Prospective Evaluation of Osseous Integration in ACL Reconstruction Comparing Tightrope vs Interference Screw Fixation

Completed · Not applicable

Conditions studied: ACL - Anterior Cruciate Ligament Rupture

In brief

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. The primary outcome was bone block incorporation within the femoral tunnel at six months. Our null hypothesis was that there is no difference in osseous incorporation or outcome with either type of femoral fixation in primary ACL reconstruction with Achilles tendon allograft. Our secondary outcomes were pain and clinical outcome scores between the two groups.

Key facts

Study ID

NCT03841500

Run by

Kelsey-Seybold Clinic

People needed

37

Starts

2016-01-01

Expected to finish

2017-01-01

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Kelsey-Seybold Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

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