Anterior Cruciate Ligament RuptureNCT00975845
BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
An observational study of Anterior Cruciate Ligament Rupture, run by RTI Surgical at 1 site in United States.
Trial summary
To compare the outcome of Anterior Cruciate Ligament (ACL) reconstruction performed using the tibialis allograft to historical outcomes of ACL reconstruction patients and to establish if any correlation exists between the age of the graft donor and the clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- BioCleanse Tibialis tendon
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2017to 9 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who have had reconstruction of the anterior cruciate ligament and have received a BioCleanse Tibialis allograft for ACL reconstruction.
Who may be able to join
- Study subjects will be limited to those subjects undergoing allograft anterior cruciate ligament reconstruction surgery
- Meniscal injuries may be included
- Isolated, unilateral anterior cruciate ligament injury.
- All subjects will have a minimum age of eighteen (18) years and a maximum of sixty (60) years.
- Both male and non-pregnant female subjects will be included.
- To facilitate follow-up, study subjects will be limited to the local geographic area of the study site and be willing to use the rehabilitation facility and physical therapy schedule assigned by the surgeon.
- All subjects must be able to read, write, and comprehend instructions and guidelines in English and understand (and sign as an acknowledgment of their understanding) an informed consent declaration.
Who cannot join
- No chondral defects
- Failure to comply with or meet all of the inclusion criteria listed above.
- Autograft anterior cruciate ligament surgery on either knee.
- Anterior cruciate ligament injury on contra-lateral leg at any time
- Multi-ligament reconstruction
- Inability to comply with all requirements of this investigation, as well as follow the instructions of the physician.
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- Significant systemic disease or conditions which impact overall health or well being or which necessitate chronic medication use.
- Revision anterior cruciate ligament surgery to either knee at anytime
- Exhibiting signs of moderate to severe degenerative joint disease in addition to requiring anterior cruciate ligament surgery.
- Concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Orthopedic Clinic, Assoc
Phoenix, Arizona, 85016
About this study
Official title: A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction
To compare the outcome of Anterior Cruciate Ligament (ACL) reconstruction performed using the tibialis allograft to historical outcomes of ACL reconstruction patients and to establish if any correlation exists between the age of the graft donor and the clinical outcomes.
Read the detailed description
This is a single-arm, single site, pilot study in patients with a ruptured ACL. A total of fifty (50) subjects will be enrolled in this trial. All patients will have been scheduled to undergo ACL reconstruction and will receive a BioCleanse Tibialis allograft as part of the normal standard of care practiced by the treating surgeon. Follow up is for 2 years.
However, there is no assignment of graft, specific to donor age, to the patients. All treatment will follow standard of care and this study assumes that there will be a normal distribution of graft donor ages, from 18 to 65 years of age.
Patient outcomes will be compared between the 2 groups of tendon donor ages. Neither the surgeon nor the patient will be aware of the age of the graft donor, per typical standard of care.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- BioCleanse Tibialis tendon
- Keywords
- ACL, Anterior Cruciate Ligament, Torn tendon, ACL Repair, ACL reconstruction
- 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.
BioCleanse Tibialis tendonOther
Outcomes of anterior cruciate replacement will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| BioCleanse Tibialis Tendon Allograft | Tibialis Tendon allograft from donor 18-65 years old Receives: Other: BioCleanse Tibialis tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective International Knee Documentation Committee (IKDC) Exam
The International Knee Documentation Committee (IKDC) is a knee-specific patient-reported outcome measure. This is an indexed score form 0-100, with 0 being the worst possible status and 100 indicating no dysfunction, disability or pain.
Measured: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months
Secondary outcomes (1)
Subjective quality of life scores
The SF36 measures the quality life as reported by the paritricpantm, and is an indexed score form 0 - 100. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Measured: pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study start9 Nov 2017
- Primary completion9 Nov 2017
- Study completion9 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Carter, MD, Principal investigator, Foundation for Orthopedic Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975845
- Sponsor's protocol ID
- BCTib 2008
- Status last verified
- Oct 2021
- First submitted
- 10 Sep 2009
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction
- ClinicalTrials.gov ID
- NCT00975845
- Acronym / sponsor ID
- BCTib 2008
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- ACL, Anterior Cruciate Ligament, Torn tendon, ACL Repair, ACL reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the outcome of Anterior Cruciate Ligament (ACL) reconstruction performed using the tibialis allograft to historical outcomes of ACL reconstruction patients and to establish if any correlation exists between the age of the graft donor and the clinical outcomes.
Detailed description
This is a single-arm, single site, pilot study in patients with a ruptured ACL. A total of fifty (50) subjects will be enrolled in this trial. All patients will have been scheduled to undergo ACL reconstruction and will receive a BioCleanse Tibialis allograft as part of the normal standard of care practiced by the treating surgeon. Follow up is for 2 years.
However, there is no assignment of graft, specific to donor age, to the patients. All treatment will follow standard of care and this study assumes that there will be a normal distribution of graft donor ages, from 18 to 65 years of age.
Patient outcomes will be compared between the 2 groups of tendon donor ages. Neither the surgeon nor the patient will be aware of the age of the graft donor, per typical standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioCleanse Tibialis Tendon Allograft | – | Other: BioCleanse Tibialis tendonTibialis Tendon allograft from donor 18-65 years old |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who have had reconstruction of the anterior cruciate ligament and have received a BioCleanse Tibialis allograft for ACL reconstruction.
Key inclusion criteria (7 listed)
- Study subjects will be limited to those subjects undergoing allograft anterior cruciate ligament reconstruction surgery
- Meniscal injuries may be included
- Isolated, unilateral anterior cruciate ligament injury.
- All subjects will have a minimum age of eighteen (18) years and a maximum of sixty (60) years.
- Both male and non-pregnant female subjects will be included.
Key exclusion criteria (10 listed)
- No chondral defects
- Failure to comply with or meet all of the inclusion criteria listed above.
- Autograft anterior cruciate ligament surgery on either knee.
- Anterior cruciate ligament injury on contra-lateral leg at any time
- Multi-ligament reconstruction
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 |
|---|---|---|
| BioCleanse Tibialis tendonOutcomes of anterior cruciate replacement will be evaluated | Other | BioCleanse Tibialis Tendon Allograft |
Primary outcome
Objective International Knee Documentation Committee (IKDC) Exam
Time frame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months
The International Knee Documentation Committee (IKDC) is a knee-specific patient-reported outcome measure. This is an indexed score form 0-100, with 0 being the worst possible status and 100 indicating no dysfunction, disability or pain.
1 secondary outcome
Subjective quality of life scores
Time frame: pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Thomas Carter, MD principal investigator
Foundation for Orthopedic Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture, run by RTI Surgical 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 7 inclusion and 10 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 1 Nov 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective International Knee Documentation Committee (IKDC) Exam (time frame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months). 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 1 Nov 2021.