Osteoarthritis, KneePROGRESS IIINCT02580643
Prospective Post-Market Data Collection on Patients With Knee OA and Treated With nSTRIDE APS
An observational study of Osteoarthritis, Knee, run by Zimmer Biomet at 1 site in United Kingdom.
Trial summary
This study will document treatment effects, changes in quality of life, procedure complications, adverse events, healthcare resource utilization, and further needed intervention(s) following treatment with nSTRIDE autologous protein solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- APS
- Type of treatment
- Injection or infusion
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to 30 Jun 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with bilateral or unilateral knee OA will be prospectively enrolled in the study.
Who may be able to join
- OA of one or both knees as diagnosed by the treating physician
- At least 18 years of age
- Willing and able to comply with the study procedures
- Signed informed consent form
Who cannot join
- Any systemic inflammatory condition ( e.g., rheumatoid arthritis)
- Active malignancy at time of injection
- Pregnant at time of injection
- Lactating at the 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
- Participating in another device or drug study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Post-Market Data Collection on Patients With Knee Osteoarthritis and Treated With nSTRIDE Autologous Protein Solution (REGP-22-00)
This study will document treatment effects, changes in quality of life, procedure complications, adverse events, healthcare resource utilization, and further needed intervention(s) following treatment with nSTRIDE autologous protein solution. This study will also allow for the documentation of the same parameters following multiple injections of autologous protein solution to treat knee 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. It appears that the safety of autologous therapies is roughly equivalent across different processing methods. However, making generalizations regarding the effectiveness across these autologous therapies is more complicated. Thus, 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 small pilot trial. However, demonstration of the treatment effects in a more heterogeneous population is lacking. Further, neither the effect time course nor the utility of multiple injections has been documented. This study will allow for low burden, efficient data collection in a larger heterogeneous population of persons suffering from knee OA. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following single or repeated injections.
- Conditions
- Osteoarthritis, Knee
- Being tested
- APS
- Keywords
- Autologous Protein Solution, Osteoarthritis, Intra-articular Injection
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APSBiological
intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| APS Injection | Autologous Protein Solution Receives: Biological: APS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain and function
Quantify and characterize the percentage of OMERACT-OARSI high improvement in pain responders at all post-injection time points. OMERACT-OARSI high improvement in pain responders are defined as subjects who show a 50% improvement in the KOOS pain sub-scale score and an absolute improvement of at least 20 points on the KOOS pain subscale score.
Measured: Through 12 months
Secondary outcomes (5)
Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment.
Measured: Through 12 months
Numeric Rating Scales (NRS)
Quantify the change in knee pain, stiffness and function
Measured: Evaluated at 2 and 4 weeks and 3, 6 and 12 months
European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L)
Quantify the change in quality of life
Measured: Evaluated at 2 and 4 weeks and 3, 6 and 12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Quantify changes in pain, symptoms, activities of daily life, engagement in sports and recreation and quality of living
Measured: Evaluated at 2 and 4 weeks and 3, 6 and 12 months
Procedural complications and adverse events
Measured: Through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startMay 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580643
- Sponsor's protocol ID
- BBIO.CRNSAPS002.15
- Acronym
- PROGRESS III
- Status last verified
- Jun 2020
- First submitted
- 19 Oct 2015
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post-Market Data Collection on Patients With Knee Osteoarthritis and Treated With nSTRIDE Autologous Protein Solution (REGP-22-00)
- ClinicalTrials.gov ID
- NCT02580643
- Acronym / sponsor ID
- PROGRESS III / BBIO.CRNSAPS002.15
- Conditions
- Osteoarthritis, Knee
- Keywords
- Autologous Protein Solution, Osteoarthritis, Intra-articular Injection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will document treatment effects, changes in quality of life, procedure complications, adverse events, healthcare resource utilization, and further needed intervention(s) following treatment with nSTRIDE autologous protein solution. This study will also allow for the documentation of the same parameters following multiple injections of autologous protein solution to treat knee osteoarthritis.
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. It appears that the safety of autologous therapies is roughly equivalent across different processing methods. However, making generalizations regarding the effectiveness across these autologous therapies is more complicated. Thus, 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 small pilot trial. However, demonstration of the treatment effects in a more heterogeneous population is lacking. Further, neither the effect time course nor the utility of multiple injections has been documented. This study will allow for low burden, efficient data collection in a larger heterogeneous population of persons suffering from knee OA. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following single or repeated injections.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APS Injection | – | Biological: APSAutologous Protein Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with bilateral or unilateral knee OA will be prospectively enrolled in the study.
Key inclusion criteria (4 listed)
- OA of one or both knees as diagnosed by the treating physician
- At least 18 years of age
- Willing and able to comply with the study procedures
- Signed informed consent form
Key exclusion criteria (7 listed)
- Any systemic inflammatory condition ( e.g., rheumatoid arthritis)
- Active malignancy at time of injection
- Pregnant at time of injection
- Lactating at the 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 |
|---|---|---|
| APSintra-articular injection | Biological | APS Injection |
Primary outcome
Knee pain and function
Time frame: Through 12 months
Quantify and characterize the percentage of OMERACT-OARSI high improvement in pain responders at all post-injection time points. OMERACT-OARSI high improvement in pain responders are defined as subjects who show a 50% improvement in the KOOS pain sub-scale score and an absolute improvement of at least 20 points on the KOOS pain subscale score.
5 secondary outcomes
Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment.
Time frame: Through 12 months
Numeric Rating Scales (NRS)
Time frame: Evaluated at 2 and 4 weeks and 3, 6 and 12 months
European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L)
Time frame: Evaluated at 2 and 4 weeks and 3, 6 and 12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Evaluated at 2 and 4 weeks and 3, 6 and 12 months
Procedural complications and adverse events
Time frame: Through 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Zimmer Biomet at 1 site in United Kingdom.
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 4 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 11 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee pain and function (time frame: Through 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2020.