ReNu™ Marrow Stimulation Augmentation

NCT03036878 | Terminated

• 1 other identifier: RD-2016-04-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for osteochondral lesions

Conditions

Osteochondral Defect

Keywords

Osteochondral; Marrow Stimulation; ReNu

Outcome Measures

Primary Outcomes (2)

• Change in KOOS score from baseline

  1 Year

• Change in Tegner score from baseline

  1 Year

Secondary Outcomes (4)

• Change in VAS score from baseline

  6, 12 & 24 months

• Change in Tegner score from baseline

  6 & 24 months

• Change in SANE score from baseline

  6, 12 & 24 months

• Change in KOOS score from baseline

  6 & 24 months

Study Arms (1)

ReNu Injection

EXPERIMENTAL

Injection of ReNu allograft into the joint capsule.

Other: ReNu

Interventions

ReNu OTHER

ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.

ReNu Injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NuTech Medical, Inc: lead
• Organogenesis: collaborator

Study Sites (2)

Orthoindy

Indianapolis, Indiana, 46143, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Study Officials

• Jack Farr, MD

  OrthoIndy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: January 30, 2017
• Study Start: February 7, 2017
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)