Non-Invasive Distractor During Knee Arthroscopy

June 10, 2024 updated by: The Taylor Collaboration

The Utility of a Non-Invasive Distractor During Arthroscopy of the Knee Joint

Patients will be prospectively recruited for knee joint distraction who are undergoing knee arthroscopy. Patient demographics, operative factors, and rates of medical comorbidities will be collected and evaluated. Intraoperative arthroscopic images will be evaluated by the attending Orthopaedic surgeon with standard and testing mechanism and a measuring device will be used to measure the distance between the femur and tibia in the medial and lateral compartments.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

14

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

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults ≥ 18 years of age who have capacity to provide informed consent. Eligible participants will include existing patients of Dr. DiStefano who are scheduled to undergo knee arthroscopic surgery to address meniscal pathology. Study risks, benefits and description will be provided and informed consent will be obtained.

Exclusion Criteria:

  • Patients with prior history of neurovascular deficiency or history of prior injury
  • Patients with a prior history of knee surgery
  • Patients with diagnosed knee ligament laxity or knee instability.
  • Patients that are not cleared for knee arthroscopy

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: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medial Non-Invasive Knee Distraction
medial aspect of knee with distraction device
Device: Non-Invasive Knee Joint Distraction
Non-invasive Distraction device
Experimental: Lateral Non-Invasive Knee Distraction
lateral aspect of knee with distraction device
Device: Non-Invasive Knee Joint Distraction
Non-invasive Distraction device
Active Comparator: Medial Manual Knee Distraction
medial aspect of knee with only manual distraction. no device.
Procedure: Manual Joint Distraction
no device. manual distraction.
Active Comparator: Lateral Manual Knee Distraction
lateral aspect of knee with only manual distraction. no device.
Procedure: Manual Joint Distraction
no device. manual distraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medial Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
Time Frame: intraoperative
with manual distraction vs non-invasive distractor
intraoperative
Lateral Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
Time Frame: intraoperative
with manual distraction vs non-invasive distractor
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre and Post operative pain scores
Time Frame: preoperative and within 1 year after knee arthroscopy
VAS
preoperative and within 1 year after knee arthroscopy

Collaborators and Investigators

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

Sponsor

The Taylor Collaboration

Collaborators

Wilma Chan Highland Hospital Campus

Investigators

  • Study Director: Edward De Mayo, MD, Attending Orthopaedic Surgeon

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

Helpful Links

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFORP 136

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.

Clinical Trials on Knee Arthritis

Clinical Trials on Non-Invasive Knee Joint Distraction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe