Trial Outcomes & Findings for Safety of NStride Autologous Protein Solution in the Treatment of Knee Osteoarthritis (PROGRESS I) (NCT NCT02262364)

NCT ID: NCT02262364

Last Updated: 2019-02-15

Results Overview

Adverse Events and Serious Adverse Events

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 11 participants
• Primary outcome timeframe: 1 Year
• Results posted on: 2019-02-15

Participant Flow

Participant milestones

Measure	NStride APS Subjects will receive an intra-articular injection of APS.
Study Enrollment STARTED	11
Study Enrollment COMPLETED	11
Study Enrollment NOT COMPLETED	0
Blood Draw for Device Processing STARTED	11
Blood Draw for Device Processing COMPLETED	10
Blood Draw for Device Processing NOT COMPLETED	1
Injection With APS STARTED	10
Injection With APS COMPLETED	10
Injection With APS NOT COMPLETED	0
Follow-Up Through 12 Months STARTED	10
Follow-Up Through 12 Months COMPLETED	10
Follow-Up Through 12 Months NOT COMPLETED	0

Reasons for withdrawal

Measure	NStride APS Subjects will receive an intra-articular injection of APS.
Blood Draw for Device Processing Insufficient blood could be drawn	1

Baseline Characteristics

Safety of NStride Autologous Protein Solution in the Treatment of Knee Osteoarthritis (PROGRESS I)

Baseline characteristics by cohort

Measure	NStride APS n=10 Participants Subjects will receive an intra-articular injection of APS.
Age, Customized Mean Patient Age	58.8 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year

Adverse Events and Serious Adverse Events

Outcome measures

Measure	NStride APS n=10 Participants Subjects will receive an intra-articular injection of APS.
Adverse Events Adverse Events	27 events
Adverse Events Serious Adverse Events	1 events

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	NStride APS n=10 Participants Subjects will receive an intra-articular injection of APS.
Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire WOMAC Physical Function - 12 Months	12.1 units on a scale Standard Deviation 9.8
Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire WOMAC Pain - Baseline	12.2 units on a scale Standard Deviation 1.7
Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire WOMAC Pain - 12 Months	3.3 units on a scale Standard Deviation 2.9
Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire WOMAC Stiffness - Baseline	4.8 units on a scale Standard Deviation 1.4
Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire WOMAC Stiffness - 12 Months	1.6 units on a scale Standard Deviation 1.7
Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire WOMAC Physical Function - Baseline	38.6 units on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	NStride APS n=10 Participants Subjects will receive an intra-articular injection of APS.
Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS) NRS Pain - Baseline	5.9 units on a scale Standard Deviation 1.9
Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS) NRS Pain - 12 Months	1.6 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	NStride APS n=10 Participants Subjects will receive an intra-articular injection of APS.
Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) KOOS Pain - Baseline	36.9 units on a scale Standard Deviation 16.2
Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) KOOS Pain - 1 Week	56.7 units on a scale Standard Deviation 16.5
Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) KOOS Pain - 12 Months	79.7 units on a scale Standard Deviation 16.2

Adverse Events

NStride APS

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	NStride APS n=10 participants at risk Subjects will receive an intra-articular injection of APS.
Gastrointestinal disorders Diverticulitis	10.0% 1/10

Other adverse events

Measure	NStride APS n=10 participants at risk Subjects will receive an intra-articular injection of APS.
Musculoskeletal and connective tissue disorders Pain in extremity	30.0% 3/10
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10
Musculoskeletal and connective tissue disorders Muscle spasms	10.0% 1/10
Cardiac disorders Hypertension	10.0% 1/10
General disorders Gingival swelling	10.0% 1/10
Respiratory, thoracic and mediastinal disorders Wheezing	10.0% 1/10
Musculoskeletal and connective tissue disorders Joint stiffness	10.0% 1/10
Musculoskeletal and connective tissue disorders Joint swelling	10.0% 1/10
Musculoskeletal and connective tissue disorders Arthralgia	30.0% 3/10
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	10.0% 1/10
Endocrine disorders Blood glucose increased	10.0% 1/10
Musculoskeletal and connective tissue disorders Limb discomfort	10.0% 1/10
Respiratory, thoracic and mediastinal disorders Respiratory disorder	10.0% 1/10
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	10.0% 1/10
Musculoskeletal and connective tissue disorders Foot fracture	10.0% 1/10
General disorders Nasopharyngitis	10.0% 1/10
General disorders Tooth extraction	10.0% 1/10

Additional Information

Jennifer Woodell-May, PhD

Zimmer Biomet

Email: jennifer.woodell-may@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Investigator must provide the Sponsor at least 90 days to review publications for legal and regulatory compliance and will include in publications a statement that the study was supported by the Sponsor. Sponsor confidential information will not be submitted for publication without Sponsor consent. Sponsor may request delay of publication for 60 days to allow for patent application filing.
• Publication restrictions are in place

Restriction type: OTHER