Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis

NCT05002387 | Unknown DMC FDA Device

• 1 other identifier: 6115
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Plain radiographs and MRI play an important role in the diagnosis of intra-articular knee pathology and can be used to guide treatment decisions. These imaging modalities however have several limitations which can lead to misdiagnosis, incorrect treatment decisions, and suboptimal patient care. The gold standard for confirmation of intra-articular knee pathology is formal diagnostic knee arthroscopy. Diagnostic knee arthroscopy must be performed in the operating room under general anesthesia, which adds both risk and cost to the patient. In contrast to formal diagnostic arthroscopy which uses a 4.8mm arthroscope, needle arthroscopy (NA) uses a 1.9mm nano-arthroscope. NA with a nano-arthroscope is a technique which allows direct high quality intra-articular visualization to be obtained without general anesthesia, and can be performed either in the office or the operating room (OR). One specific application for this technology is in the evaluation of patients who are being considered for either a total knee arthroplasty (TKA) or a unicompartmental knee arthroplasty (UKA). An essential component of the pre-operative work-up is determining if the patient has isolated unicompartmental knee osteoarthritis (OA) or more widespread tricompartmental knee OA. This distinction is essential as each condition is treated differently; isolated unicompartmental knee OA is treated with a UKA while tricompartmental OA is treated with TKA. Our primary objective is to determine if NA is an effective, safe, and cost effective tool to confirm the presence of unicompartmental OA and thus guide patient management in the decision to perform UKA or TKA. Disclosure: This study is sponsored by Arthrex Inc, the manufacturer of the NanoScope™ operative arthroscopy imaging system which will be used in the study. Arthrex will provide NanoScope™ supplies only; no direct monetary funding will be provided.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Unicompartmental Knee Arthroplasty; Needle Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Visualization of unicompartmental or tricompartmental osteoarthritis

  To determine if needle arthroscopy is an effective tool to confirm the presence of unicompartmental knee OA, which had been initially suggested on standard weight bearing knee radiographs. Findings on NA will be compared to preoperative diagnosis from standard weight bearing radiographs.

  1 day

Study Arms (1)

Unicompartmental OA or equivocal findings in XR

EXPERIMENTAL

After obtaining informed consent, patients will undergo needle arthroscopy, performed in the operating room prior to undergoing arthroplasty

Device: NanoScope™ Operative Arthroscopy (Arthrex, Inc)

Interventions

NanoScope™ Operative Arthroscopy (Arthrex, Inc) DEVICE

Needle arthroscopy will be performed in the operating room to visual the medial, lateral, and patellofemoral compartments prior to undergoing either unicompartmental or total knee arthroplasty

Also known as: Needle Arthroscopy

Unicompartmental OA or equivocal findings in XR

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English fluency and literacy
• Able to provide informed consent
• Males or females, \> 18 years of age and \< 89
• Indicated for unicompartmental knee arthroplasty based on a series of existing weight bearing knee plain radiographs
• Have equivocal weight bearing knee radiographs, in which the indication for UKA vs. TKA is not clear
• Meet the following criteria: no inflammatory arthritis, intact Anterior cruciate ligament, no fixed varus deformity \> 10 degrees, no fixed valgus deformity \> 5 degrees, knee range of motion \> 90 degrees, no patellofemoral arthritis

You may not qualify if:

• Males or females \< 18 years of age and \>89
• Prisoners
• Patient who have existing radiographic evidence of tricompartmental OA
• Patients with inflammatory arthritis, anterior cruciate ligament deficiency, fixed varus deformity \> 10 degrees, fixed valgus deformity \> 5 degrees, knee range of motion \< 90 degrees, patellofemoral arthritis

Sponsors & Collaborators

• Albany Medical College: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Related Publications (12)

• Zhang K, Crum RJ, Samuelsson K, Cadet E, Ayeni OR, de Sa D. In-Office Needle Arthroscopy: A Systematic Review of Indications and Clinical Utility. Arthroscopy. 2019 Sep;35(9):2709-2721. doi: 10.1016/j.arthro.2019.03.045. Epub 2019 Aug 12.

  PMID: 31416656 BACKGROUND

• Halbrecht JL, Jackson DW. Office arthroscopy: a diagnostic alternative. Arthroscopy. 1992;8(3):320-6. doi: 10.1016/0749-8063(92)90062-g.

  PMID: 1418203 BACKGROUND

• McMillan S, Saini S, Alyea E, Ford E. Office-Based Needle Arthroscopy: A Standardized Diagnostic Approach to the Knee. Arthrosc Tech. 2017 Jul 24;6(4):e1119-e1124. doi: 10.1016/j.eats.2017.03.031. eCollection 2017 Aug.

  PMID: 29354406 BACKGROUND

• Patel KA, Hartigan DE, Makovicka JL, Dulle DL 3rd, Chhabra A. Diagnostic Evaluation of the Knee in the Office Setting Using Small-Bore Needle Arthroscopy. Arthrosc Tech. 2017 Dec 11;7(1):e17-e21. doi: 10.1016/j.eats.2017.08.044. eCollection 2018 Jan.

  PMID: 29379709 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

• Chapman GL, Amin NH. The Benefits of an In-Office Arthroscopy in the Diagnosis of Unresolved Knee Pain. Case Rep Orthop. 2018 Jan 21;2018:6125676. doi: 10.1155/2018/6125676. eCollection 2018.

  PMID: 29992071 BACKGROUND

• Deirmengian CA, Dines JS, Vernace JV, Schwartz MS, Creighton RA, Gladstone JN. Use of a Small-Bore Needle Arthroscope to Diagnose Intra-Articular Knee Pathology: Comparison With Magnetic Resonance Imaging. Am J Orthop (Belle Mead NJ). 2018 Feb;47(2). doi: 10.12788/ajo.2018.0007.

  PMID: 29494711 BACKGROUND

• Voigt JD, Mosier M, Huber B. In-office diagnostic arthroscopy for knee and shoulder intra-articular injuries its potential impact on cost savings in the United States. BMC Health Serv Res. 2014 May 5;14:203. doi: 10.1186/1472-6963-14-203.

  PMID: 24885678 BACKGROUND

• Amin N, McIntyre L, Carter T, Xerogeanes J, Voigt J. Cost-Effectiveness Analysis of Needle Arthroscopy Versus Magnetic Resonance Imaging in the Diagnosis and Treatment of Meniscal Tears of the Knee. Arthroscopy. 2019 Feb;35(2):554-562.e13. doi: 10.1016/j.arthro.2018.09.030.

  PMID: 30712631 BACKGROUND

• Hamilton TW, Pandit HG, Lombardi AV, Adams JB, Oosthuizen CR, Clave A, Dodd CA, Berend KR, Murray DW. Radiological Decision Aid to determine suitability for medial unicompartmental knee arthroplasty: development and preliminary validation. Bone Joint J. 2016 Oct;98-B(10 Supple B):3-10. doi: 10.1302/0301-620X.98B10.BJJ-2016-0432.R1.

  PMID: 27694509 BACKGROUND

• McMillan S, Chhabra A, Hassebrock JD, Ford E, Amin NH. Risks and Complications Associated With Intra-articular Arthroscopy of the Knee and Shoulder in an Office Setting. Orthop J Sports Med. 2019 Sep 27;7(9):2325967119869846. doi: 10.1177/2325967119869846. eCollection 2019 Sep.

  PMID: 31632993 BACKGROUND

• Slattery C, Kweon CY. Classifications in Brief: Outerbridge Classification of Chondral Lesions. Clin Orthop Relat Res. 2018 Oct;476(10):2101-2104. doi: 10.1007/s11999.0000000000000255. No abstract available.

  PMID: 29533246 BACKGROUND

Study Officials

• Joseph P Zimmerman, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

• Andrew D Posner, MD

  Albany Medical College

  STUDY DIRECTOR

Central Study Contacts

Andrew D Posner, MD

CONTACT

518-453-3079; posnera@amc.edu

Joseph P Zimmerman, MD

CONTACT

518-453-3079; JZimmerman@caportho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joseph Zimmerman, MD, Attending Orthopaedic Surgeon, Department of Surgery, Division of Orthopaedic Surgery, Albany Medical College

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 12, 2021
• Study Start: September 7, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 2, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)