Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques

Wake Forest University Health Sciences36 enrolled

Overview

This randomized, controlled clinical trial will compare the outcomes of single portal versus two portal techniques in patients who have meniscus or articular cartilage pathology. The study hypothesis is that patients who undergo single portal arthroscopy will have less pain post-operatively, use less pain medication, and have a higher International Knee Documentation Committee (IKDC) score at six months and one year compared to patients who undergo traditional two portal knee arthroscopy.

Background, Rationale and Context Knee arthroscopy procedures provide a minimally invasive method to assess the status of the knee joint in order to repair injuries of the meniscus and articular cartilage. In the past, two or more small openings in the skin (portals) were required in order to allow the passage of both an arthroscope to provide visualization of the knee joint and the instrument used to complete the surgical repair process. However, recent innovations in arthroscopy instrumentation have resulted in the ability to use one portal for knee arthroscopy procedures with both the arthroscope and the instruments passed into the knee joint through the same portal. Both uniportal and two portal arthroscopic techniques are used currently for knee arthroscopy procedures in the Department of Orthopaedic Surgery at Wake Forest Baptist Health. Objectives This randomized, controlled clinical trial will compare the outcomes of single portal versus two portal techniques in patients who have meniscus or articular cartilage pathology. The study hypothesis is that patients who undergo single portal arthroscopy will have less pain post-operatively, use less pain medication, and have a higher International Knee Documentation Committee (IKDC) score at six months and one year compared to patients who undergo traditional two portal knee arthroscopy. Methods and Measures Design: A randomized, controlled trial Setting: Academic Medical Center: single study site at Wake Forest Baptist Health

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Injuries, Knee

Interventions

Single Portal Knee ArthroscopyPROCEDURE

Patients in Group 1 will undergo knee arthroscopy using a single portal.

Two Portal Knee ArthroscopyPROCEDURE

Patients in Group 2 will undergo knee arthroscopy using two portals.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women between 21 and 65 years of age, who agree to comply with the protocol * Patients undergoing a primary knee arthroscopy procedure for meniscus or articular cartilage pathology Exclusion Criteria: * Patients with a history of long term pain medication use and/or chronic pain conditions unrelated to the surgery. * Subjects with severe renal disease, allergies to pain medication, and subjects that will have adverse drug-drug reactions from prescribed pain medication. * Patients with previous reconstructive procedures, lateral retinacular release, or microfracture * Active knee infection or sepsis at the time of surgery * Meniscal injuries requiring repair * Ligamentous instability * Advanced degenerative or inflammatory arthritis * Known cancer at the time of surgery * Conditions that might interfere with recovery from knee arthroscopy (i.e. conditions or diseases of the nervous and/or muscular system, vascular disease, uncontrolled diabetes) * Malignant tumor history or treatment of malignant tumor of the knee * Lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture, knee arthrofibrosis) * Pregnant, breast feeding, or planning on becoming pregnant during the time frame of the study, (if a woman of child-bearing age) * Emotional or neurological conditions that affect the subject's ability or willingness to participate in the study including mental illness or drug and/or alcohol abuse * Severely overweight (BMI \>40) at study enrollment or surgery * Currently participating in another research study * Prisoner or impending imprisonment * Workers' Compensation claims

Locations (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States