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Chondral LesionsNCT02837484

NuTech Affinity™ for the Treatment of Chondral Defects

A study testing NuTech Affinity™ Membrane in people with Chondral Lesions and Cartilage, run by NuTech Medical, Inc at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Chondral Lesions, Cartilage
What is being tested?
NuTech Affinity™ Membrane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
May 2016to Oct 2020
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 (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
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  • 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.

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 6 mm deep measured 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 received within the past three months intra-articular hyaluronic acid therapy or cortisone injections in the index knee.
  • Prior realignment surgery in the affected knee within the past 6 months.
  • Failed microfracture treatment performed less than 12-months before inclusion visit.
  • 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.
  • 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, or has a tendency of claustrophobia. Tattoos that may contain iron-based dyes.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New Mexico Orthopaedics

    Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Official title: The NuTech Affinity™ Membrane Product Evaluation for the Treatment of Chondral Defects

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

Read the detailed description

This is a one-arm prospective, non-randomized, longitudinal study with up to 10 patients from one orthopaedic clinic in the United States. Patients will be treated with Affinity™ a hypothermically preserved amniotic membrane.

Being tested
NuTech Affinity™ Membrane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NuTech Affinity™ MembraneOther

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

Study groups in NCT02837484
Study groupRoleWhat they receive
NuTech Affinity™ MembraneOtherSharp 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.
Receives: Other: NuTech Affinity™ Membrane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective cartilage repair measured by MRI scanning

    Measured: 6 months, 12 months and 24 months

  2. Change from baseline for VAS scores

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

  3. Change from baseline of pain and functions scores on KOOS questionaire

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

Secondary outcomes (2)

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

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

  2. Histological assessment of optional cartilage biopsies

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionOct 2020 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02837484
Sponsor's protocol ID
RD2015-11-04
Status last verified
Jan 2020
First submitted
14 Jul 2016
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35073769

Questions about this trial

What is this clinical trial studying?

A study testing NuTech Affinity™ Membrane in people with Chondral Lesions and Cartilage, run by NuTech Medical, Inc at 1 site 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 26 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: status not confirmed, 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 1 site 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?

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?

Objective cartilage repair measured by MRI scanning (time frame: 6 months, 12 months and 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02837484, which also lists 1 linked publication.

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.

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