nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02610192
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Actual Duration (Months): 27
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patellofemoral Osteoarthritis	Device: nSTRIDE Autologous Protein Solution (APS) Kit	N/A

Detailed Description

Clinical trials have, in general, formally demonstrated the effectiveness and safety of various autologous therapies for the treatment of knee OA. Differences in the processing of autologous therapies can yield substantial differences in the resulting output. Thus, making generalizations regarding the effectiveness across these autologous therapies is more complicated. Each autologous therapy requires independent efficacy evaluation. nSTRIDE APS has been shown to decrease pain, increase function and have a favorable safety profile in a pilot trial. Further, demonstration of the treatment effects in patellofemoral osteoarthritis, an important subset of knee osteoarthritis is lacking. This study will evaluate a population of female patients with patellofemoral osteoarthritis in which treatment with other modalities provides limited/short lived relief with the hope that APS treatment will provide and extend relief to these patients. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following a single injection (per symptomatic knee).

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Study of a Single Intra-Articular Injection of Autologous Protein Solution in Females With Primary Patellofemoral Osteoarthritis
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. 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]

   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

2. 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]

   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

3. 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]

   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

4. 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]

   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

5. Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months [Baseline, 1, 3, 6 and 12 Months]

   The NRS is a validated measure of pain, stiffness and function. 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. Likewise subjects rate their stiffness and function on an 11 point Likert type scale

6. Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months [Baseline, 1, 3, 6 and 12 Months]

   The NRS is a validated measure of pain, stiffness and function. 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. Likewise subjects rate their stiffness and function on an 11 point Likert type scale

7. Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months [Baseline, 1, 3, 6 and 12 Months]

   The NRS is a validated measure of pain, stiffness and function. 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. Likewise subjects rate their stiffness and function on an 11 point Likert type scale

8. Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months [Baseline, 1, 3, 6 and 12 Months]

   The KAKPAQ is a 13-item screening instrument designed to assess patellofemoral pain and instability in adolescents and young adults, with a variable ordinal response format (3-5 choices). The questions included knee functional ability; limping, weight bearing, walking, stairs, squatting, running, jumping, prolonged sitting, pain swelling, painful patellar movement, muscle atrophy and flexion deficiency. Each answer had different scores. To calculate the total score, all items were summarized. The score '0' represented the greatest limitation of knee function, whereas the score '100' indicated the ability to perform most knee functions

9. Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months [Baseline, 1, 3, 6 and 12 Months]

   The UCLA Activity Score is a validated measure of subject activity. Subjects rate their current activity level from on a simple scale ranging from 1 to 10. The subject indicated her or his most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Monica	Deurne		Belgium

Sponsors and Collaborators

• Zimmer Biomet

Investigators

• Principal Investigator: Peter Verdonk, MD, AZ Monica, Deurne

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 24, 2016

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT02610192
• Other Study ID Numbers: BBIO.CR.APSPFO.001.15; APSS-55-00
• First Posted: Nov 20, 2015
• Last Update Posted: Jun 12, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Zimmer Biomet: Autologous Protein Solution; Patellofemoral Osteoarthritis; Female
• Additional relevant MeSH terms: Osteoarthritis

Study Results

Participant Flow

Recruitment Details	The study is conducted at a single center in Deurne (Belgium).

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Period Title: Overall Study
STARTED	50
COMPLETED	41
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Overall Participants	50
Age, Customized (years) [Mean (Standard Deviation) ]
Age	50.4 (6.5)
Sex/Gender, Customized (participants) [Number]
Gender (female)	50 100%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Belgium	50 100%

Outcome Measures

1. Primary Outcome

Title	Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months
Description	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.
Time Frame	Baseline, 1, 3, 6 and 12 Months

Outcome Measure Data

Analysis Population Description

Analyses were performed on available data, with no imputation for missing data.

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Measure Participants	50
Baseline	40.3 (18.7)
1-Month	53.5 (19.8)
3-Months	52.5 (24.1)
6-Months	54.9 (22.6)
12-Months	57.3 (24.8)

2. Secondary Outcome

Title	Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months
Description	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
Time Frame	Baseline, 1, 3, 6 and 12 Months

Outcome Measure Data

Analysis Population Description

Analyses were performed on available data, with no imputation for missing data.

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Measure Participants	50
Baseline	46.9 (18.4)
1-Months	59.2 (19.2)
3-Months	61.4 (21.6)
6-Months	61.5 (18.8)
12-Months	62.5 (22.1)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Analyses were performed on available data, with no imputation for missing data.

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Measure Participants	50
Baseline	45.9 (21.1)
1-Months	58.8 (21.9)
3-Months	57.9 (26.8)
6-Months	59.7 (22.8)
12-Months	62.0 (24.2)

4. Secondary Outcome

Title	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
Description	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
Time Frame	Baseline, 1, 3, 6 and 12 Months

Outcome Measure Data

Analysis Population Description

Analyses were performed on available data, with no imputation for missing data.

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Measure Participants	50
Baseline	11.2 (13.6)
1-Months	23.0 (20.1)
3-Months	20.8 (20.2)
6-Months	22.4 (23.7)
12-Months	22.9 (24.3)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Analyses were performed on available data, with no imputation for missing data.

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Measure Participants	50
Baseline	29.7 (10.7)
1-Months	37.5 (12.1)
3-Months	37.0 (11.8)
6-Months	36.3 (13.6)
12-Months	38.2 (13.5)

6. Secondary Outcome

Title	Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months
Description	The NRS is a validated measure of pain, stiffness and function. 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. Likewise subjects rate their stiffness and function on an 11 point Likert type scale
Time Frame	Baseline, 1, 3, 6 and 12 Months

Outcome Measure Data

Analysis Population Description

Analyses were performed on available data, with no imputation for missing data.

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Measure Participants	50
Baseline	6.7 (2.2)
1-Months	4.9 (2.5)
3-Months	5.0 (2.9)
6-Months	4.7 (2.8)
12-Months	4.5 (2.9)

7. Secondary Outcome

Title	Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months
Description	The NRS is a validated measure of pain, stiffness and function. 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. Likewise subjects rate their stiffness and function on an 11 point Likert type scale
Time Frame	Baseline, 1, 3, 6 and 12 Months

Outcome Measure Data

Analysis Population Description

Analyses were performed on available data, with no imputation for missing data.

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Measure Participants	50
Baseline	6.0 (2.6)
1-Months	4.3 (2.8)
3-Months	4.5 (3.1)
6-Months	4.1 (2.8)
12-Months	4.0 (3.1)

8. Secondary Outcome

Title	Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months
Description	The NRS is a validated measure of pain, stiffness and function. 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. Likewise subjects rate their stiffness and function on an 11 point Likert type scale
Time Frame	Baseline, 1, 3, 6 and 12 Months

Outcome Measure Data

Analysis Population Description

Analyses were performed on available data, with no imputation for missing data.

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Measure Participants	50
Baseline	6.6 (2.1)
1-Months	4.9 (2.4)
3-Months	4.7 (2.7)
6-Months	4.7 (2.7)
12-Months	4.4 (2.9)

9. Secondary Outcome

Title	Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months
Description	The KAKPAQ is a 13-item screening instrument designed to assess patellofemoral pain and instability in adolescents and young adults, with a variable ordinal response format (3-5 choices). The questions included knee functional ability; limping, weight bearing, walking, stairs, squatting, running, jumping, prolonged sitting, pain swelling, painful patellar movement, muscle atrophy and flexion deficiency. Each answer had different scores. To calculate the total score, all items were summarized. The score '0' represented the greatest limitation of knee function, whereas the score '100' indicated the ability to perform most knee functions
Time Frame	Baseline, 1, 3, 6 and 12 Months

Outcome Measure Data

Analysis Population Description

Analyses were performed on available data, with no imputation for missing data.

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Measure Participants	50
Baseline	48.4 (13.0)
1-Months	55.4 (16.3)
3-Months	54.8 (17.0)
6-Months	57.0 (17.0)
12-Months	56.3 (18.1)

10. Secondary Outcome

Title	Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months
Description	The UCLA Activity Score is a validated measure of subject activity. Subjects rate their current activity level from on a simple scale ranging from 1 to 10. The subject indicated her or his most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports
Time Frame	Baseline, 1, 3, 6 and 12 Months

Outcome Measure Data

Analysis Population Description

Analyses were performed on available data, with no imputation for missing data.

Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
Measure Participants	50
Baseline	5.0 (1.9)
1-Months	5.3 (1.7)
3-Months	5.5 (2.0)
6-Months	5.2 (1.8)
12-Months	5.6 (1.9)

Adverse Events

Time Frame	month 1, month 3, month 6 and month 12
Adverse Event Reporting Description	Safety analyses was performed on any knee related AEs, procedure and device related AEs only through 12-Month time point. PLEASE NOTE THAT only knee, procedure, and device related Adverse Events were pre-specified to be collected per protocol. All other AEs were not to be collected within this protocol
Arm/Group Title	nSTRIDE APS
Arm/Group Description	Intra-articular Injection of Autologous Protein Solution (APS)
All Cause Mortality
	nSTRIDE APS
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Serious Adverse Events
	nSTRIDE APS
	Affected / at Risk (%)	# Events
Total	3/50 (6%)
Musculoskeletal and connective tissue disorders
Knee Pain	3/50 (6%)	3
Other (Not Including Serious) Adverse Events
	nSTRIDE APS
	Affected / at Risk (%)	# Events
Total	39/50 (78%)
Musculoskeletal and connective tissue disorders
Excessive Injection Site Pain	3/50 (6%)	3
Increased Knee Pain	30/50 (60%)	41
Knee Effusion	15/50 (30%)	16
pain in calf	1/50 (2%)	1
Sprain muscle leg	1/50 (2%)	1
burning feeling lower limb-foot	1/50 (2%)	1
Stifness	6/50 (12%)	8
fall on knee causing pain	3/50 (6%)	3
inflammation pes anserinus	1/50 (2%)	1
knee twist causing medial bone edema	1/50 (2%)	1
Knee overload	1/50 (2%)	1
Pain meniscus	1/50 (2%)	1
pain on the medial side due medial root tear	1/50 (2%)	1
worsening OA symptoms	1/50 (2%)	1
wrong movement causing knee pain	1/50 (2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
kahler disease	1/50 (2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.