Osteoarthritis, KneePhase 1NCT02262364
Safety of NStride Autologous Protein Solution in the Treatment of Knee Osteoarthritis (PROGRESS I)
A Phase 1 study testing APS in people with Osteoarthritis, Knee, run by Zimmer Biomet at 1 site in United States.
Trial summary
The primary objective of this study is to assess the safety of a single injection of APS. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- APS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Oct 2016
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥40 and ≤75 years old at time of injection..
- A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 (within 6 months of screening).
- Body mass index ≤40 kg/m2.
- A Western Ontario and McMaster Universities osteoarthritis index using the Likert scale, Version 3. (WOMAC LK 3.1) pain subscale total score ≥ 10 and ≤ 19.
- Has undergone at least two prior conservative OA therapies without satisfactory pain relief.
- Patient has failed to get satisfactory pain relief from either HA or steroid injections or would be considered an appropriate patient to receive either HA or steroid injections
Who cannot join
- Presence of active infection or abnormal effusion in the knee immediately preceding treatment injection.
- Presence of symptomatic OA in the non-study knee
- Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases, or of metabolic origin; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, villonodular synovitis, and other non-OA joint disease.
- Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the index knee
- Untreated symptomatic injury of index knee (e.g., acute traumatic injury, anterior cruciate ligament injury, meniscus injury, cartilage lesion).
- Knee radiographs showing bone-on-bone or other gross cartilage deficits.
Show all 21Show fewer
- Presence of surgical hardware or other foreign body in the index knee.
- Intra-articular steroid injections in the index knee within 3 months of screening.
- Intra-articular HA in the index knee within 6 months of screening.
- Other intra-articular therapy in the index knee within 6 months prior to screening.
- Systemic steroid use within 2 weeks of screening.
- Planned/anticipated surgery of the index knee during the study period.
- A history of local anesthetic allergy
- Use of systemic immunosuppressants within six weeks of treatment.
- Currently on anticoagulant therapy
- Any documented clinically significant condition (e.g., diabetes, malignancy), finding, or psychiatric illness at screening which could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection.
- Skin breakdown at the index knee where the injection is planned to take place.
- Pregnant or nursing mothers or women who are planning on getting pregnant during the time they will be participating in the study.
- Known drug or alcohol dependence currently or within the last year.
- Used any investigational drug or device within 30 days prior to screening.
- Used any investigational biologic within 60 days prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic and Sports Medicine Center of Northern Indiana (OSMC)
Elkhart, Indiana, 46550
About this study
Official title: A Pilot Study of a Single Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis
The primary objective of this study is to assess the safety of a single injection of APS.
Read the detailed description
The primary objective of this study is to assess the safety of a single injection of APS in patients with painful unilateral knee osteoarthritis and who have not been able to get satisfactory pain relief with other treatments through one-month post treatment and monitor subjects for adverse events through 12 months.
- Conditions
- Osteoarthritis, Knee
- Being tested
- APS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APSBiological
See above
| Study group | Role | What they receive |
|---|---|---|
| NStride APS | Experimental | Subjects will receive an intra-articular injection of APS. Receives: Biological: APS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Adverse Events and Serious Adverse Events
Measured: 1 Year
Secondary outcomes (3)
Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire
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).
Measured: 12 months
Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)
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.
Measured: 12 months
Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionOct 2016
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 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet Biologics, LLC
- Responsible party
- Sponsor
- Investigators
- Mark Klaassen, Principal investigator, OSMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262364
- Sponsor's protocol ID
- APSS-22-01
- Status last verified
- Oct 2018
- First submitted
- 19 Sep 2014
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Single Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02262364
- Acronym / sponsor ID
- APSS-22-01
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet Biologics, LLC
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the safety of a single injection of APS.
Detailed description
The primary objective of this study is to assess the safety of a single injection of APS in patients with painful unilateral knee osteoarthritis and who have not been able to get satisfactory pain relief with other treatments through one-month post treatment and monitor subjects for adverse events through 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NStride APS | Experimental | Biological: APSSubjects will receive an intra-articular injection of APS. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥40 and ≤75 years old at time of injection..
- A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 (within 6 months of screening).
- Body mass index ≤40 kg/m2.
- A Western Ontario and McMaster Universities osteoarthritis index using the Likert scale, Version 3. (WOMAC LK 3.1) pain subscale total score ≥ 10 and ≤ 19.
- Has undergone at least two prior conservative OA therapies without satisfactory pain relief.
Key exclusion criteria (21 listed)
- Presence of active infection or abnormal effusion in the knee immediately preceding treatment injection.
- Presence of symptomatic OA in the non-study knee
- Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases, or of metabolic origin; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, villonodular synovitis, and other non-OA joint disease.
- Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the index knee
- Untreated symptomatic injury of index knee (e.g., acute traumatic injury, anterior cruciate ligament injury, meniscus injury, cartilage lesion).
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 |
|---|---|---|
| APSSee above | Biological | NStride APS |
Primary outcome
Adverse Events
Time frame: 1 Year
Adverse Events and Serious Adverse Events
3 secondary outcomes
Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire
Time frame: 12 months
Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)
Time frame: 12 months
Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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.
Mark Klaassen principal investigator
OSMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APS in people with Osteoarthritis, Knee, run by Zimmer Biomet at 1 site in United States.
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 6 inclusion and 21 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 15 Feb 2019. 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 States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 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?
Adverse Events (time frame: 1 Year). 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 15 Feb 2019.