BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

Completed

• Conditions: Anterior Cruciate Ligament Rupture
• Interventions: Other: BioCleanse Tibialis tendon

• Registration Number: NCT00975845
• Lead Sponsor: RTI Surgical

Brief 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.

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 Timeline

• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Study Start: 2017-11-09
• Primary Completion: 2017-11-09
• Study Completion: 2017-11-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Study subjects will be limited to those subjects undergoing allograft anterior cruciate ligament reconstruction surgery
2. Meniscal injuries may be included
3. Isolated, unilateral anterior cruciate ligament injury.
4. All subjects will have a minimum age of eighteen (18) years and a maximum of sixty (60) years.
5. Both male and non-pregnant female subjects will be included.
6. 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.
7. 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.

Exclusion Criteria

1. No chondral defects
2. Failure to comply with or meet all of the inclusion criteria listed above.
3. Autograft anterior cruciate ligament surgery on either knee.
4. Anterior cruciate ligament injury on contra-lateral leg at any time
5. Multi-ligament reconstruction
6. Inability to comply with all requirements of this investigation, as well as follow the instructions of the physician.
7. Significant systemic disease or conditions which impact overall health or well being or which necessitate chronic medication use.
8. Revision anterior cruciate ligament surgery to either knee at anytime
9. Exhibiting signs of moderate to severe degenerative joint disease in addition to requiring anterior cruciate ligament surgery.
10. Concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BioCleanse Tibialis Tendon Allograft	BioCleanse Tibialis tendon	Tibialis Tendon allograft from donor 18-65 years old

Primary Outcome Measures

Name	Time	Method
Objective International Knee Documentation Committee (IKDC) Exam	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.

Secondary Outcome Measures

Name	Time	Method
Subjective quality of life scores	pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months	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

Trial Locations

Locations (1)

The Orthopedic Clinic, Assoc; 🇺🇸 Phoenix, Arizona, United States