Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques
NCT ID: NCT02648971
Last Updated: 2020-12-30
Study Results
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View full resultsBasic Information
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TERMINATED
NA
36 participants
INTERVENTIONAL
2016-01-31
2018-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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. 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
Patients in Group 2 will undergo knee arthroscopy using two portals.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing a primary knee arthroscopy procedure for meniscus or articular cartilage pathology
Exclusion Criteria
* 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
21 Years
65 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Beth P. Smith, PhD
Role: STUDY_DIRECTOR
Wake Forest University Health Sciences
John Hubbard
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Countries
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00030774
Identifier Type: -
Identifier Source: org_study_id