Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques



Status:Enrolling by invitation
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:21 - 65
Updated:8/11/2018
Start Date:January 2016
End Date:July 3, 2020

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A Randomized Controlled Trial to Compare Single Portal Versus Two Portal Knee Arthroscopy Techniques in Patients With Meniscal Injuries and Articular Cartilage Pathology

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

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
We found this trial at
1
site
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
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