ReNu™ Marrow Stimulation Augmentation
Evaluation of the ReNu™ Amniotic Suspension Allograft After Marrow Stimulation in the Treatment of Osteochondral Defects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46143
- OrthoIndy
-
-
New York
-
New York, New York, United States, 10021
- Hospital For Special Surgery
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: ReNu Injection
Injection of ReNu allograft into the joint capsule.
|
ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in KOOS score from baseline
Time Frame: 1 Year
|
1 Year
|
|
Change in Tegner score from baseline
Time Frame: 1 Year
|
1 Year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in VAS score from baseline
Time Frame: 6, 12 & 24 months
|
6, 12 & 24 months
|
|
Change in Tegner score from baseline
Time Frame: 6 & 24 months
|
6 & 24 months
|
|
Change in SANE score from baseline
Time Frame: 6, 12 & 24 months
|
6, 12 & 24 months
|
|
Change in KOOS score from baseline
Time Frame: 6 & 24 months
|
6 & 24 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- RD-2016-04-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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