Non-Invasive Distractor During Knee Arthroscopy

The Taylor Collaboration

Status: Not yet enrolling

Conditions: Knee Arthritis; Knee Arthropathy

Treatments: Procedure: Manual Joint Distraction; Device: Non-Invasive Knee Joint Distraction

Study type: Interventional

Funder types: Other

Identifiers

NCT06458816

SFORP 136

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

Medial Non-Invasive Knee Distraction

Experimental group

Description:

medial aspect of knee with distraction device

Treatment:

Device: Non-Invasive Knee Joint Distraction

Lateral Non-Invasive Knee Distraction

Experimental group

Description:

lateral aspect of knee with distraction device

Treatment:

Device: Non-Invasive Knee Joint Distraction

Medial Manual Knee Distraction

Active Comparator group

Description:

medial aspect of knee with only manual distraction. no device.

Treatment:

Procedure: Manual Joint Distraction

Lateral Manual Knee Distraction

Active Comparator group

Description:

lateral aspect of knee with only manual distraction. no device.

Treatment:

Procedure: Manual Joint Distraction