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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Portal Knee Arthroscopy | Active Comparator | 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. |
|
| Two Portal Knee Arthroscopy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Portal Knee Arthroscopy | Procedure | Patients in Group 1 will undergo knee arthroscopy using a single portal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants That Required the Use of Pain Medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth P. Smith, PhD | Wake Forest University Health Sciences | Study Director |
| John Hubbard | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11573919 | Background | 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. | |
| 24618098 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Hubbard | Wake Forest University | 336-998-1297 | jhubbard@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 14, 2018 | Oct 16, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2018 | Nov 9, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Two Portal Knee Arthroscopy | Procedure | Patients in Group 2 will undergo knee arthroscopy using two portals. |
|
| Days 1 and 4 |
| Number of Participants That Required the Use of Narcotics | Days 1 and 4 |
| 24265996 | Background | 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. |
| 17681205 | Background | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Activity Level | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| obese | One subject from the Single Portal Knee Arthroscopy arm and two subjects from the Two Portal Knee Arthroscopy arm did not provide obesity information, which explains the discrepancy in the overall number of participants analyzed for this measure. | Count of Participants | Participants |
|
| Smoking Status | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | 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 | Posted | Mean | Standard Deviation | units on a scale | Days 1 and 4 |
|
|
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| Secondary | Number of Participants That Required the Use of Pain Medication | Posted | Count of Participants | Participants | Days 1 and 4 |
|
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| Secondary | Number of Participants That Required the Use of Narcotics | Posted | Count of Participants | Participants | Days 1 and 4 |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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