Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

A Prospective Pilot Study Comparing Diagnostic Knee Needle Arthroscopy (NA) With Standard Weight Bearing Knee Radiographic in Predicting Unicompartmental Knee Osteoarthritis Prior to Unicompartmental Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05002387
• Other study ID #: 6115
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: January 2, 2024

Study information

• Verified date: September 2023
• Source: Albany Medical College
• Contact: Andrew D Posner, MD
• Phone: 518-453-3079
• Email: posnera[@]amc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A prospective study of patients being evaluated for UKA/TKA will be performed. The study will include two groups: 1) patients who are diagnosed with isolated unicompartmental knee OA by standard weight bearing radiographs and are likely indicated for UKA and 2) patients for whom the standard weight bearing radiographs are equivocal for the diagnosis of unicompartmental OA vs. tricompartmental OA. The preoperative radiographic evaluation prior to UKA or TKA includes a series of standard weight bearing knee radiographs which historically have been used to differentiate between unicompartmental OA and tricompartmental OA. This series of radiographs includes weight bearing AP, lateral, skyline, Rosenberg, and valgus stress views.

Subsequently, after obtaining informed consent, both groups of patients will undergo NA, performing in the operating room on the day of arthroplasty, prior to surgery beginning. NA will be performed with a 1.9mm nano arthroscope, as part of their diagnostic pre-arthroplasty evaluation, in lieu of standard arthroscopy, which utilizes a 4.8mm arthroscope. NA will directly visualize the articular cartilage in the medial, lateral, and patellofemoral compartments of the knee. Cartilage will be arthroscopically graded according to the Outerbridge Classification of chondral lesions. Patients with visualized Grade IV full-thickness cartilage loss with exposed subchondral bone isolated to either the medial or lateral compartment, with Grade 0-II lesions in the contralateral and / or patellofemoral compartments, will undergo a medial or lateral UKA, respectively. Patients with a Grade IV lesion in the medial or lateral compartment, with asymptomatic Grade III lesions in the contralateral and / or patellofemoral compartments will undergo a medial or lateral UKA, respectively. Patients with a Grade IV lesion in the medial or lateral compartment, with symptomatic Grade III lesions in the contralateral and / or patellofemoral compartments will undergo TKA. Patients with a Grade IV lesion in the medial or lateral compartment, with Grade IV lesions in the contralateral and / or patellofemoral compartments will undergo TKA.

Intraoperative findings at the time of arthroplasty will serve at the gold standard to which the NA findings will be compared. Furthermore, the diagnosis obtained from NA will be compared to the diagnosis obtained from preoperative weight bearing radiographs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• NanoScope™ Operative Arthroscopy (Arthrex, Inc)
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

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albany Medical College	Arthrex, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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