BioCleanse Tibialis Tendon Anterior Cruciate Ligament (AC... | NCT00975845

Studies
BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study

NCT00975845

Sponsor

RTI Surgical

Status

Completed

Last Update Posted

Nov 1, 2021Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Anterior Cruciate Ligament Rupture

Interventions

BioCleanse Tibialis tendon

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 9, 2017Actual

Primary Completion Date

Nov 9, 2017Actual

Completion Date

Nov 9, 2017Actual

First Submitted Date

Sep 10, 2009

First Submission Date that Met QC Criteria

Sep 10, 2009

First Posted Date

Sep 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2021

Last Update Posted Date

Nov 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BioCleanse Tibialis Tendon Allograft		Tibialis Tendon allograft from donor 18-65 years old	Other: BioCleanse Tibialis tendon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BioCleanse Tibialis tendon	Other	Outcomes of anterior cruciate replacement will be evaluated	BioCleanse Tibialis Tendon Allograft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients who have had reconstruction of the anterior cruciate ligament and have received a BioCleanse Tibialis allograft for ACL reconstruction.

Sampling Method

Non-Probability Sample

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries