A Nanoscopic Second Look Into the Knee Joint

ConditionMeniscal Tears

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAngelina Vera MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Nanoscopic Arthroscopy of the Knee
Procedure/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.

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Postoperative Nanoscopic Knee EvaluationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Angelina Vera MD

Lead sponsor

University Medical Center of Southern Nevada

Sponsor institution

Arthrex, Inc.

Collaborator

Source ClinicalTrials.gov

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