Investigation of Clinical Outcome of ACL Reconstruction Utilizing Two Tibial Fixation Techniques, Concentric Tapered Interference Screws and Interference Screw and Sheath

This study has been withdrawn prior to recruitment.

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00364897

Purpose

Tibial fixation is the weak link when using soft tissue grafts and interference screws for fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of patients undergoing double loop hamstring autograft ACL reconstruction and compare between the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .

Condition	Phase
Primary ACL Tears	Phase II

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	Comparison Between Two Tibial Fixation Techniques in ACL Reconstruction

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment:

140

Eligibility

Ages Eligible for Study:	21 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females between ages 21 and 40 years.
Primary ACL tears.
Signed Informed consent.
Availability during follow up period.

Exclusion Criteria:

Additional meniscal injury requiring suture.
Articular cartilage injury requiring surgical management.
Concomitant ligament injuries to the same knee requiring surgery.
Bilateral ACL injury.
Revision ACL surgery.
Concurrent fractures of the lower limbs caused by the same accident.
Post operative wound infection.

• Post operative nerve injury
Cardiovascular compromise.
Professional sports people.
Soldiers on active military service.
Patients actively seeking compensation for injury.
Patients on other research protocols.
Patients receiving medications which alter bone metabolism: corticosteriods, Calcitonin, Flourides, Biphosphonates, Vitamin D and its derivatives, Cytotoxic drugs.
Non compliance. • Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364897

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Joseph Lowe, Dr.

Hadassah Medical Organization

More Information

Study ID Numbers:	ACL001-HMO-CTIL
Study First Received:	August 15, 2006
Last Updated:	April 10, 2007
ClinicalTrials.gov Identifier:	NCT00364897
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Lacerations

ClinicalTrials.gov processed this record on January 14, 2009