Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques

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.

Study Overview

• Status: Terminated
• Conditions: Injuries, Knee
• Intervention / Treatment: Procedure: Single Portal Knee Arthroscopy; Procedure: 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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Single Portal Knee Arthroscopy; Patients in Group 1 will undergo knee arthroscopy using a single portal.
Active Comparator: 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.	Procedure: Two Portal Knee Arthroscopy; Patients in Group 2 will undergo knee arthroscopy using two portals.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Study Director: Beth P. Smith, PhD, Wake Forest University Health Sciences; Principal Investigator: John Hubbard, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, Richmond JC, Shelborne KD. Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med. 2001 Sep-Oct;29(5):600-13. doi: 10.1177/03635465010290051301.
• van de Graaf VA, Wolterbeek N, Scholtes VA, Mutsaerts EL, Poolman RW. Reliability and Validity of the IKDC, KOOS, and WOMAC for Patients With Meniscal Injuries. Am J Sports Med. 2014 Jun;42(6):1408-16. doi: 10.1177/0363546514524698. Epub 2014 Mar 11.
• Cooper DE, Fouts B. Single-portal arthroscopy: report of a new technique. Arthrosc Tech. 2013 Jul 19;2(3):e265-9. doi: 10.1016/j.eats.2013.02.017. eCollection 2013.
• Crawford K, Briggs KK, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the IKDC score for meniscus injuries of the knee. Arthroscopy. 2007 Aug;23(8):839-44. doi: 10.1016/j.arthro.2007.02.005.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: knee; arthroscopy; portal; meniscus; cartilage injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: IRB00030774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No