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Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques

Primary Purpose

Injuries, Knee

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single Portal Knee Arthroscopy
Two Portal Knee Arthroscopy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injuries, Knee focused on measuring knee, arthroscopy, portal, meniscus, cartilage injury

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single Portal Knee Arthroscopy

Two Portal Knee Arthroscopy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).

Secondary Outcome Measures

Pain Levels
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
Number of Participants That Required the Use of Narcotics

Full Information

First Posted
December 15, 2015
Last Updated
December 4, 2020
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02648971
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Study Start Date
January 2016 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Knee
Keywords
knee, arthroscopy, portal, meniscus, cartilage injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Portal Knee Arthroscopy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Two Portal Knee Arthroscopy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Single Portal Knee Arthroscopy
Intervention Description
Patients in Group 1 will undergo knee arthroscopy using a single portal.
Intervention Type
Procedure
Intervention Name(s)
Two Portal Knee Arthroscopy
Intervention Description
Patients in Group 2 will undergo knee arthroscopy using two portals.
Primary Outcome Measure Information:
Title
IKDC (International Knee Documentation Committee) Score
Description
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).
Time Frame
Baseline
Title
IKDC Score
Description
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).
Time Frame
30 days
Title
IKDC Score
Description
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).
Time Frame
3 Months
Title
IKDC Score
Description
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).
Time Frame
6 Months
Title
IKDC Score
Description
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).
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Pain Levels
Description
Pain levels will also be collected at the 1 and 4 day telephone calls. Range 0 - 10, higher scores denotes worse outcomes
Time Frame
Days 1 and 4
Title
Number of Participants That Required the Use of Pain Medication
Time Frame
Days 1 and 4
Title
Number of Participants That Required the Use of Narcotics
Time Frame
Days 1 and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth P. Smith, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Hubbard
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11573919
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.
Results Reference
background
PubMed Identifier
24618098
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.
Results Reference
background
PubMed Identifier
24265996
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.
Results Reference
background
PubMed Identifier
17681205
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.
Results Reference
background

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Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques

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