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The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACL reconstruction control | Active Comparator | The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts. |
|
| ACL Biocleanse, surgical | Experimental | The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL reconstruction control | Procedure | The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 month period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter A. Indelicato, M.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Orthopedics and Sports Medicine Institute | Gainesville | Florida | 32611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | ACL Biocleanse, Surgical |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Mean | 95% Confidence Interval | score | 24 month period |
|
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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 | 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 asceptic patellar tendon allografts. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Indelicato, MD | University of Florida | 352-273-7017 | wernegs@ortho.ufl.edu |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| ACL Biocleanse, surgical | Procedure | The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process. |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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.
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 43 | 0 | 43 |
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