Clinical trial NCT02648971: Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Injuries, Knee
Keywords: knee
arthroscopy
portal
meniscus
cartilage injury
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: IKDC (International Knee Documentation Committee) Score
timeFrame: Baseline
measure: IKDC Score
timeFrame: 30 days
measure: IKDC Score
timeFrame: 3 Months
measure: IKDC Score
timeFrame: 6 Months
measure: IKDC Score
timeFrame: 12 Months
Secondary outcomes:
measure: Pain Levels
timeFrame: Days 1 and 4
measure: Number of Participants That Required the Use of Pain Medication
timeFrame: Days 1 and 4
measure: Number of Participants That Required the Use of Narcotics
timeFrame: Days 1 and 4
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Beth P. Smith, PhD
role: STUDY_DIRECTOR
affiliation: Wake Forest University Health Sciences
name: John Hubbard
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1177/03635465010290051301.
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.
citation: 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.
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. doi: 10.1016/j.arthro.2007.02.005.