Injuries, Knee
Conditions
Keywords
knee, arthroscopy, portal, meniscus, cartilage injury
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
Interventions
PROCEDURESingle Portal Knee Arthroscopy
Patients in Group 1 will undergo knee arthroscopy using a single portal.
PROCEDURETwo Portal Knee Arthroscopy
Patients in Group 2 will undergo knee arthroscopy using two portals.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IKDC Score | 30 days | 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 (International Knee Documentation Committee) Score | Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Levels | Days 1 and 4 | 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 | Days 1 and 4 | — |
| Number of Participants That Required the Use of Narcotics | Days 1 and 4 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Single Portal Knee Arthroscopy | Two Portal Knee Arthroscopy | Total |
|---|---|---|---|
| Activity Level Non-Sporting | 9 Participants | 6 Participants | 15 Participants |
| Activity Level Sporting | 9 Participants | 12 Participants | 21 Participants |
| Age, Customized 0-20 Years old | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 21-65 Years old | 18 Participants | 18 Participants | 36 Participants |
| Age, Customized 66 and older | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index | 30.4 kg/m^2 STANDARD_DEVIATION 6.1 | 32.9 kg/m^2 STANDARD_DEVIATION 5 | 31.6 kg/m^2 STANDARD_DEVIATION 5.6 |
| Education College Grad | 6 Participants | 10 Participants | 16 Participants |
| Education Less than College Grad | 12 Participants | 8 Participants | 20 Participants |
| obese Not Obese | 8 Participants | 6 Participants | 14 Participants |
| obese Obese | 9 Participants | 10 Participants | 19 Participants |
| Race/Ethnicity, Customized Non-White | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 13 Participants | 29 Participants |
| Region of Enrollment United States | 18 participants | 18 participants | 36 participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
| Smoking Status No | 9 Participants | 11 Participants | 20 Participants |
| Smoking Status Quit | 7 Participants | 5 Participants | 12 Participants |
| Smoking Status Yes | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Portal Knee Arthroscopy | IKDC (International Knee Documentation Committee) Score | 36.6 units on a scale | Standard Deviation 13.3 |
| Two Portal Knee Arthroscopy | IKDC (International Knee Documentation Committee) Score | 40.2 units on a scale | Standard Deviation 11.1 |
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).
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Portal Knee Arthroscopy | IKDC Score | 55.7 units on a scale | Standard Deviation 21.6 |
| Two Portal Knee Arthroscopy | IKDC Score | 57.5 units on a scale | Standard Deviation 19.6 |
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).
Time frame: 3 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Portal Knee Arthroscopy | IKDC Score | 63.1 units on a scale | Standard Deviation 25.6 |
| Two Portal Knee Arthroscopy | IKDC Score | 66.7 units on a scale | Standard Deviation 24 |
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).
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Portal Knee Arthroscopy | IKDC Score | 61.5 units on a scale | Standard Deviation 23.4 |
| Two Portal Knee Arthroscopy | IKDC Score | 67.4 units on a scale | Standard Deviation 19.7 |
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).
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Portal Knee Arthroscopy | IKDC Score | 64.1 units on a scale | Standard Deviation 25.6 |
| Two Portal Knee Arthroscopy | IKDC Score | 72.6 units on a scale | Standard Deviation 12.7 |
Secondary
Number of Participants That Required the Use of Narcotics
Time frame: Days 1 and 4
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Portal Knee Arthroscopy | Number of Participants That Required the Use of Narcotics | Day 1 | 13 Participants |
| Single Portal Knee Arthroscopy | Number of Participants That Required the Use of Narcotics | Day 4 | 7 Participants |
| Two Portal Knee Arthroscopy | Number of Participants That Required the Use of Narcotics | Day 1 | 11 Participants |
| Two Portal Knee Arthroscopy | Number of Participants That Required the Use of Narcotics | Day 4 | 4 Participants |
Secondary
Number of Participants That Required the Use of Pain Medication
Time frame: Days 1 and 4
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Portal Knee Arthroscopy | Number of Participants That Required the Use of Pain Medication | Day 1 | 15 Participants |
| Single Portal Knee Arthroscopy | Number of Participants That Required the Use of Pain Medication | Day 4 | 10 Participants |
| Two Portal Knee Arthroscopy | Number of Participants That Required the Use of Pain Medication | Day 1 | 13 Participants |
| Two Portal Knee Arthroscopy | Number of Participants That Required the Use of Pain Medication | Day 4 | 6 Participants |
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
Time frame: Days 1 and 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Portal Knee Arthroscopy | Pain Levels | Day 1 | 3.6 units on a scale | Standard Deviation 2.2 |
| Single Portal Knee Arthroscopy | Pain Levels | Day 4 | 2.0 units on a scale | Standard Deviation 1.6 |
| Two Portal Knee Arthroscopy | Pain Levels | Day 1 | 3.9 units on a scale | Standard Deviation 2.7 |
| Two Portal Knee Arthroscopy | Pain Levels | Day 4 | 2.5 units on a scale | Standard Deviation 2.3 |