An observational study in Anterior Cruciate Ligament Rupture, sponsored by RTI Surgical. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by RTI Surgical · Observational
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.
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.
558 studies on the registry are indexed under Rupture; 98 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 203 observational studies indexed under Rupture.
Browse Rupture studies →RTI Surgical is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who have had reconstruction of the anterior cruciate ligament and have received a BioCleanse Tibialis allograft for ACL reconstruction.
Exclusion Criteria:
Tibialis Tendon allograft from donor 18-65 years old
Other: BioCleanse Tibialis tendon
Outcomes of anterior cruciate replacement will be evaluated
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.
Time frame: pre-op, 2 months, 4 months, 6 months, 12 months, 24 months
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
Time frame: pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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