Trial Outcomes & Findings for Evaluation of Biocleanse Allografts For ACL Reconstruction (NCT NCT00187876)
NCT ID: NCT00187876
Last Updated: 2014-03-04
Results Overview
The IKDC Subjective Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0-100. A score of 100 is interpreted to mean no limitation with activities of daily living and the absence of symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
67 participants
Primary outcome timeframe
24 month period
Results posted on
2014-03-04
Participant Flow
Participant milestones
| Measure |
ACL Reconstruction Control
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that are non- irradiated aseptically, processed BTB allografts.
|
ACL Biocleanse, Surgical
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
43
|
|
Overall Study
COMPLETED
|
24
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Biocleanse Allografts For ACL Reconstruction
Baseline characteristics by cohort
| Measure |
ACL Reconstruction Control
n=24 Participants
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts.
|
ACL Biocleanse, Surgical
n=43 Participants
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
43 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 month periodThe IKDC Subjective Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0-100. A score of 100 is interpreted to mean no limitation with activities of daily living and the absence of symptoms.
Outcome measures
| Measure |
ACL Reconstruction Control
n=24 Participants
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts.
|
ACL Biocleanse, Surgical
n=43 Participants
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
|
|---|---|---|
|
International Knee Documentation Committee (IKDC) Form
|
89 score
Interval 81.2 to 96.4
|
88 score
Interval 80.6 to 95.4
|
Adverse Events
ACL Reconstruction Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ACL Biocleanse, Surgical
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