Non-Invasive Distractor During Knee Arthroscopy

Not Applicable

Not yet recruiting

• Conditions: Knee Arthritis; Knee Arthropathy
• Interventions: Procedure: Manual Joint Distraction; Device: Non-Invasive Knee Joint Distraction

• Registration Number: NCT06458816
• Lead Sponsor: The Taylor Collaboration

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medial Manual Knee Distraction	Manual Joint Distraction	medial aspect of knee with only manual distraction. no device.
Medial Non-Invasive Knee Distraction	Non-Invasive Knee Joint Distraction	medial aspect of knee with distraction device
Lateral Non-Invasive Knee Distraction	Non-Invasive Knee Joint Distraction	lateral aspect of knee with distraction device
Lateral Manual Knee Distraction	Manual Joint Distraction	lateral aspect of knee with only manual distraction. no device.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pre and Post operative pain scores	preoperative and within 1 year after knee arthroscopy	VAS