Osteochondral DefectNCT03036878
ReNu™ Marrow Stimulation Augmentation
A study testing ReNu in people with Osteochondral Defect, run by NuTech Medical, Inc at 2 sites in United States.
Trial summary
To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for osteochondral lesions Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Osteochondral Defect
- What is being tested?
- ReNu
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Feb 2017to 6 Dec 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Voluntary signature of the IRB approved Informed Consent
- Male or female participants between the ages of 18-55
- If female:
- Actively practicing a contraception method, or
- Practicing abstinence, or
- Surgically sterilized, or
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- Postmenopausal
- Pretreatment arthroscopic confirmation indicating one or two contained lesion(s) and equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle, patella, or trochlear groove and OCD lesions (Grade 4a) with healed bone base, which is non-sclerotic and no loss of bone greater then 6mm measured from the surrounding subchondral plate. Original pretreatment arthroscopic confirmation indicates that one or two lesion(s) are equal to an ICRS Grade 3a, 3b, 3c, 3d contained lesion(s) that is equivalent to an Outerbridge Grade III or IV (greater than 50% loss of articular cartilage). OF NOTE: Patients with need for concomitant procedures such as Anteromedialization of Tibial Tubercle (AMZ) and lateral lengthening are allowable
- Has peripheral cartilage debridement to healthy cartilage that results in a lesion (s) with an area of > or = 1cm ^2 and < or = 4 cm^2.
- PCL, LCL and MCL in the affected knee are stable and the ACL is stable or can be stabilized as a concomitant procedure.
- Ipsilateral knee compartment has intact menisci (or requires partial meniscectomy resulting in stable menisci). Minimum remnant width of 5mm.
- The contralateral knee is asymptomatic, stable, and fully functional.
- Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical and radiographic visits through 24 months.
- Alignment: Mechanical axis must be no more than 5 degrees from neutral.
- Must be 3 months post previous surgery.
Who cannot join
- Clinical and/or radiographic disease diagnosis of the indexed affected joint that Includes:
- Osteoarthritis or avascular necrosis,
- Rheumatoid arthritis, or history of septic or reactive arthritis,
- Gout or history of gout or pseudogout in the affected knee,
- Osteochondritis dissecans of the knee with significant bone loss (greater than 6mm deep from the subchondral plate)
- Associated damage to the underlying subchondral bone requiring a bone graft
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- History of secondary arthropathies (i.e. sickle cell disease, hemochromatosis, or autoimmune disease).
- Uncontrolled diabetes.
- Displays a high surgical risk due to unstable cardiac and/or pulmonary disease.
- Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint.
- Is at substantial risk for the need of organ transplantation, such as renal insufficiency.
- Is pregnant or breast-feeding.
- Body mass index > 35.
- Has bipolar articular cartilage involvement or kissing lesions of the ipsilateral compartment, described as tibial or patellar lesions in the same compartment with greater than ICRS Grade 2 chondrosis.
- Is participating concurrently in another clinical trial, or has participated in a clinical trial within 30 days of surgery.
- Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulants, or taking corticosteroids.
- Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee.
- Active joint infection.
- Prior total meniscectomy of either knee.
- Radiographically has >5 degrees of malalignment as measured from the hip, knee and ankle mechanical axis.
- Has subchondral bone loss of greater than 6mm
- Has received within the past three months intra-articular platelet rich plasma, hyaluronic acid therapy, steroid, amniotic-derived or stem cell injections in the index knee.
- Prior realignment surgery in the affected knee within the past 6 months.
- Failed microfracture/marrow stimulation treatment performed less than 12-months before baseline.
- Is receiving workman's compensation or currently involved in litigation relating to the index knee.
- Has history of alcoholism, medication, or intravenous drug abuse, psychosis, is a prisoner, has a personality disorder (s), poor motivation, emotional or intellectual issues that would likely make the subject unreliable for the study, or any combination of variables in the investigator's judgment that should exclude a potential subject.
- Any conditions or implants that might affect having MRIs: had or have an aneurysm clip implanted, intraocular foreign bodies (commonly seen in welders), subcutaneous metal shards (found in sheet metal workers), or some shrapnel; additionally, no cardiac pacemaker, defibrillator, implanted neurostimulater (TENS implants) some prosthetic heart valve (especially mitral valve), cochlear implant or other hearing aide. Subjects should be excluded if they have a tendency of claustrophobia or have tattoos that may contain iron-based dyes.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Orthoindy
Indianapolis, Indiana, 46143
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Evaluation of the ReNu™ Amniotic Suspension Allograft After Marrow Stimulation in the Treatment of Osteochondral Defects
To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for osteochondral lesions
Read the detailed description
This is a prospective, non-randomized, longitudinal study of up to 8 evaluable participants recruited from two separate practices. Male and non-pregnant female patients between the ages of 18 and 55 years of age will be screened for study recruitment. Female patients must be actively practicing a contraception method, abstinence, be surgically sterilized, or be postmenopausal. Participants will receive ReNu™ as an adjunct to their standard of care marrow stimulation for the treatment of osteochondral defects.
At each follow-up visit, concomitant medications and adverse events shall be collected from each subject, and each subject shall complete the following questionnaires:
IKDC Health Assessment (Includes Short Form-36) Tegner KOOS Knee Survey VAS Pain Scale SANE score
The subjects will be assessed at Baseline using these scales an again at all subsequent study follow-up visits.
- Conditions
- Osteochondral Defect
- Being tested
- ReNu
- Keywords
- Osteochondral, Marrow Stimulation, ReNu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReNuOther
ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
| Study group | Role | What they receive |
|---|---|---|
| ReNu Injection | Experimental | Injection of ReNu allograft into the joint capsule. Receives: Other: ReNu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KOOS score from baseline
Measured: 1 Year
Change in Tegner score from baseline
Measured: 1 Year
Secondary outcomes (4)
Change in VAS score from baseline
Measured: 6, 12 & 24 months
Change in Tegner score from baseline
Measured: 6 & 24 months
Change in SANE score from baseline
Measured: 6, 12 & 24 months
Change in KOOS score from baseline
Measured: 6 & 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start7 Feb 2017
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Why it stopped: Closed for lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral DefectStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT03036878
- Sponsor's protocol ID
- RD-2016-04-02
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the ReNu™ Amniotic Suspension Allograft After Marrow Stimulation in the Treatment of Osteochondral Defects
- ClinicalTrials.gov ID
- NCT03036878
- Acronym / sponsor ID
- RD-2016-04-02
- Conditions
- Osteochondral Defect
- Keywords
- Osteochondral, Marrow Stimulation, ReNu
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed for lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- NuTech Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Organogenesis
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 30 Jan 2017 (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.
To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for osteochondral lesions
Detailed description
This is a prospective, non-randomized, longitudinal study of up to 8 evaluable participants recruited from two separate practices. Male and non-pregnant female patients between the ages of 18 and 55 years of age will be screened for study recruitment. Female patients must be actively practicing a contraception method, abstinence, be surgically sterilized, or be postmenopausal. Participants will receive ReNu™ as an adjunct to their standard of care marrow stimulation for the treatment of osteochondral defects.
At each follow-up visit, concomitant medications and adverse events shall be collected from each subject, and each subject shall complete the following questionnaires:
IKDC Health Assessment (Includes Short Form-36) Tegner KOOS Knee Survey VAS Pain Scale SANE score
The subjects will be assessed at Baseline using these scales an again at all subsequent study follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReNu Injection | Experimental | Other: ReNuInjection of ReNu allograft into the joint capsule. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Voluntary signature of the IRB approved Informed Consent
- Male or female participants between the ages of 18-55
- If female:
- Pretreatment arthroscopic confirmation indicating one or two contained lesion(s) and equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle, patella, or trochlear groove and OCD lesions (Grade 4a) with healed bone base, which is non-sclerotic and no loss of bone greater then 6mm measured from the surrounding subchondral plate. Original pretreatment arthroscopic confirmation indicates that one or two lesion(s) are equal to an ICRS Grade 3a, 3b, 3c, 3d contained lesion(s) that is equivalent to an Outerbridge Grade III or IV (greater than 50% loss of articular cartilage). OF NOTE: Patients with need for concomitant procedures such as Anteromedialization of Tibial Tubercle (AMZ) and lateral lengthening are allowable
- Has peripheral cartilage debridement to healthy cartilage that results in a lesion (s) with an area of > or = 1cm ^2 and < or = 4 cm^2.
Key exclusion criteria (27 listed)
- Clinical and/or radiographic disease diagnosis of the indexed affected joint that Includes:
- History of secondary arthropathies (i.e. sickle cell disease, hemochromatosis, or autoimmune disease).
- Uncontrolled diabetes.
- Displays a high surgical risk due to unstable cardiac and/or pulmonary disease.
- Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint.
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 |
|---|---|---|
| ReNuReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid. | Other | ReNu Injection |
Primary outcome
Change in KOOS score from baseline
Time frame: 1 Year
Change in Tegner score from baseline
Time frame: 1 Year
4 secondary outcomes
Change in VAS score from baseline
Time frame: 6, 12 & 24 months
Change in Tegner score from baseline
Time frame: 6 & 24 months
Change in SANE score from baseline
Time frame: 6, 12 & 24 months
Change in KOOS score from baseline
Time frame: 6 & 24 months
Results and safety
The study was stopped early (reason given: Closed for lack of enrollment). Results are not available in the source record.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReNu in people with Osteochondral Defect, run by NuTech Medical, 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 15 inclusion and 27 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: stopped early, 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 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. 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 was stopped early (reason given: Closed for lack of enrollment). Results are not available in the source record.
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?
Change in KOOS score from baseline (time frame: 1 Year). The study lists 2 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.