Trial Outcomes & Findings for nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis (NCT NCT03182374)

Last Updated: 2024-09-19

Results Overview

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5), stiffness (2), and physical function (17). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. 0 represents the best health status and 96 the worst possible status. This section will only analyze the WOMAC pain score.

Recruitment status

COMPLETED

Study phase

Target enrollment

252 participants

Primary outcome timeframe

12 months

Results posted on

2024-09-19

Participant Flow

The clinical investigation began on 25 July 2017 when the first subject received treatment. Subject recruitment was completed on 20 September 2018, when the last subject was randomized and received injection.

Subjects giving written informed consent underwent screening assessments including demographics, medical history, physical examination, knee examination, a urine pregnancy test (if applicable) and the WOMAC LK 3.1. Upon confirmation of eligibility, subjects were scheduled for a treatment visit, and a baseline X-ray and MRI were performed.

Participant milestones

Participant milestones
Measure	nSTRIDE APS The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One Synvisc-One is intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection
Overall Study STARTED	125	127
Overall Study Treated	124	127
Overall Study 12-month Follow-up	111	106
Overall Study COMPLETED	111	106
Overall Study NOT COMPLETED	14	21

Reasons for withdrawal

Reasons for withdrawal
Measure	nSTRIDE APS The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One Synvisc-One is intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection
Overall Study Lost to Follow-up	3	2
Overall Study Lack of Efficacy	8	14
Overall Study Withdrawal by Subject	1	1
Overall Study exit for non-compliance	1	1
Overall Study one subject was randomized but not treated	1	0
Overall Study Other reasons	0	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	nSTRIDE APS n=125 Participants The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One n=127 Participants Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection	Total n=252 Participants Total of all reporting groups
Age, Continuous	58.9 years STANDARD_DEVIATION 10.52 • n=125 Participants	57.9 years STANDARD_DEVIATION 10.82 • n=127 Participants	58.9 years STANDARD_DEVIATION 10.5 • n=252 Participants
Sex: Female, Male Female	75 Participants n=125 Participants	78 Participants n=127 Participants	153 Participants n=252 Participants
Sex: Female, Male Male	50 Participants n=125 Participants	49 Participants n=127 Participants	99 Participants n=252 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	28.20 kg/m^2 STANDARD_DEVIATION 4.211 • n=125 Participants	27.53 kg/m^2 STANDARD_DEVIATION 4.217 • n=127 Participants	27.86 kg/m^2 STANDARD_DEVIATION 4.214 • n=252 Participants

PRIMARY outcome

Timeframe: 12 months

Population: ITT population, with imputations for missing data

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=125 Participants The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One n=127 Participants Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection
Change From Baseline to 12 Months Post-injection in Mean WOMAC LK3.1 Pain Score in Both Arms of the Study (nSTRIDE APS and Synvisc One) Baseline	11.5 score on a scale Standard Deviation 2.36	11.9 score on a scale Standard Deviation 2.45
Change From Baseline to 12 Months Post-injection in Mean WOMAC LK3.1 Pain Score in Both Arms of the Study (nSTRIDE APS and Synvisc One) 12 month Follow-up	6.7 score on a scale Standard Deviation 3.93	7.2 score on a scale Standard Deviation 4.26

SECONDARY outcome

Timeframe: 12 months

Population: PP Population

In a Numerical Rating Scale (NRS) pain scale, patients are asked to circle (in an horizontal bar or line) the number between 0 and 10 that fits best to their average pain intensity. 0 = No pain at all; 5 = Moderate pain; 10 = Worst possible pain

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=102 Participants The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One n=98 Participants Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection
Change From Baseline to 12 Months Post-injection in Mean NRS Pain Scale in Both Arms of the Study (nSTRIDE APS and Synvisc One) Baseline	5.8 score on a scale Standard Deviation 2.0	6.2 score on a scale Standard Deviation 1.8
Change From Baseline to 12 Months Post-injection in Mean NRS Pain Scale in Both Arms of the Study (nSTRIDE APS and Synvisc One) 12 month follow-up	4.0 score on a scale Standard Deviation 2.53	4.4 score on a scale Standard Deviation 2.51

SECONDARY outcome

Timeframe: 12 months

The Outcome Measures in Rheumatology workgroup (OMERACT), together with the Osteoarthritis Research Society International (OARSI) developed the OMERACT-OARSI responder criteria. These criteria are used to determine if a patient with osteoarthritis (OA) 'responds' to therapy, meaning experiences a clinically relevant effect of therapy. It includes three symptomatic domains (pain, function, and patient's global assessment). To the question: High improvement in pain or in function (≥50%) and absolute change ≥20%, a positive answer is understood as "Response". A negative answer leads to an additional analysis, which seeks improvement in at least 2 of the 3 following: 1. pain ≥20% and absolute change ≥10; 2. function ≥20% and absolute change ≥10; 3. patient's global assessment ≥20% and absolute change ≥10. A positive answer here is understood as "Response". A negative answer is a "No response"

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=102 Participants The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One n=98 Participants Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection
Number or Participants Achieving Clinical Success as Defined by OMERACT-OARSI Responder Criteria in Both Arms of the Study (nSTRIDE APS and Synvisc One) Responder	60 Participants	61 Participants
Number or Participants Achieving Clinical Success as Defined by OMERACT-OARSI Responder Criteria in Both Arms of the Study (nSTRIDE APS and Synvisc One) Non-responder	42 Participants	37 Participants

SECONDARY outcome

Timeframe: 12 months

Population: MCID Function Responder analysis

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=102 Participants The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One n=98 Participants Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection
Change From Baseline to 12 Months Post-injection in Mean WOMAC LK 3.1 Function Subscale in Both Arms of the Study (nSTRIDE APS and Synvisc One) Baseline	35.4 score on a scale Standard Deviation 11.47	39.5 score on a scale Standard Deviation 11.60
Change From Baseline to 12 Months Post-injection in Mean WOMAC LK 3.1 Function Subscale in Both Arms of the Study (nSTRIDE APS and Synvisc One) 12 month follow-up	20.5 score on a scale Standard Deviation 13.46	23.0 score on a scale Standard Deviation 14.62

SECONDARY outcome

Timeframe: 12 months

The EurpoQol five-dimensional (EQ-5D) is a standardized instrument for measuring the health-related quality of life. Part of the Eq-5Q questionnaire consist of a visual analogue score (VAS), a vertical calibrated line, on which a patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). Respondents indicate where they perceive their present state of health to lie, relative to these anchors.

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=102 Participants The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One n=98 Participants Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection
Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - VAS Score Baseline	68.7 score on a scale Standard Deviation 16.92	68.0 score on a scale Standard Deviation 16.88
Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - VAS Score 12 month follow-up	73.4 score on a scale Standard Deviation 16.02	71.7 score on a scale Standard Deviation 16.80

SECONDARY outcome

Timeframe: 12 months

Population: patients lost during follow-up

The EurpoQol five-dimensional (EQ-5D), section Health Status, is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety depression. Each question has five levels of response (no problem, slight problem, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score. The health status ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher score indicating higher health utility.

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=102 Participants The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One n=98 Participants Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection
Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - Health Status Score Baseline	0.6 score on a scale Standard Deviation 0.27	0.6 score on a scale Standard Deviation 0.27
Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - Health Status Score 12 month follow-up	0.7 score on a scale Standard Deviation 0.20	0.7 score on a scale Standard Deviation 0.24

Adverse Events

nSTRIDE APS

Serious events: 8 serious events

Other events: 34 other events

Deaths: 0 deaths

Synvisc-One

Serious events: 9 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	nSTRIDE APS n=124 participants at risk The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One n=127 participants at risk Synvisc-One is intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection
General disorders Injection site swelling	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
General disorders Vessel puncture site bruise	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Infections and infestations Arthritis bacterial	0.00% 0/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.79% 1/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Injury, poisoning and procedural complications Injection site pain	6.5% 8/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	3.1% 4/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Arthralgia	7.3% 9/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	8.7% 11/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Joint stiffness	3.2% 4/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Joint swelling	8.1% 10/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	3.1% 4/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Surgical and medical procedures Venipuncture	0.00% 0/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.79% 1/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.

Additional Information

Clinical Project Lead

Zimmer Biomet

Phone: +41791522905

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	nSTRIDE APS n=124 participants at risk The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection	Synvisc-One n=127 participants at risk Synvisc-One is intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	1.6% 2/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Hepatobiliary disorders Biliary colic	0.00% 0/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.79% 1/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Medial Meniscus Lesion+Cartilage Lesion at Medial Femoral Condyle Left Knee	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Reproductive system and breast disorders Uterine prolapse	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Wrist affected	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Biceps tendon rupture right arm	0.00% 0/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.79% 1/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Gastrointestinal disorders Accute appendicitis	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Infection index knee	0.00% 0/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.79% 1/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Excessive swelling of Index Knee	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Blood and lymphatic system disorders Hypercalcemia	0.00% 0/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.79% 1/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Skin and subcutaneous tissue disorders Actinic and Seborhoeic Keratosis in scalp and right ear	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Hospital admission for gout in left (non index knee)	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Worsening of arthrosis left (non index) knee	0.81% 1/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.00% 0/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Reproductive system and breast disorders gyneacological operation myom ovaries benigne	0.00% 0/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.79% 1/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Musculoskeletal and connective tissue disorders Excessive pain of index knee	0.00% 0/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.79% 1/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
Renal and urinary disorders Ureteral colic (kidney stones)	0.00% 0/124 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.	0.79% 1/127 • During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.