NCT01148784

Brief Summary

The purpose of this study is to compare two different soft tissue allografts, double bundle tibialis anterior allograft or quadruple bundle hamstring allograft, used in repairing a torn anterior cruciate ligament (ACL) of the knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

June 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2014

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

2.3 years

First QC Date

June 21, 2010

Last Update Submit

July 9, 2019

Conditions

Anterior Cruciate LigamentInjury

Keywords

anterior cruciate ligament tearACLligamentkneeallograft

Outcome Measures

Primary Outcomes (1)

  • Knee outcome scores

    The change of physical function and pain as evaluated by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score).

    One year

Study Arms (2)

Quadrupled Hamstring Allograft

ACTIVE COMPARATOR
Procedure: ACL reconstruction

Doubled Tibialis Anterior Allograft

ACTIVE COMPARATOR
Procedure: ACL reconstruction

Interventions

ACL reconstructionPROCEDURE

Randomized comparison of two different allogenic tissue types, quadrupled hamstring or doubled tibialis anterior, for anterior cruciate ligament repair.

Doubled Tibialis Anterior AllograftQuadrupled Hamstring Allograft

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ACL injury is the primary limitation to activities of daily living.

You may not qualify if:

  • Multiple current ligamentous injuries to the knee.
  • Revision reconstruction of the ACL.
  • Uncorrected instability of the ACL on the opposite knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesAnterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg Injuries

Study Officials

  • Dennis C Crawford, MD, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

September 17, 2012

Study Completion

April 5, 2014

Last Updated

July 11, 2019

Record last verified: 2019-07

Locations

US(1)