Safety of NStride Autologous Protein Solution in the Treatment of Knee Osteoarthritis (PROGRESS I)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02262364|
Recruitment Status : Completed
First Posted : October 13, 2014
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Biological: APS||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of a Single Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: NStride APS
Subjects will receive an intra-articular injection of APS.
- Adverse Events [ Time Frame: 1 Year ]Adverse Events and Serious Adverse Events
- Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire [ Time Frame: 12 months ]
The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation.
The WOMAC pain subscale consists of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain).
The WOMAC stiffness subscale consists of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness).
The WOMAC physical function subscale consists of seventeen questions scored from 0 to 4. The physical function score has a range of 0 (no functional limitation) to 68 (maximal functional limitation).
- Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS) [ Time Frame: 12 months ]The Numeric Rating Scale (NRS) is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 "no pain" and 10 "worst possible pain". Subjects rate their average pain over the last 24 hours.
- Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 12 months ]
The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. 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). The previous week is used as the time period for answering the questions.
A higher score on the KOOS questionnaire indicates fewer problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262364
|United States, Indiana|
|Orthopedic and Sports Medicine Center of Northern Indiana (OSMC)|
|Elkhart, Indiana, United States, 46550|
|Principal Investigator:||Mark Klaassen||OSMC|