoarthritis, an important subset of knee osteoarthritis is lacking. This study will evaluate a population of female patients with patellofemoral osteoarthritis in which treatment with other modalities provides limited/short lived relief with the hope that APS treatment will provide and extend relief to these patients. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following a single injection (per symptomatic knee).

Conditions

Patellofemoral Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

nSTRIDE Autologous Protein Solution (APS) Kit

Intra-articular injection of APS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient must be female
• Isolated patellofemoral osteoarthritis (PFOA) in one or both knees as diagnosed by the treating physician
• Objective evidence of PFOA on one or both of a radiograph or MRI taken within 3 months of treatment
• From 40-65 years of age, inclusive at time of injection
• Symptoms return such that there is a need for further treatment within 3 months of a corticosteroid or hyaluronic acid injection
• Willing and able to comply with the study procedures
• Sign informed consent form

Exclusion Criteria

• Any systematic inflammatory condition (e.g. rheumatoid arthritis)
• Active malignancy at time of injection
• Pregnant at time of injection
• Lactating at 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
• Participation in another device, biologic or drug study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Verdonk, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Monica, Deurne

Locations

AZ Monica

Deurne, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

APSS-55-00

Identifier Type: OTHER

Identifier Source: secondary_id

BBIO.CR.APSPFO.001.15

Identifier Type: -

Identifier Source: org_study_id