Health TrialsbyHealthPanel

Non-Invasive Distractor During Knee Arthroscopy

ConditionsKnee ArthritisKnee Arthropathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Taylor Collaboration

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Non-Invasive Knee Joint Distraction

    Device

    Non-invasive Distraction device

  • Manual Joint Distraction

    Procedure/Surgery

    no device. manual distraction.

Treatment groups

14 Participants
are divided into 4 treatment groups
Group A: Medial Non-Invasive Knee DistractionExperimental treatment 1 intervention
Group B: Lateral Non-Invasive Knee DistractionExperimental treatment 1 intervention
Group C: Medial Manual Knee DistractionActive comparator 1 intervention
Group D: Lateral Manual Knee DistractionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Medial Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe

with manual distraction vs non-invasive distractor

Time frame
intraoperative
2

Lateral Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe

with manual distraction vs non-invasive distractor

Time frame
intraoperative

Secondary outcomes

1

Pre and Post operative pain scores

VAS

Time frame
preoperative and within 1 year after knee arthroscopy

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Taylor Collaboration

Lead sponsor

Wilma Chan Highland Hospital Campus

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: