Clinical trial NCT06458816: Non-Invasive Distractor During Knee Arthroscopy
Official title: The Utility of a Non-Invasive Distractor During Arthroscopy of the Knee Joint
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Arthritis
Knee Arthropathy
Keywords: arthroscopy
knee joint distraction
non invasive
sports medicine
Lead sponsor: The Taylor Collaboration
Sponsor class: OTHER
Collaborators: name: Wilma Chan Highland Hospital Campus
First posted: 2024-06-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective cohort study the utility of a non-invasive distractor during arthroscopy. We hypothesize that the non-invasive distractor in conjunction with the DeMayo leg holder will provide superior medial and lateral compartment distraction with greater stability of the operative leg compared to standard manual arthroscopy techniques.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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: 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

Primary outcomes:
measure: Medial Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
timeFrame: intraoperative
measure: Lateral Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
timeFrame: intraoperative
Secondary outcomes:
measure: Pre and Post operative pain scores
timeFrame: preoperative and within 1 year after knee arthroscopy
Other outcomes:
Locations:
Study officials:
affiliation: Attending Orthopaedic Surgeon
name: Edward De Mayo, MD
role: STUDY_DIRECTOR
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