Patellofemoral OsteoarthritisNCT02610192

nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis

A study testing nSTRIDE Autologous Protein Solution (APS) Kit in people with Patellofemoral Osteoarthritis, run by Zimmer Biomet at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 65 years, women only
Conditions the study is for: Patellofemoral Osteoarthritis
What is being tested?: nSTRIDE Autologous Protein Solution (APS) Kit
Type of treatment: Injection or infusion, Medical device
How many people: 52 participants
Where: 1 siteBelgium
Study dates: Mar 2016to Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

AZ Monica
Deurne

Other trials in Belgium

About this study

Official title: A Prospective Study of a Single Intra-Articular Injection of Autologous Protein Solution in Females With Primary Patellofemoral Osteoarthritis

Read the 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).

Conditions: Patellofemoral Osteoarthritis
Being tested: nSTRIDE Autologous Protein Solution (APS) Kit
Keywords: Autologous Protein Solution, Patellofemoral Osteoarthritis, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nSTRIDE Autologous Protein Solution (APS) KitDevice
Intra-articular injection of APS

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 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
Measured: Baseline, 1, 3, 6 and 12 Months
Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 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
Measured: Baseline, 1, 3, 6 and 12 Months
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
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
Measured: Baseline, 1, 3, 6 and 12 Months
Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 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
Measured: Baseline, 1, 3, 6 and 12 Months
Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 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
Measured: Baseline, 1, 3, 6 and 12 Months
Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 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
Measured: Baseline, 1, 3, 6 and 12 Months
Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 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
Measured: Baseline, 1, 3, 6 and 12 Months
Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 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
Measured: Baseline, 1, 3, 6 and 12 Months
Activity Measured With UCLA Activity Score Questionnaire at 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
Measured: Baseline, 1, 3, 6 and 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Jun 2018

First posted20 Nov 2015 (estimated)
Study startMar 2016
Primary completionJun 2018
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Patellofemoral OsteoarthritisStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02610192
Sponsor's protocol ID: BBIO.CR.APSPFO.001.15
Other IDs: APSS-55-00
Status last verified: Jun 2020
First submitted: 10 Nov 2015
Last updated: 12 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
RecruitingObservational study
Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms
Knee Osteoarthritis, Patellofemoral Pain (PFPS)
Active, not recruiting
Persona Ti-Nidium Post-Market Clinical Follow-up
Knee Pain Chronic, Osteoarthritis
RecruitingPhase 2
Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.
Patellofemoral Osteoarthritis
RecruitingObservational study
FDG PET/MRI Imaging of Patellofemoral Joint Osteoarthritis
Patellofemoral Osteoarthritis, Knee Osteoarthritis

All Patellofemoral Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study of a Single Intra-Articular Injection of Autologous Protein Solution in Females With Primary Patellofemoral Osteoarthritis
ClinicalTrials.gov ID: NCT02610192
Acronym / sponsor ID: BBIO.CR.APSPFO.001.15
Conditions: Patellofemoral Osteoarthritis
Keywords: Autologous Protein Solution, Patellofemoral Osteoarthritis, Female
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Mar 2016 (actual)
Primary completion: Jun 2018 (actual)
Study completion: Jun 2018 (actual)
First posted: 20 Nov 2015 (estimated)
Results: Posted 2 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 40 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nSTRIDE Autologous Protein Solution (APS) KitIntra-articular injection of APS	Device	–

Primary outcome

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

9 secondary outcomes

Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months
Time frame: Baseline, 1, 3, 6 and 12 Months
Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months
Time frame: Baseline, 1, 3, 6 and 12 Months
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
Time frame: Baseline, 1, 3, 6 and 12 Months
Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months
Time frame: Baseline, 1, 3, 6 and 12 Months
Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months
Time frame: Baseline, 1, 3, 6 and 12 Months
Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months
Time frame: Baseline, 1, 3, 6 and 12 Months
Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months
Time frame: Baseline, 1, 3, 6 and 12 Months
Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months
Time frame: Baseline, 1, 3, 6 and 12 Months
Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months
Time frame: Baseline, 1, 3, 6 and 12 Months

Results and safety

Results posted to the registry on 2 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
nSTRIDE APS	50	41

Primary outcome: Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months

Time frame: Baseline, 1, 3, 6 and 12 Months. Mean (Standard Deviation). Unit: score on a scale

Measure	nSTRIDE APS n = 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)

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

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: month 1, month 3, month 6 and month 12. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
nSTRIDE APS	3 of 50 (6%)	39 of 50 (78%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Patellofemoral Osteoarthritis

Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
RecruitingObservational study
Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms
Knee Osteoarthritis, Patellofemoral Pain (PFPS)
Active, not recruiting
Persona Ti-Nidium Post-Market Clinical Follow-up
Knee Pain Chronic, Osteoarthritis
RecruitingPhase 2
Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.
Patellofemoral Osteoarthritis
RecruitingObservational study
FDG PET/MRI Imaging of Patellofemoral Joint Osteoarthritis
Patellofemoral Osteoarthritis, Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Verdonk, MD principal investigator

AZ Monica, Deurne

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing nSTRIDE Autologous Protein Solution (APS) Kit in people with Patellofemoral Osteoarthritis, run by Zimmer Biomet at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months (time frame: Baseline, 1, 3, 6 and 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02610192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.