Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques

Not Applicable

Terminated

• Conditions: Injuries, Knee
• Interventions: Procedure: Single Portal Knee Arthroscopy; Procedure: Two Portal Knee Arthroscopy

• Registration Number: NCT02648971
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-12-15
• Study Start: 2016-01
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Results First Submitted: 2020-10-16
• Status Verified: 2020-11
• Results First Submitted QC: 2020-12-04
• Last Update Submitted: 2020-12-04
• Results First Posted: 2020-12-30
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Portal Knee Arthroscopy	Single Portal Knee Arthroscopy	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.
Two Portal Knee Arthroscopy	Two Portal Knee Arthroscopy	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.

Primary Outcome Measures

Name	Time	Method
IKDC Score	12 Months	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).
IKDC (International Knee Documentation Committee) Score	Baseline	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States