A Nanoscopic Second Look Into the Knee Joint

NCT07709819 | Recruiting FDA Device

• 1 other identifier: IIRR-02382
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Meniscal Tears

Keywords

Cartilage Repair; Cartilage Grafting; Meniscus Repair; Meniscus Trimming; Ligament Reconstruction; Cartilage Smoothing; Nanoscope; Nanoscopic Diagnostic Arthroscopy; Knee Joint

Outcome Measures

Primary Outcomes (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.

  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)

• Estimated Percentage Healing Based on Comparison of Preoperative MRI Intraoperative Arthroscopic Images and Postoperative Nanoscopic Images.

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

Study Arms (1)

Postoperative Nanoscopic Knee Evaluation

EXPERIMENTAL

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

Interventions

Nanoscopic Arthroscopy of the Knee PROCEDURE

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.

Postoperative Nanoscopic Knee Evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Angelina Vera MD: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 31533151 BACKGROUND

• 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.

  PMID: 32076938 BACKGROUND

• 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.

  PMID: 39694969 BACKGROUND

• 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.

  PMID: 29713647 BACKGROUND

• 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.

  PMID: 23948982 BACKGROUND

• 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.

  PMID: 21220542 BACKGROUND

• 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.

  PMID: 34708138 BACKGROUND

• 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.

  PMID: 29804955 BACKGROUND

• 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.

  PMID: 37105012 BACKGROUND

Study Officials

• Angelina Vera, MD, FAAOS, FAANA

  University Medical Center of Southern Nevada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert J Panganiban

CONTACT

(702) 383-7336; robert.panganiban@umcsn.com

Robert Bimbi, PhD

CONTACT

(702) 383-7302; robert.bimbi@umcsn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 17, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): May 20, 2028
• Study Completion (Estimated): May 20, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)