Trial Outcomes & Findings for Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques (NCT NCT02648971)
NCT ID: NCT02648971
Last Updated: 2020-12-30
Results Overview
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).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline
Results posted on
2020-12-30
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Single Portal Knee Arthroscopy
n=18 Participants
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
n=18 Participants
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.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Activity Level
Sporting
|
9 Participants
n=18 Participants
|
12 Participants
n=18 Participants
|
21 Participants
n=36 Participants
|
|
Age, Customized
0-20 Years old
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Age, Customized
21-65 Years old
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
36 Participants
n=36 Participants
|
|
Age, Customized
66 and older
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
17 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=18 Participants
|
11 Participants
n=18 Participants
|
19 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
2 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
7 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=18 Participants
|
13 Participants
n=18 Participants
|
29 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
18 participants
n=18 Participants
|
36 participants
n=36 Participants
|
|
Education
Less than College Grad
|
12 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
20 Participants
n=36 Participants
|
|
Education
College Grad
|
6 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
16 Participants
n=36 Participants
|
|
Activity Level
Non-Sporting
|
9 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
15 Participants
n=36 Participants
|
|
Body Mass Index
|
30.4 kg/m^2
STANDARD_DEVIATION 6.1 • n=18 Participants
|
32.9 kg/m^2
STANDARD_DEVIATION 5.0 • n=18 Participants
|
31.6 kg/m^2
STANDARD_DEVIATION 5.6 • n=36 Participants
|
|
obese
Not Obese
|
8 Participants
n=17 Participants • 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.
|
6 Participants
n=16 Participants • 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.
|
14 Participants
n=33 Participants • 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.
|
|
obese
Obese
|
9 Participants
n=17 Participants • 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.
|
10 Participants
n=16 Participants • 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.
|
19 Participants
n=33 Participants • 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.
|
|
Smoking Status
Yes
|
2 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
4 Participants
n=36 Participants
|
|
Smoking Status
No
|
9 Participants
n=18 Participants
|
11 Participants
n=18 Participants
|
20 Participants
n=36 Participants
|
|
Smoking Status
Quit
|
7 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
12 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: BaselineIKDC 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).
Outcome measures
| Measure |
Single Portal Knee Arthroscopy
n=18 Participants
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
n=18 Participants
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.
|
|---|---|---|
|
IKDC (International Knee Documentation Committee) Score
|
36.6 units on a scale
Standard Deviation 13.3
|
40.2 units on a scale
Standard Deviation 11.1
|
PRIMARY outcome
Timeframe: 30 daysIKDC 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).
Outcome measures
| Measure |
Single Portal Knee Arthroscopy
n=18 Participants
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
n=18 Participants
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.
|
|---|---|---|
|
IKDC Score
|
55.7 units on a scale
Standard Deviation 21.6
|
57.5 units on a scale
Standard Deviation 19.6
|
PRIMARY outcome
Timeframe: 3 MonthsIKDC 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).
Outcome measures
| Measure |
Single Portal Knee Arthroscopy
n=18 Participants
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
n=18 Participants
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.
|
|---|---|---|
|
IKDC Score
|
63.1 units on a scale
Standard Deviation 25.6
|
66.7 units on a scale
Standard Deviation 24.0
|
PRIMARY outcome
Timeframe: 6 MonthsIKDC 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).
Outcome measures
| Measure |
Single Portal Knee Arthroscopy
n=18 Participants
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
n=18 Participants
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.
|
|---|---|---|
|
IKDC Score
|
61.5 units on a scale
Standard Deviation 23.4
|
67.4 units on a scale
Standard Deviation 19.7
|
PRIMARY outcome
Timeframe: 12 MonthsIKDC 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).
Outcome measures
| Measure |
Single Portal Knee Arthroscopy
n=18 Participants
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
n=18 Participants
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.
|
|---|---|---|
|
IKDC Score
|
64.1 units on a scale
Standard Deviation 25.6
|
72.6 units on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: Days 1 and 4Pain levels will also be collected at the 1 and 4 day telephone calls. Range 0 - 10, higher scores denotes worse outcomes
Outcome measures
| Measure |
Single Portal Knee Arthroscopy
n=18 Participants
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
n=18 Participants
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.
|
|---|---|---|
|
Pain Levels
Day 1
|
3.6 units on a scale
Standard Deviation 2.2
|
3.9 units on a scale
Standard Deviation 2.7
|
|
Pain Levels
Day 4
|
2.0 units on a scale
Standard Deviation 1.6
|
2.5 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Days 1 and 4Outcome measures
| Measure |
Single Portal Knee Arthroscopy
n=18 Participants
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
n=18 Participants
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.
|
|---|---|---|
|
Number of Participants That Required the Use of Pain Medication
Day 1
|
15 Participants
|
13 Participants
|
|
Number of Participants That Required the Use of Pain Medication
Day 4
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Days 1 and 4Outcome measures
| Measure |
Single Portal Knee Arthroscopy
n=18 Participants
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
n=18 Participants
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.
|
|---|---|---|
|
Number of Participants That Required the Use of Narcotics
Day 1
|
13 Participants
|
11 Participants
|
|
Number of Participants That Required the Use of Narcotics
Day 4
|
7 Participants
|
4 Participants
|
Adverse Events
Single Portal Knee Arthroscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Two Portal Knee Arthroscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place