Trial Outcomes & Findings for In Vivo Arthroscopic Behavior of the Infrapatellar Plica of the Knee (NCT NCT00643487)
NCT ID: NCT00643487
Last Updated: 2018-04-24
Results Overview
Observe the behavior of the IPP of the knee by fluoroscopy. A complete recording was obtained in 2 patients: this implied that the plica,central body, and fat pad were visualized. The patients then completed a series of manouevres which demonstrated the mechanical behavior of the infrapatellar plica-fat pad complex.
Recruitment status
COMPLETED
Target enrollment
8 participants
Primary outcome timeframe
During procedure, on average one hour.
Results posted on
2018-04-24
Participant Flow
Participant milestones
| Measure |
All Participants
In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
All Participants
In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
|
|---|---|
|
Overall Study
Technical difficulty
|
3
|
Baseline Characteristics
In Vivo Arthroscopic Behavior of the Infrapatellar Plica of the Knee
Baseline characteristics by cohort
| Measure |
All Participants
n=8 Participants
No new arms or groups were associated with this observational study
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: During procedure, on average one hour.Observe the behavior of the IPP of the knee by fluoroscopy. A complete recording was obtained in 2 patients: this implied that the plica,central body, and fat pad were visualized. The patients then completed a series of manouevres which demonstrated the mechanical behavior of the infrapatellar plica-fat pad complex.
Outcome measures
| Measure |
All Participants
n=8 Participants
In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
|
|---|---|
|
Number of Participants With Successful Recording.
Complete Recording
|
2 Participants
|
|
Number of Participants With Successful Recording.
Partial Recording
|
3 Participants
|
Adverse Events
All Participants
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