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Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis

Primary Purpose

Arthroplasty, Replacement, Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NanoScope™ Operative Arthroscopy (Arthrex, Inc)
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arthroplasty, Replacement, Knee focused on measuring Unicompartmental Knee Arthroplasty, Needle Arthroscopy

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albany Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Unicompartmental OA or equivocal findings in XR

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2021
Last Updated
September 14, 2023
Sponsor
Albany Medical College
Collaborators
Arthrex, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05002387
Brief Title
Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
Collaborators
Arthrex, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee
Keywords
Unicompartmental Knee Arthroplasty, Needle Arthroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unicompartmental OA or equivocal findings in XR
Arm Type
Experimental
Arm Description
After obtaining informed consent, patients will undergo needle arthroscopy, performed in the operating room prior to undergoing arthroplasty
Intervention Type
Device
Intervention Name(s)
NanoScope™ Operative Arthroscopy (Arthrex, Inc)
Other Intervention Name(s)
Needle Arthroscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
Visualization of unicompartmental or tricompartmental osteoarthritis
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew D Posner, MD
Phone
518-453-3079
Email
posnera@amc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph P Zimmerman, MD
Phone
518-453-3079
Email
JZimmerman@caportho.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph P Zimmerman, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew D Posner, MD
Organizational Affiliation
Albany Medical College
Official's Role
Study Director
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew D Posner, MD
Email
posnera@amc.edu
First Name & Middle Initial & Last Name & Degree
Joseph P Zimmerman, MD
First Name & Middle Initial & Last Name & Degree
Andrew D Posner, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31416656
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.
Results Reference
background
PubMed Identifier
1418203
Citation
Halbrecht JL, Jackson DW. Office arthroscopy: a diagnostic alternative. Arthroscopy. 1992;8(3):320-6. doi: 10.1016/0749-8063(92)90062-g.
Results Reference
background
PubMed Identifier
29354406
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.
Results Reference
background
PubMed Identifier
29379709
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.
Results Reference
background
PubMed Identifier
29804955
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.
Results Reference
background
PubMed Identifier
29992071
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.
Results Reference
background
PubMed Identifier
29494711
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.
Results Reference
background
PubMed Identifier
24885678
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.
Results Reference
background
PubMed Identifier
30712631
Citation
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.
Results Reference
background
PubMed Identifier
27694509
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.
Results Reference
background
PubMed Identifier
31632993
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.
Results Reference
background
PubMed Identifier
29533246
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.
Results Reference
background

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Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis

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