Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques

Injuries, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02648971
• Other study ID #: IRB00030774
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: November 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Injuries, Knee
• Knee Injuries

Intervention

Procedure:
• Single Portal Knee Arthroscopy
Patients in Group 1 will undergo knee arthroscopy using a single portal.
• Two Portal Knee Arthroscopy
Patients in Group 2 will undergo knee arthroscopy using two portals.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Number of Participants That Required the Use of Pain Medication		Days 1 and 4
Secondary	Number of Participants That Required the Use of Narcotics		Days 1 and 4