Osteoarthritis, KneePhase 4NCT04201743
An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
A Phase 4 study testing Acellular amniotic membrane derived allograft injection (NuDYN) in people with Osteoarthritis, Knee, run by Illinois Center for Orthopaedic Research and Education at 1 site in United States.
Trial summary
The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft injection for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Acellular amniotic membrane derived allograft injection (NuDYN)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2020to Dec 2021
- Phase
- Phase 4
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 21 to 80 years
- Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale
Who cannot join
- Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
- BMI greater than 40 kg/m2
- Subject has active infection at the injection site
- Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy.
- Subject has rheumatoid arthritis, psoriatic arthritis or has been diagnosed with any other disorder that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor or cancer
- Subject has documented history of gout or pseudo-gout
Show all 21Show fewer
- Subject has an autoimmune disease or known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
- Subject has received any of the following to the target knee:
- Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
- Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment
- Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
- Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
- History of partial or total knee arthroplasty
- Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
- Subject has a history of immunosuppressive or chemotherapy in the last 5 years
- Subject has had prior radiation at the site
- Subject is currently taking narcotic medication for any reason.
- Subject is pregnant or plans to become pregnant within 365 days of treatment
- Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- Subject is a worker's compensation patient
- Subject is a prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Hinsdale Orthopaedic Associates
Westmont, Illinois, 60559
About this study
Official title: A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft injection for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection.
Read the detailed description
It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL).
60 subjects will be enrolled in this study. Subjects will be randomized 1:1 in treatment arms.
Each of the patient will be treated with one time injection to the knee. Methods for collecting data will be through validated patient-reported outcome tools (KOOS, VAS and WOMAC questionnaire) that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Acellular amniotic membrane derived allograft injection (NuDYN)
- Keywords
- Osteoarthritis, Knee, Amniotic membrane, Allograft
- 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.
Acellular amniotic membrane derived allograft injection (NuDYN)Drug
Injectable acellular amniotic membrane derived allograft (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) in the treatment of knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| 1 mL NyDYN injection | Active comparator | 30 patients (out of 60) will be doubled blinded randomized to this arm and get 1 mL NyDYN injection. Receives: Drug: Acellular amniotic membrane derived allograft injection (NuDYN) |
| 2 mL NyDYN injection | Active comparator | 30 patients (out of 60) will be doubled blinded randomized to this arm and get 2 mL NyDYN injection. Receives: Drug: Acellular amniotic membrane derived allograft injection (NuDYN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: 180 days
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).
Measured: 180 days
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
Measured: 180 days
Secondary outcomes (3)
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: 90, 180 and 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).
Measured: 90, 180 and 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Change from baseline Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
Measured: 90, 180 and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start30 Mar 2020
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Resources limited secondary to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Data will be prospectively collected on all injectable acellular amniotic membrane derived allograft knee performed at our institute. Inclusion criteria will be all patients age between 21 and 80 years with a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. Methods for collecting data will be through validated patient-reported outcome tools that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illinois Center for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronak M. Patel, Illinois Center for Orthopaedic Research and Education
- Investigators
- Ronak Patel, MD, Principal investigator, Illinois Center for Orthopedic Research and Education (iCORE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201743
- Sponsor's protocol ID
- 199608
- Status last verified
- Sep 2020
- First submitted
- 8 Dec 2019
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34. doi: 10.1177/0363546515612750. Epub 2015 Nov 19.
PubMed 26585668Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. 2016 Aug;29(6):443-50. doi: 10.1055/s-0035-1569481. Epub 2015 Dec 18.
PubMed 26683979
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT04201743
- Acronym / sponsor ID
- 199608
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Amniotic membrane, Allograft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Resources limited secondary to COVID-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Illinois Center for Orthopaedic Research and EducationUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Dec 2019 (actual)
- 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.
The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft injection for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection.
Detailed description
It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL).
60 subjects will be enrolled in this study. Subjects will be randomized 1:1 in treatment arms.
Each of the patient will be treated with one time injection to the knee. Methods for collecting data will be through validated patient-reported outcome tools (KOOS, VAS and WOMAC questionnaire) that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Data will be prospectively collected on all injectable acellular amniotic membrane derived allograft knee performed at our institute. Inclusion criteria will be all patients age between 21 and 80 years with a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. Methods for collecting data will be through validated patient-reported outcome tools that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.
| Arm | Type | Receives |
|---|---|---|
| 1 mL NyDYN injection | Active comparator | Drug: Acellular amniotic membrane derived allograft injection (NuDYN)30 patients (out of 60) will be doubled blinded randomized to this arm and get 1 mL NyDYN injection. |
| 2 mL NyDYN injection | Active comparator | Drug: Acellular amniotic membrane derived allograft injection (NuDYN)30 patients (out of 60) will be doubled blinded randomized to this arm and get 2 mL NyDYN injection. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 21 to 80 years
- Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale
Key exclusion criteria (21 listed)
- Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
- BMI greater than 40 kg/m2
- Subject has active infection at the injection site
- Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy.
- Subject has rheumatoid arthritis, psoriatic arthritis or has been diagnosed with any other disorder that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor or cancer
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 |
|---|---|---|
| Acellular amniotic membrane derived allograft injection (NuDYN)Injectable acellular amniotic membrane derived allograft (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) in the treatment of knee osteoarthritis. | Drug | 1 mL NyDYN injection, 2 mL NyDYN injection |
Primary outcome
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Time frame: 180 days
Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Time frame: 180 days
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Time frame: 180 days
Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
3 secondary outcomes
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Time frame: 90, 180 and 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Time frame: 90, 180 and 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Time frame: 90, 180 and 365 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Background: PubMed 26585668Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34. doi: 10.1177/0363546515612750. Epub 2015 Nov 19.
- Background: PubMed 26683979Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. 2016 Aug;29(6):443-50. doi: 10.1055/s-0035-1569481. Epub 2015 Dec 18.
- Individual participant dataSharing planned: No
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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.
Ronak Patel, MD principal investigator
Illinois Center for Orthopedic Research and Education (iCORE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acellular amniotic membrane derived allograft injection (NuDYN) in people with Osteoarthritis, Knee, run by Illinois Center for Orthopaedic Research and Education 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 2 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: withdrawn, as of the sponsor's last update on 5 Oct 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires (time frame: 180 days). The study lists 3 primary outcomes in all. 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 NCT04201743, which also lists 2 linked publications.
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 5 Oct 2020; AzTrials last refreshed its copy on 5 Nov 2026.