NCT02610192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 2, 2019

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

2.3 years

First QC Date

November 10, 2015

Results QC Date

July 8, 2019

Last Update Submit

June 11, 2020

Conditions

Patellofemoral Osteoarthritis

Keywords

Autologous Protein SolutionPatellofemoral OsteoarthritisFemale

Outcome Measures

Primary Outcomes (1)

  • Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months

    The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems.

    Baseline, 1, 3, 6 and 12 Months

Secondary Outcomes (9)

  • Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months

    Baseline, 1, 3, 6 and 12 Months

  • Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months

    Baseline, 1, 3, 6 and 12 Months

  • Function in Sport and Recreation (Sport/Rec) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Sport/Rec at 1, 3, 6 and 12 Months

    Baseline, 1, 3, 6 and 12 Months

  • Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months

    Baseline, 1, 3, 6 and 12 Months

  • Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months

    Baseline, 1, 3, 6 and 12 Months

  • +4 more secondary outcomes

Interventions

nSTRIDE Autologous Protein Solution (APS) KitDEVICE

Intra-articular injection of APS

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Monica

Deurne, Belgium

Location

Results Point of Contact

Title
Mr. Cahit Akbas
Organization
Zimmer Biomet
Cahit.Akbas@zimmerbiomet.com
+31622981737

Study Officials

  • Peter Verdonk, MD

    AZ Monica, Deurne

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 20, 2015

Study Start

March 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 12, 2020

Results First Posted

December 2, 2019

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)