RECRUITING

Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-09-07
Study Completion:2024-01-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05002387

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.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English fluency and literacy
  2. * Able to provide informed consent
  3. * Males or females, \> 18 years of age and \< 89
  4. * Indicated for unicompartmental knee arthroplasty based on a series of existing weight bearing knee plain radiographs
  5. * Have equivocal weight bearing knee radiographs, in which the indication for UKA vs. TKA is not clear
  6. * 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
  1. * Males or females \< 18 years of age and \>89
  2. * Prisoners
  3. * Patient who have existing radiographic evidence of tricompartmental OA
  4. * 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

Contacts and Locations

Study Contact

Andrew D Posner, MD
CONTACT
518-453-3079
posnera@amc.edu
Joseph P Zimmerman, MD
CONTACT
518-453-3079
JZimmerman@caportho.com

Principal Investigator

Joseph P Zimmerman, MD
PRINCIPAL_INVESTIGATOR
Albany Medical College
Andrew D Posner, MD
STUDY_DIRECTOR
Albany Medical College

Study Locations (Sites)

Albany Medical Center
Albany, New York, 12208
United States

Collaborators and Investigators

Sponsor: Albany Medical College

  • Joseph P Zimmerman, MD, PRINCIPAL_INVESTIGATOR, Albany Medical College
  • Andrew D Posner, MD, STUDY_DIRECTOR, Albany Medical College

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 Registration Dates

Study Start Date2021-09-07
Study Completion Date2024-01-02

Study Record Updates

Study Start Date2021-09-07
Study Completion Date2024-01-02

Terms related to this study

Keywords Provided by Researchers

  • Unicompartmental Knee Arthroplasty
  • Needle Arthroscopy

Additional Relevant MeSH Terms

  • Arthroplasty, Replacement, Knee