A Nanoscopic Second Look Into the Knee Joint

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Correlation between Estimated Percentage Meniscal Healing at Second Look Nanoscopic Arthroscopy and PROMIS Score. [Срок оценки: From baseline (preoperative assessment) to the postoperative second-look nanoscopic arthroscopy visit (3 to 24 months after the index meniscal repair procedure).]

Вторичные конечные точки (1)

• Estimated Percentage Healing Based on Comparison of Preoperative MRI Intraoperative Arthroscopic Images and Postoperative Nanoscopic Images. [Срок оценки: From the index procedure to postoperative second-look nanoscopic arthroscopy visit (3 to 24 months after the index procedure).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• University Medical Center of Southern Nevada — Las Vegas

Публикации

• 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
• 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
• 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
• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 29804955

Идентификаторы

NCT: NCT07709819 · IIRR-02382

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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