BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

A Prospective, Double-Blind Evaluation of the Effects of BioCleanse Tibialis Tendon Allograft and Donor Age on Clinical Outcomes of ACL Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975845
• Other study ID #: BCTib 2008
• Status: Completed
• Start date: November 9, 2017
• Est. completion date: November 9, 2017

Study information

• Verified date: October 2021
• Source: RTI Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 9, 2017
• Est. primary completion date: November 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Other:
• BioCleanse Tibialis tendon
Outcomes of anterior cruciate replacement will be evaluated

Locations

Country	Name	City	State
United States	The Orthopedic Clinic, Assoc	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
RTI Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre-op, 2 months, 4 months, 6 months, 12 months, 24 months
Secondary	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	pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months