NuTech Affinity™ for the Treatment of Chondral Defects

NCT02837484 | Unknown

• 1 other identifier: RD2015-11-04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the long term effectiveness of a product used in knee surgery called Affinity™ Membrane.

Conditions

Chondral Lesions; Cartilage

Outcome Measures

Primary Outcomes (3)

• Objective cartilage repair measured by MRI scanning

  6 months, 12 months and 24 months

• Change from baseline for VAS scores

  3 months, 6 months, 12 months 18 months, and 24 months

• Change from baseline of pain and functions scores on KOOS questionaire

  3 months, 6 months, 12 months, 18 months and 24 months

Secondary Outcomes (2)

• Changes in patient-reported outcomes (PRO) questionnaires from baseline including IKDC (International Knee Documentation Committee)

  3 months, 6 months, 12 months, 18 months and 24 months

• Histological assessment of optional cartilage biopsies

  24 months

Study Arms (1)

NuTech Affinity™ Membrane

OTHER

Sharp dissection of the defect will be performed being careful not to violate the subchondral bone sparing the calcified cartilage layer. After hemostasis is reached, the defect will be treated with an Affinity™ patch stabilized with fibrin glue.

Other: NuTech Affinity™ Membrane

Interventions

NuTech Affinity™ Membrane OTHER

NuTech Affinity™ Membrane is an aseptically produced hypothermically stored amniotic membrane patch.

NuTech Affinity™ Membrane

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 (Institutional Review Board) 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 or uncontained lesion(s) and equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle or trochlear groove and OCD (Osteohondritis dissecans) lesions (Grade 4a) with healed bone base, which is non-sclerotic and no loss of bone greater than 6mm measured from the surrounding subchondral plate. Original pretreatment arthroscopic confirmation indicates that one or two lesion(s) are equal to an ICRS (Internation Cartilage Repair Society) 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).
• Has peripheral cartilage debridement to healthy cartilage that results in a lesion (s) with an area of \> or = 1cm \^2 and \< or = 5 cm\^2.
• PCL (Posterior Cruciate Ligament), LCL (Lateral Collateral Ligament) and MCL (Medical Collateral Ligament) in the affected knee are stable and the ACL (Anterior Cruciate Ligament) is stable or can be stabilized as a concomitant procedure.
• Ipsilateral knee compartment has intact menisci (or requires partial meniscectomy resulting in stable menisci). No less than 60 degrees meniscal volume retained.
• 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 visit through 24 months.
• Alignment: Mechanical axis must be no more than 6 degrees from neutral.
• Must be at least 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 6 mm deep measured 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 (1)

New Mexico Orthopaedics

Albuquerque, New Mexico, 87106, United States

Location

Related Publications (1)

• Tabet SK, Kimmerling KA, Hale GJ, Munson NR, Mowry KC. Hypothermically Stored Amniotic Membrane for the Treatment of Cartilage Lesions: A Single-Arm Prospective Study with 2-Year Follow-Up. Cartilage. 2022 Jan-Mar;13(1):19476035211072213. doi: 10.1177/19476035211072213.

  PMID: 35073769 DERIVED

Study Officials

• Sam Tabet, MD

  New Mexico Orthopaedic Associates

  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: July 14, 2016
• First Posted: July 19, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)