Status:
COMPLETED
Prospective Evaluation of Osseous Integration in ACL Reconstruction Comparing Tightrope vs Interference Screw Fixation
Lead Sponsor:
Kelsey-Seybold Clinic
Collaborating Sponsors:
Baylor College of Medicine
Conditions:
ACL - Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The purpose of our study was to compare osseous integration of the bone block in Achilles tendon allograft ACL reconstruction using a cortical button versus biocomposite interference screw fixation. T...
Detailed Description
After obtaining institutional review board approval the investigators conducted this prospective randomized controlled trial with goal of 1:1 allocation ratio between the two study groups. All subject...
Eligibility Criteria
Inclusion
- patients between the ages of 18 and 50 able to provide informed consent with ACL tears meeting the indications for reconstruction and electing to undergo reconstruction with an Achilles tendon allograft.
Exclusion
- History of prior ACL reconstruction
- pregnancy
- inflammatory disease
- a primary bone disorder
- those taking bone resorption inhibitor medications
- those with injuries to the collateral ligaments or posterior cruciate ligament
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03841500
Start Date
January 1 2016
End Date
January 1 2017
Last Update
February 15 2019
Active Locations (1)
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1
Kelsey-Seybold Clinic
Houston, Texas, United States, 77030