Anterior Cruciate Ligament TearPhase 4NCT00187876
Evaluation of Biocleanse Allografts For ACL Reconstruction
A Phase 4 study testing ACL Biocleanse, surgical in people with Anterior Cruciate Ligament Tear, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- ACL Biocleanse, surgical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ACL reconstruction
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Orthopedics and Sports Medicine Institute
Gainesville, Florida, 32611
About this study
Official title: Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation
The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- ACL reconstruction control, ACL Biocleanse, surgical
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstruction controlProcedure or surgery
Also called Standard ACL allograft
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgicalProcedure or surgery
Also called BioCleanse™ process
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
| Study group | Role | What they receive |
|---|---|---|
| ACL reconstruction control | Active comparator | The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts. Receives: Procedure: ACL reconstruction control |
| 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. Receives: Procedure: ACL Biocleanse, surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter A. Indelicato, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187876
- Sponsor's protocol ID
- 566-2003
- Status last verified
- Jan 2014
- First submitted
- 12 Sep 2005
- Last updated
- 4 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation
- ClinicalTrials.gov ID
- NCT00187876
- Acronym / sponsor ID
- 566-2003
- Conditions
- Anterior Cruciate Ligament Tear
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 4 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL reconstruction control | Active comparator | Procedure: ACL reconstruction controlThe intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts. |
| ACL Biocleanse, surgical | Experimental | Procedure: ACL Biocleanse, surgicalThe intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ACL reconstruction
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL reconstruction controlAlso: Standard ACL allograftThe intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process. | Procedure or surgery | ACL reconstruction control |
| ACL Biocleanse, surgicalAlso: BioCleanse™ processThe intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process. | Procedure or surgery | ACL Biocleanse, surgical |
Primary outcome
International Knee Documentation Committee (IKDC) Form
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A. Indelicato, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACL Biocleanse, surgical in people with Anterior Cruciate Ligament Tear, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) Form (time frame: 24 month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.