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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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 .

Detailed Description

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Conditions

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Primary ACL Tears

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Joseph Lowe, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Other Identifiers

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ACL001-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id