NCT00975845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
8.2 years until next milestone

Study Start

First participant enrolled

November 9, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2017

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

Same day

First QC Date

September 10, 2009

Last Update Submit

October 28, 2021

Conditions

Anterior Cruciate Ligament Rupture

Keywords

ACLAnterior Cruciate LigamentTorn tendonACL RepairACL reconstruction

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Subjective quality of life scores

    pre-op, 2 months, 4 months, 6 months, 12 months, and 24 months

Study Arms (1)

BioCleanse Tibialis Tendon Allograft

Tibialis Tendon allograft from donor 18-65 years old

Other: BioCleanse Tibialis tendon

Interventions

BioCleanse Tibialis tendonOTHER

Outcomes of anterior cruciate replacement will be evaluated

BioCleanse Tibialis Tendon Allograft

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • No chondral defects
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Orthopedic Clinic, Assoc

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Thomas Carter, MD

    Foundation for Orthopedic Research and Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

November 9, 2017

Primary Completion

November 9, 2017

Study Completion

November 9, 2017

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)