Osteoarthritis of the KneeNCT02768155
Evaluation of Amniotic Fluid Product in Knee Osteoarthritis
A study testing Amniotic Fluid 4.0ml dose and Amniotic Fluid 2.0ml dose in people with Osteoarthritis of the Knee, run by MiMedx Group, Inc. at 2 sites in United States.
Trial summary
A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of subjects with osteoarthritic (OA) knee pain Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Amniotic Fluid 4.0ml dose and Amniotic Fluid 2.0ml dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to Jul 2017
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 30 years or older.
- Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
- Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
Who cannot join
- Subject has active infection at the injection site.
- Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
- BMI greater than 45 kg/m2
- Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
- Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 3 months prior to screening.
- Subject has had major surgery, arthroplasty or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
Show all 15Show fewer
- Subject is pregnant or plans to become pregnant within 180 days of treatment.
- Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
- Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
- Subject has a history of immunosuppressive or chemotherapy in the last 5 years
- Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Subject has had prior radiation at the site
- Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
- Diagnosis of gout in the past 6 month
- Subject has a diagnosis of osteoarthritis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Research Associates, Inc
Birmingham, Alabama, 35205
Weil Foot, Ankle and Orthopedic Institute
Des Plaines, Illinois, 60016
About this study
Official title: Protocol for the Clinical Evaluation Amniotic Fluid (AF) Product in Knee Osteoarthritis
A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of subjects with osteoarthritic (OA) knee pain
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Amniotic Fluid 4.0ml dose, Amniotic Fluid 2.0ml dose, Placebo Control
- Keywords
- OA, Osteoarthritis, Knee
- 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.
Amniotic Fluid 4.0ml doseOther
Injection of Amniotic Fluid
Amniotic Fluid 2.0ml doseOther
Injection of Amniotic Fluid
Placebo ControlOther
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| AF 4.0 | Experimental | Amniotic Fluid 4.0ml dose Receives: Other: Amniotic Fluid 4.0ml dose |
| AF 2.0 | Experimental | Amniotic Fluid 2.0ml dose Receives: Other: Amniotic Fluid 2.0ml dose |
| Placebo | Placebo comparator | Saline Placebo Control Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Pain
Measured: 3 months
Secondary outcomes (4)
Range of Motion
Measured: 3 month
Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: 3 month
WOMAC
Measured: 3 month
Kellgren-Lawrence grade of OA
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Fetterolf, MD, Study director, MiMedx Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768155
- Sponsor's protocol ID
- OFORT001
- Status last verified
- Oct 2017
- First submitted
- 6 May 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Clinical Evaluation Amniotic Fluid (AF) Product in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02768155
- Acronym / sponsor ID
- OFORT001
- Conditions
- Osteoarthritis of the Knee
- Keywords
- OA, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 May 2016 (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.
A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of subjects with osteoarthritic (OA) knee pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AF 4.0 | Experimental | Other: Amniotic Fluid 4.0ml doseAmniotic Fluid 4.0ml dose |
| AF 2.0 | Experimental | Other: Amniotic Fluid 2.0ml doseAmniotic Fluid 2.0ml dose |
| Placebo | Placebo comparator | Other: Placebo ControlSaline Placebo Control |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is 30 years or older.
- Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
- Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
Key exclusion criteria (15 listed)
- Subject has active infection at the injection site.
- Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
- BMI greater than 45 kg/m2
- Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
- Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 3 months prior to screening.
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 |
|---|---|---|
| Amniotic Fluid 4.0ml doseInjection of Amniotic Fluid | Other | AF 4.0 |
| Amniotic Fluid 2.0ml doseInjection of Amniotic Fluid | Other | AF 2.0 |
| Placebo ControlNormal Saline | Other | Placebo |
Primary outcome
Reduction in Pain
Time frame: 3 months
4 secondary outcomes
Range of Motion
Time frame: 3 month
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 3 month
WOMAC
Time frame: 3 month
Kellgren-Lawrence grade of OA
Time frame: 6 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 26 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis of the Knee
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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.
Donald Fetterolf, MD study director
MiMedx Group, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotic Fluid 4.0ml dose and Amniotic Fluid 2.0ml dose in people with Osteoarthritis of the Knee, run by MiMedx Group, Inc. at 2 sites 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 3 inclusion and 15 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Reduction in Pain (time frame: 3 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 26 Oct 2017.