Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis

September 14, 2023 updated by: Joseph Zimmerman, MD, Albany Medical College

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andrew D Posner, MD
  • Phone Number: 518-453-3079
  • Email: posnera@amc.edu

Study Contact Backup

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph P Zimmerman, MD
        • Sub-Investigator:
          • Andrew D Posner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unicompartmental OA or equivocal findings in XR
After obtaining informed consent, patients will undergo needle arthroscopy, performed in the operating room prior to undergoing arthroplasty
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
Other Names:
  • Needle Arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualization of unicompartmental or tricompartmental osteoarthritis
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Collaborators

Arthrex, Inc.

Investigators

  • Principal Investigator: Joseph P Zimmerman, MD, Albany Medical College
  • Study Director: Andrew D Posner, MD, Albany Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2021

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 2, 2024

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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