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Meniscal TearsNCT07709819

A Nanoscopic Second Look Into the Knee Joint

A study testing Nanoscopic Arthroscopy of the Knee in people with Meniscal Tears, run by Angelina Vera MD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to look at how well different surgeries heal over time in patients that have previously undergone arthroscopic knee interventions. These procedures may include cartilage repair or grafting, meniscus repair or trimming, ligament reconstruction, cartilage smoothing, and treatments such… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meniscal Tears
What is being tested?
Nanoscopic Arthroscopy of the Knee
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
20 May 2026to 20 May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 years and older who have undergone or are scheduled to undergo arthroscopic knee intervention.
  • Eligible procedures include meniscus repair, biocartilage procedures, and other arthroscopic biologic interventions of the knee
  • Ability to understand and provide informed consent
  • Agreement to undergo postoperative in-clinic second-look nanoscopic arthroscopy of the knee.

Who cannot join

  • Refusal to undergo postoperative in-clinic second-look nanoscopic arthroscopy of the knee.
  • Inability to provide informed consent.
  • Individuals who are not yet adults (infants, children, teenagers).
  • Pregnant women
  • Prisoners

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Robert Bimbi, PhD contact

(702) 383-7302

robert.bimbi@umcsn.com

United States1 site, 1 recruiting
  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

    Robert Panganiban, 702-383-7336, robert.panganiban@umcsn.com

    Robert Bimbi, PhD, 702-383-7302, robert.bimbi@umcsn.com

    Recruiting

Other trials in United States

About this study

Official title: A Nanoscopic Second Look Into the Knee Joint, What Have We Learned?

The goal of this clinical trial is to look at how well different surgeries heal over time in patients that have previously undergone arthroscopic knee interventions. These procedures may include cartilage repair or grafting, meniscus repair or trimming, ligament reconstruction, cartilage smoothing, and treatments such as amniotic tissue or platelet rich plasma (PRP).

Using a very small camera called a nanoarthroscope, doctors will take a "second look" inside the knee after surgery to see how it has healed. These findings will be compared to patient-reported outcomes, such as pain and function scores, as well as images taken during the original surgery.

The goal is to determine whether this second look provides useful information that can help guide recovery and future care.

Read the detailed description

The purpose of this study is to examine the healing potential and mid to long term outcomes of various orthopaedic surgical interventions within the knee joint through a novel modality, bedside nanoarthroscopy. These interventions include but are not limited to: autocartilage grafting, biocartilage grafting, meniscus repair, partial meniscectomy, ligament reconstruction, chondroplasty, as well as amnion placement and platelet rich plasma injection. The "second look" nanoscopic outcomes will be compared to the gold standard patient reported outcome measures as well as time of surgery arthroscopic images.

The individuals recruited for the study will participate in one single clinic visit which will entail a nanoscopic evaluation of their knee. Patients will be asked to fill out a standardized battery of validated patient reported outcome measure surveys and will be consented to undergo a "nanoscopic second look" into their knee joint using a nanoscope in the clinic setting. This procedure involves inserting a nanoscopic camera into the knee joint for diagnostic purposes. The nanoscope is no larger than an 18-gauge needle which is routinely used in clinic and hospital settings to deliver injections and perform arthrocentesis.

For the patients who agree to participate, the following information will be collected from them and from chart review. Injury, procedure performed, date of procedure, and time since procedure. Key images from preoperative MRI will also be accessed along with arthroscopic images from the time of surgery. Nanoscopic images and patient reported outcome measures as described above will also be collected and secured.

Using a comparison of key slices of preoperative MRI, time of surgery arthroscopic images, and nanoscopic second look images, a percentage of healing will be estimated and recorded. This number will then be compared against scores on the patient reported outcome surveys. This will be repeated for all patients enrolled in the study and statistical analysis will be performed to determine if there is a correlation between patient reported outcome scores and percentage of healing at nanoscopic second look.

Secondary outcomes will also be analyzed including success/failure of any biologic augmentation type procedures such as cartilage allograft or autograft and/or amniotic membrane use by comparing time of surgery images to nanoscopic second look images

It will take approximately 2 years to enroll all study subjects and approximately 3 years to complete this study.

Conditions
Meniscal Tears
Being tested
Nanoscopic Arthroscopy of the Knee
Keywords
Cartilage Repair, Cartilage Grafting, Meniscus Repair, Meniscus Trimming, Ligament Reconstruction, Cartilage Smoothing, Nanoscope, Nanoscopic Diagnostic Arthroscopy, Knee Joint

What participants receive

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

  • Nanoscopic Arthroscopy of the KneeProcedure or surgery

    Participants who agree to participate will undergo a postoperative in-clinic nanoscopic arthroscopy of the knee at a routine follow-up visit. A small nanoscope will be inserted into the knee joint in a clinic setting to obtain images that will be used for comparison to the arthroscopic images taken from their surgery and preoperative MRI images. The estimated healing will then be recorded and compared with patient reported outcome survey scores.

Study groups in NCT07709819
Study groupRoleWhat they receive
Postoperative Nanoscopic Knee EvaluationExperimentalParticipants who consent will undergo an in-clinic postoperative nanoscopic arthroscopy of the knee at a routine follow-up visit. Images obtained during nanoscopic evaluation will be compared with preoperative MRI and intraoperative arthroscopic images to estimate healing and findings will be correlated with patient-reported outcome measures.
Receives: Procedure: Nanoscopic Arthroscopy of the Knee

What is being measured

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

  1. Correlation between Estimated Percentage Meniscal Healing at Second Look Nanoscopic Arthroscopy and PROMIS Score.

    The primary outcome measure is the correlation between estimated meniscal repair healing and change from baseline in PROMIS Physical Function T-Score. Meniscal healing will be assessed using postoperative second-look nanoscopic arthroscopy images obtained 3 to 24 months after the index procedure. The Principal Investigator or delegated trained investigator will visually estimate healing of the original repair site from 0% to 100%, where 0% indicates no observable healing and 100% indicates complete healing with continuous, stable tissue bridging. PROMIS Physical Function will be assessed using the PROMIS Bank v2.0 Physical Function CAT at baseline and at the postoperative nanoscopic visit. The relationship between estimated healing percentage and PROMIS Physical Function T-Score change will be assessed using Spearman's rank correlation coefficient.

    Measured: From baseline (preoperative assessment) to the postoperative second-look nanoscopic arthroscopy visit (3 to 24 months after the index meniscal repair procedure).

Secondary outcomes (1)
  1. Estimated Percentage Healing Based on Comparison of Preoperative MRI Intraoperative Arthroscopic Images and Postoperative Nanoscopic Images.

    The secondary outcome measure is the estimated percentage of meniscal repair healing based on side-by-side review of intraoperative arthroscopic images and postoperative second-look nanoscopic arthroscopy images. Images will be reviewed by the Principal Investigator or delegated trained investigator using protocol-defined healing criteria. Healing will be visually estimated as the proportion of the original meniscal repair site demonstrating healing and recorded as a percentage from 0% to 100%, where 0% indicates no observable healing and 100% indicates complete healing. Healing percentage will be calculated at the postoperative second-look nanoscopic arthroscopy visit, occurring 3 to 24 months after the index procedure.

    Measured: From the index procedure to postoperative second-look nanoscopic arthroscopy visit (3 to 24 months after the index procedure).

Timeline

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

  1. First posted17 Jul 2026
  2. Study start20 May 2026
  3. Primary completion20 May 2028 (estimated)
  4. Study completion20 May 2029 (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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07709819
Sponsor's protocol ID
IIRR-02382
Status last verified
Jul 2026
First submitted
17 Jun 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data will not be shared outside of the study team.

Publications

  • Farr J, Gomoll AH, Yanke AB, Strauss EJ, Mowry KC; ASA Study Group. A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. J Knee Surg. 2019 Nov;32(11):1143-1154. doi: 10.1055/s-0039-1696672. Epub 2019 Sep 18.

    PubMed 31533151
  • Huddleston HP, Cohn MR, Haunschild ED, Wong SE, Farr J, Yanke AB. Amniotic Product Treatments: Clinical and Basic Science Evidence. Curr Rev Musculoskelet Med. 2020 Apr;13(2):148-154. doi: 10.1007/s12178-020-09614-2.

    PubMed 32076938
  • Utrilla GS, Degano IR, D'Ambrosi R. Efficacy of platelet-rich plasma in meniscal repair surgery: a systematic review of randomized controlled trials. J Orthop Traumatol. 2024 Dec 18;25(1):63. doi: 10.1186/s10195-024-00799-7.

    PubMed 39694969
  • Kaminski R, Kulinski K, Kozar-Kaminska K, Wielgus M, Langner M, Wasko MK, Kowalczewski J, Pomianowski S. A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma. Biomed Res Int. 2018 Mar 11;2018:9315815. doi: 10.1155/2018/9315815. eCollection 2018.

    PubMed 29713647
  • Pujol N, Tardy N, Boisrenoult P, Beaufils P. Magnetic resonance imaging is not suitable for interpretation of meniscal status ten years after arthroscopic repair. Int Orthop. 2013 Dec;37(12):2371-6. doi: 10.1007/s00264-013-2039-6. Epub 2013 Aug 15.

    PubMed 23948982
  • Miao Y, Yu JK, Ao YF, Zheng ZZ, Gong X, Leung KK. Diagnostic values of 3 methods for evaluating meniscal healing status after meniscal repair: comparison among second-look arthroscopy, clinical assessment, and magnetic resonance imaging. Am J Sports Med. 2011 Apr;39(4):735-42. doi: 10.1177/0363546510388930. Epub 2011 Jan 10.

    PubMed 21220542
  • Dai W, Leng X, Wang J, Hu X, Ao Y. Second-Look Arthroscopic Evaluation of Healing Rates After Arthroscopic Repair of Meniscal Tears: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2021 Oct 22;9(10):23259671211038289. doi: 10.1177/23259671211038289. eCollection 2021 Oct.

    PubMed 34708138
  • Gill TJ, Safran M, Mandelbaum B, Huber B, Gambardella R, Xerogeanes J. A Prospective, Blinded, Multicenter Clinical Trial to Compare the Efficacy, Accuracy, and Safety of In-Office Diagnostic Arthroscopy With Magnetic Resonance Imaging and Surgical Diagnostic Arthroscopy. Arthroscopy. 2018 Aug;34(8):2429-2435. doi: 10.1016/j.arthro.2018.03.010. Epub 2018 May 24.

    PubMed 29804955
  • Burt J, Smith V, Gee CW, Clarke JV, Hall AJ. The role of outpatient needle arthroscopy in the diagnosis and management of musculoskeletal complaints: A systematic review of the Arthrex NanoScope. Knee. 2023 Jun;42:246-257. doi: 10.1016/j.knee.2023.04.003. Epub 2023 Apr 25.

    PubMed 37105012

Questions about this trial

What is this clinical trial studying?

A study testing Nanoscopic Arthroscopy of the Knee in people with Meniscal Tears, run by Angelina Vera MD 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robert J Panganiban ((702) 383-7336, robert.panganiban@umcsn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between Estimated Percentage Meniscal Healing at Second Look Nanoscopic Arthroscopy and PROMIS Score. (time frame: From baseline (preoperative assessment) to the postoperative second-look nanoscopic arthroscopy visit (3 to 24 months after the index meniscal repair procedure).). 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 NCT07709819, which also lists 9 linked publications.

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 17 Jul 2026.

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