Recruiting

Observational Study

Sponsor:

Albany Medical College

Code:

NCT05002387

Conditions

Arthroplasty, Replacement, Knee

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NanoScope™ Operative Arthroscopy (Arthrex, Inc)

Study Details

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.

Conditions

Arthroplasty, Replacement, Knee

Study ID

NCT05002387

Start date

Sep 7, 2021

Status verified date

Sep, 2023

Completion date

Jan 2, 2024

Anticipated

Primary completion date

Jan 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

110 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Interventions

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

Primary outcome measure

  • Visualization of unicompartmental or tricompartmental osteoarthritis [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Andrew D Posner, MD

posnera@amc.edu

Principal Investigator:

Joseph P Zimmerman, MD

More Information

Sponsor

Albany Medical College

Last update posted

Sep 15, 2023

Last verified

Sep, 2023

Keywords

  • Unicompartmental Knee Arthroplasty
  • Needle Arthroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2023-09-15.