Osteoarthritis, KneeNCT03074526
Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis
A study testing Amniotic Fluid in people with Osteoarthritis, Knee, run by MiMedx Group, Inc. at 4 sites in United States.
Trial summary
To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Amniotic Fluid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Jan 2017to 25 Apr 2018
- 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.
- Subject must have a VAS pain scale greater than 30.
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 12 weeks prior to screening.
- Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
- Subject has had major surgery 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 17Show 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 Syndromes (AIDS) or HIV
- Subject has had prior radiation at the site
- Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
- New diagnosis of gout in the past 6 month
- Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale.
- Subject has a diagnosis of Osteonecrosis of the knee.
- Subject has had a total knee replacement.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Southeastern Center for Clinical Trials
Atlanta, Georgia, 30033
Central Research Associates, Inc
Birmingham, Alabama, 35205
Weil Foot, Ankle and Orthopedic Institute
Des Plaines, Illinois, 60016
Hinsdale Orthopaedic Associates
Hinsdale, Illinois, 60521
About this study
Official title: Prospective, Double Blinded Randomized Multi-Center Controlled Trial Evaluating the 2 Different Doses of Lyophilized Amniotic Fluid Compared to a Saline Placebo Injection in the Treatment of Subjects With Osteoarthritic (OA) Knee Pain
To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee.
Read the detailed description
Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x). The estimated enrollment period is 6 months. Each subject will receive 1 injection and be evaluated for efficacy and safety during a 6 month observation period. The study is expected to be completed within 12 months, inclusive of enrollment and follow-up for all subjects.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Amniotic Fluid, Saline Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic FluidOther
Amniotic Fluid
Saline PlaceboOther
Saline Placebo
| Study group | Role | What they receive |
|---|---|---|
| 4mL amniotic fluid | Active comparator | Amniotic Fluid: 4mL dose of amniotic fluid Receives: Other: Amniotic Fluid |
| 4mL2x amniotic fluid | Active comparator | Amniotic Fluid: 4mL 2x dose of amniotic fluid Receives: Other: Amniotic Fluid |
| 4mL Saline Placebo | Placebo comparator | Normal Saline Receives: Other: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Pain
The proportion of subjects who experience at least 20% improvement over baseline in Visual Analog Scale for Pain at 3 months in the Lyophilized amniotic fluid Injectable versus placebo-treated group.
Measured: 3 month
Secondary outcomes (4)
Range of Motion
subjects who experience a level of improvement in function as assessed by range of motion at 3 months
Measured: 3 months
Knee Injury and Osteoarthritis Outcome Score
measurement to assess the patient's opinion about their knee and associated problems by looking at pain, functions of daily living, function in sports and recreation, knee related quality of life and other symptoms
Measured: 4weeks, 6weeks, 3 months, 16 weeks, 6 months
SF-12 Health Health Survey
patient-reported survey assessing patient health
Measured: 4weeks, 6weeks, 3 months, 16 weeks, 6 months
Activity of Daily Living Questionnaire
Changes in the subject's physical activity level
Measured: 4weeks, 6weeks, 3 months, 16 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start23 Jan 2017
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
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.
- 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
- Model description
- Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Mason, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074526
- Sponsor's protocol ID
- OFORT003
- Status last verified
- Nov 2020
- First submitted
- 27 Jan 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double Blinded Randomized Multi-Center Controlled Trial Evaluating the 2 Different Doses of Lyophilized Amniotic Fluid Compared to a Saline Placebo Injection in the Treatment of Subjects With Osteoarthritic (OA) Knee Pain
- ClinicalTrials.gov ID
- NCT03074526
- Acronym / sponsor ID
- OFORT003
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 8 Mar 2017 (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.
To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee.
Detailed description
Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x). The estimated enrollment period is 6 months. Each subject will receive 1 injection and be evaluated for efficacy and safety during a 6 month observation period. The study is expected to be completed within 12 months, inclusive of enrollment and follow-up for all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x).
| Arm | Type | Receives |
|---|---|---|
| 4mL amniotic fluid | Active comparator | Other: Amniotic FluidAmniotic Fluid: 4mL dose of amniotic fluid |
| 4mL2x amniotic fluid | Active comparator | Other: Amniotic FluidAmniotic Fluid: 4mL 2x dose of amniotic fluid |
| 4mL Saline Placebo | Placebo comparator | Other: Saline PlaceboNormal Saline |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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.
- Subject must have a VAS pain scale greater than 30.
Key exclusion criteria (17 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 12 weeks prior to screening.
- Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 12 weeks 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 FluidAmniotic Fluid | Other | 4mL amniotic fluid, 4mL2x amniotic fluid |
| Saline PlaceboSaline Placebo | Other | 4mL Saline Placebo |
Primary outcome
Reduction in Pain
Time frame: 3 month
The proportion of subjects who experience at least 20% improvement over baseline in Visual Analog Scale for Pain at 3 months in the Lyophilized amniotic fluid Injectable versus placebo-treated group.
4 secondary outcomes
Range of Motion
Time frame: 3 months
Knee Injury and Osteoarthritis Outcome Score
Time frame: 4weeks, 6weeks, 3 months, 16 weeks, 6 months
SF-12 Health Health Survey
Time frame: 4weeks, 6weeks, 3 months, 16 weeks, 6 months
Activity of Daily Living Questionnaire
Time frame: 4weeks, 6weeks, 3 months, 16 weeks, 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 13 Nov 2020.
- 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.
David Mason, MD study director
Chief Medical Officer
4 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 in people with Osteoarthritis, Knee, run by MiMedx Group, Inc. at 4 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 4 inclusion and 17 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 month). 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 13 Nov 2020.