OsteoarthritisNCT02318511
An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis
A study testing Knee injection, ReNu amniotic allograft and Hyaluronic Acid in people with Osteoarthritis, run by NuTech Medical, Inc at 12 sites in United States.
Trial summary
This is a Prospective, Randomized study evaluating the efficacy of ReNu for the treatment of Kellgren-Lawrence grade 2 or 3 osteoarthritis. Patients will be randomized into 1 of 3 groups for injection into the effected knee: 1) ReNu - study treatment, 2) Hyaluronic Acid (HA) injection - with commonly used injection… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Knee injection, ReNu amniotic allograft and Hyaluronic Acid
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 12 sitesUnited States
- Study dates
- Jun 2015to Feb 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with moderate knee osteoarthritis determined by a combination of clinical and radiographic findings and documented by Kellgren-Lawrence radiographic classification (Grade 2 or 3)
- Grade 2 Kellgren-Lawrence radiographic changes are defined as small osteophytes, possible narrowing of joint space
- Grade 3 Kellgren-Lawrence radiographic changes are defined as moderate multiple osteophytes, definite narrowing of joints space, some sclerosis and possible deformity of bone contour.
- Patients with bilateral grade 2 or 3 Kellgren Lawrence knee osteoarthritis who have bilateral symptoms may have their more symptomatic knee injected. If equivalent symptoms are reported by the patient, then the patient will choose which knee is to be injected. The contralateral knee can be treated with local standard of care such as steroid injection, cold therapy or soft brace.
- Age 18 and older
- BMI less than 40
- 7 day average pain score of 4 or greater for the involved knee on a numeric pain scale from 1 to 10.
- Female patients must be actively practicing a contraception method, abstinence, be surgically sterilized, or be postmenopausal
Who cannot join
- Pain medication (including nonsteroidal antiinflammatory drugs, NSAIDs) less than 15 days before injection (may take acetaminophen)
- Receiving pain medication other than acetaminophen for conditions unrelated to osteoarthritis of the index knee
- Regular use of anticoagulants, such as Coumadin, dabigatran or rivaroxaban; use of antiplatelet medications are not a reason for exclusion
- History of substance abuse.
- Failure to agree NOT to take additional knee symptom modifying drugs, other than acetaminophen, during the course of the study without reporting to the study team
- Pregnancy or desire to become pregnant during study duration
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- Positive pregnancy test on premenopausal subject
- Morbid obesity (defined as BMI 40 or greater)
- Symptoms of locking, intermittent block to range of motion or loose body sensation which could indicate meniscal displacement or an intraarticular loose body
- Corticosteroid injection into the index knee within 3 months
- Viscosupplement injection into the index knee within 3 months
- Knee surgery of involved index knee within 12 months
- Knee surgery contralateral knee 6 months
- Worker compensation
- Acute index knee injury (injury within 3 months)
- History of Diabetes mellitus
- History of solid organ or hematologic transplantation
- History of rheumatoid arthritis or other autoimmune disorder
- Diagnosis of a non-basal cell malignancy within the preceding 5 years
- Infection requiring antibiotic treatment within the preceding 3 months
- Current therapy with any immunosuppressive medication, including corticosteroids at a dose > 5 mg per day
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
New Mexico Orthopaedics
Albuquerque, New Mexico, 87106
American Sports Medicine Institute
Birmingham, Alabama, 35205
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
Midwest Orthopedics at Rush, LLC
Chicago, Illinois, 60612
Missouri Orthopaedic Institute (MOI)
Columbia, Missouri, 65212
The Ohio State University
Columbus, Ohio, 43221
Orthoindy
Indianapolis, Indiana, 46143
Center for Clinical and Translational Science UK Chandler Medical Center, Pavilion H
Lexington, Kentucky, 40536-2093
Cedars-Sinai Medical Center
Los Angeles, California, 90048
New York University
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
Advanced Orthopedics
Richmond, Virginia, 23294
About this study
Official title: An Investigation of ReNu™ Knee Injection: Monitoring the Response of Knee Function and Pain in Patients With Osteoarthritis
This is a Prospective, Randomized study evaluating the efficacy of ReNu for the treatment of Kellgren-Lawrence grade 2 or 3 osteoarthritis. Patients will be randomized into 1 of 3 groups for injection into the effected knee: 1) ReNu - study treatment, 2) Hyaluronic Acid (HA) injection - with commonly used injection material and 3) Saline. After treatment, patients will be followed up to 12 months to evaluate improvements using common pain and function subscales.
- Conditions
- Osteoarthritis
- Being tested
- Knee injection, ReNu amniotic allograft, placebo saline, Hyaluronic Acid
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee injectionProcedure or surgery
Injection into knee for the treatment of Osteoarthritis
ReNu amniotic allograftOther
placebo salineDevice
Hyaluronic AcidDevice
| Study group | Role | What they receive |
|---|---|---|
| ReNu amniotic allograft | Experimental | Knee injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. Receives: Procedure: Knee injection; Other: ReNu amniotic allograft |
| Saline | Placebo comparator | Knee injection with saline. Injectable saline will be used as the placebo control. Receives: Procedure: Knee injection; Device: placebo saline |
| HA injection | Active comparator | Knee injection with HA. HA will be used as a viscosupplementation injection consisting of cross linked HA. Receives: Procedure: Knee injection; Device: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Pain Scale Change from Baseline
Measured: 3 months
VAS Pain Scale Change from Baseline
Measured: 6 months
KOOS Pain and Function Subscales Change from Baseline
Measured: 3 months
KOOS Pain and Function Subscales Change from Baseline
Measured: 6 months
Secondary outcomes (3)
KOOS Pain and Function Subscales change from Baseline
Measured: 1 week, 6 weeks, 3 months, and 12 months
Other patient reported outcomes (PROs) change from Baseline
Measured: 1 week, 6 week, 3 months, 6 months, and 12 months
Radiographic (X-ray) measurement of standing joint space change from Baseline
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 posted17 Dec 2014 (estimated)
- Study startJun 2015
- Primary completionJan 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuTech Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Organogenesis
- Responsible party
- Sponsor
- Investigators
- Jack Farr, MD, Principal investigator, OrthoIndy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318511
- Sponsor's protocol ID
- RD2014-10-04
- Status last verified
- Jan 2020
- First submitted
- 9 Dec 2014
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of ReNu™ Knee Injection: Monitoring the Response of Knee Function and Pain in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT02318511
- Acronym / sponsor ID
- RD2014-10-04
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- NuTech Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Organogenesis
- Study start
- Jun 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 17 Dec 2014 (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 is a Prospective, Randomized study evaluating the efficacy of ReNu for the treatment of Kellgren-Lawrence grade 2 or 3 osteoarthritis. Patients will be randomized into 1 of 3 groups for injection into the effected knee: 1) ReNu - study treatment, 2) Hyaluronic Acid (HA) injection - with commonly used injection material and 3) Saline. After treatment, patients will be followed up to 12 months to evaluate improvements using common pain and function subscales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ReNu amniotic allograft | Experimental | Procedure: Knee injection, Other: ReNu amniotic allograftKnee injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. |
| Saline | Placebo comparator | Procedure: Knee injection, Device: placebo salineKnee injection with saline. Injectable saline will be used as the placebo control. |
| HA injection | Active comparator | Procedure: Knee injection, Device: Hyaluronic AcidKnee injection with HA. HA will be used as a viscosupplementation injection consisting of cross linked HA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with moderate knee osteoarthritis determined by a combination of clinical and radiographic findings and documented by Kellgren-Lawrence radiographic classification (Grade 2 or 3)
- Grade 2 Kellgren-Lawrence radiographic changes are defined as small osteophytes, possible narrowing of joint space
- Grade 3 Kellgren-Lawrence radiographic changes are defined as moderate multiple osteophytes, definite narrowing of joints space, some sclerosis and possible deformity of bone contour.
- Patients with bilateral grade 2 or 3 Kellgren Lawrence knee osteoarthritis who have bilateral symptoms may have their more symptomatic knee injected. If equivalent symptoms are reported by the patient, then the patient will choose which knee is to be injected. The contralateral knee can be treated with local standard of care such as steroid injection, cold therapy or soft brace.
- Age 18 and older
Key exclusion criteria (21 listed)
- Pain medication (including nonsteroidal antiinflammatory drugs, NSAIDs) less than 15 days before injection (may take acetaminophen)
- Receiving pain medication other than acetaminophen for conditions unrelated to osteoarthritis of the index knee
- Regular use of anticoagulants, such as Coumadin, dabigatran or rivaroxaban; use of antiplatelet medications are not a reason for exclusion
- History of substance abuse.
- Failure to agree NOT to take additional knee symptom modifying drugs, other than acetaminophen, during the course of the study without reporting to the study team
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 |
|---|---|---|
| Knee injectionInjection into knee for the treatment of Osteoarthritis | Procedure or surgery | HA injection, ReNu amniotic allograft, Saline |
| ReNu amniotic allograft | Other | ReNu amniotic allograft |
| placebo saline | Device | Saline |
| Hyaluronic Acid | Device | HA injection |
Primary outcome
VAS Pain Scale Change from Baseline
Time frame: 3 months
VAS Pain Scale Change from Baseline
Time frame: 6 months
KOOS Pain and Function Subscales Change from Baseline
Time frame: 3 months
KOOS Pain and Function Subscales Change from Baseline
Time frame: 6 months
3 secondary outcomes
KOOS Pain and Function Subscales change from Baseline
Time frame: 1 week, 6 weeks, 3 months, and 12 months
Other patient reported outcomes (PROs) change from Baseline
Time frame: 1 week, 6 week, 3 months, 6 months, and 12 months
Radiographic (X-ray) measurement of standing joint space change from Baseline
Time frame: 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 18 Jan 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.
Jack Farr, MD principal investigator
OrthoIndy
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee injection, ReNu amniotic allograft and Hyaluronic Acid in people with Osteoarthritis, run by NuTech Medical, Inc at 12 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 8 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
VAS Pain Scale Change from Baseline (time frame: 3 months). The study lists 4 primary outcomes in all. 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 18 Jan 2020.