Anterior Cruciate Ligament Tear
Conditions
Brief summary
The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.
Detailed description
The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process. You are being asked to volunteer in a research study. The purpose of this study is to compare the different ways of cleaning allograft tendons used to replace the main ligament in the knee. The anterior cruciate ligament (ACL) is the main ligament in the knee that your doctor will replace in your surgery. The allograft tendons come from other people who have donated a tendon from the front of the knee after they died. The three ways of cleaning the tendons that will be used in this study are BioCleanse, irradiation, and aseptic. Aseptic uses clean conditions when preparing the tissue for surgery, sometimes with a chemical bath. BioCleanse is a way of cleaning the tendon physically and chemically, while irradiation uses gamma rays. The goal is to clean the tendons to make them safer for the patients without weakening the tendon when put in the knee.
Interventions
PROCEDUREACL reconstruction control
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
PROCEDUREACL Biocleanse, surgical
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* ACL reconstruction
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) Form | 24 month period | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 aseptic patellar tendon allografts. | 24 |
| 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. | 43 |
| Total | 67 |
Baseline characteristics
| Characteristic | ACL Reconstruction Control | ACL Biocleanse, Surgical | Total |
|---|---|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 9.2 | 35.6 years STANDARD_DEVIATION 8.9 | 33.5 years STANDARD_DEVIATION 9.05 |
| Region of Enrollment United States | 24 participants | 43 participants | 67 participants |
| Sex: Female, Male Female | 8 Participants | 18 Participants | 26 Participants |
| Sex: Female, Male Male | 16 Participants | 25 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 43 |
| serious Total, serious adverse events | 0 / 24 | 0 / 43 |
Outcome results
Primary
International Knee Documentation Committee (IKDC) Form
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.
Time frame: 24 month period
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACL Reconstruction Control | International Knee Documentation Committee (IKDC) Form | 89 score |
| ACL Biocleanse, Surgical | International Knee Documentation Committee (IKDC) Form | 88 score |