Biomet nSTRIDE
Research type
Research Study
Full title
Prospective Post-Market Data Collection on Patients with Knee Osteoarthritis and Treated with nSTRIDE Autologous Protein Solution (PROGRESS III)
IRAS ID
182388
Contact name
Vikas Vedi
Contact email
Sponsor organisation
Zimmer Biomet Biologics
Duration of Study in the UK
years, months, days
Research summary
The study is a multi-center, prospective, longitudinal case series design. This design will produce Level IV data.
Patents with symptomatic unilateral knee osteoarthritis or bilateral knee osteoarthritis if both knees are eligible for treatment.
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.
The nSTRIDE Autologous Protein Solution (APS) Kit with ACD-A aids separation of the patient’s own blood components by density through the use of a Biomet Biologics centrifuge. The nSTRIDE Autologous Protein Solution (APS) Kit with ACD-A permits autologous protein solution (APS) to be rapidly prepared from a small volume of the patient’s blood that is drawn at the time of treatment.
Patients will be followed until they receive an intrusive treatment other than
nSTRIDE APS.REC name
London - City & East Research Ethics Committee
REC reference
15/LO/1524
Date of REC Opinion
25 Nov 2015
REC opinion
Further Information Favourable Opinion