Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Injuries, Knee

Intervention / Treatment
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* Procedure: Single Portal Knee Arthroscopy
* Procedure: Two Portal Knee Arthroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Portal Knee Arthroscopy<br>After randomization for each patient is complete, the website will document the name of the person who logged on to perform the randomization, the date and time of the log in, and the surgical group assignment for each patient. This randomization information will be forwarded to the operating room staff so that they can prepare for each study participant's surgical procedure. Patients in Group 1 will undergo knee arthroscopy using a single portal. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits. | Procedure: Single Portal Knee Arthroscopy<br>* Patients in Group 1 will undergo knee arthroscopy using a single portal.<br>|
| Active Comparator: Two Portal Knee Arthroscopy<br>Patients in Group 2 will undergo knee arthroscopy using two portals. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits. | Procedure: Two Portal Knee Arthroscopy<br>* Patients in Group 2 will undergo knee arthroscopy using two portals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC (International Knee Documentation Committee) Score | IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | Baseline | 
| IKDC Score | IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 30 days | 
| IKDC Score | IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 3 Months | 
| IKDC Score | IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 6 Months | 
| IKDC Score | IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Levels | Pain levels will also be collected at the 1 and 4 day telephone calls. Range 0 - 10, higher scores denotes worse outcomes | Days 1 and 4 | 
| Number of Participants That Required the Use of Pain Medication |  | Days 1 and 4 | 
| Number of Participants That Required the Use of Narcotics |  | Days 1 and 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, arthroscopy, portal, meniscus, cartilage injury