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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05002387
Other study ID # 6115
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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:

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Study Design


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)

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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
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