A Nanoscopic Second Look Into the Knee Joint

July 11, 2026 updated by: Angelina Vera MD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Medical Center of Southern Nevada
        • Contact:
        • Contact:
        • Principal Investigator:
          • Angelina Vera, MD, FAAOS, FAANA
        • Sub-Investigator:
          • Christopher J Yergensen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postoperative Nanoscopic Knee Evaluation
Participants 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.
Procedure: Nanoscopic Arthroscopy of the Knee
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
From baseline (preoperative assessment) to the postoperative second-look nanoscopic arthroscopy visit (3 to 24 months after the index meniscal repair procedure).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Percentage Healing Based on Comparison of Preoperative MRI Intraoperative Arthroscopic Images and Postoperative Nanoscopic Images.
Time Frame: From the index procedure to postoperative second-look nanoscopic arthroscopy visit (3 to 24 months after the index procedure).
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.
From the index procedure to postoperative second-look nanoscopic arthroscopy visit (3 to 24 months after the index procedure).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angelina Vera MD

Collaborators

Arthrex, Inc.

Investigators

  • Principal Investigator: Angelina Vera, MD, FAAOS, FAANA, University Medical Center of Southern Nevada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2026

Primary Completion (Estimated)

May 20, 2028

Study Completion (Estimated)

May 20, 2029

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIRR-02382

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared outside of the study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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