Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

Vanderbilt University Medical Center67 enrolled

Overview

To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL reconstruction.

This study will combine the use of survey response, MRI, and x-rays of the knees in Dr. Spindler's ACL reconstructed patients in order to examine long term healing of two types of bioabsorbable screw. We will use a 2-4 yr time point to look at patient reported symptoms of pain and swelling from the surveys and use the x-rays and MRIs to look at absorption of the screw, healing of the graft, and body reactions to the screw.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rupture of Anterior Cruciate Ligament

Eligibility

Sex: ALLMin age: 12 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age range: 12-35 years of age at the time of follow-up. * Gender: Both. * Minorities: All. * Involved in sports at the time of injury. * Participants must be at least two years past the date of ACL reconstruction surgery and not more than four years past the date of surgery * Bioabsorbable Screws used during ACL reconstruction surgery Exclusion Criteria: * Age: \<12 or \>35 years of age * Non-active or unable to participate for health reasons * Simultaneous bilateral ACL reconstruction surgeries. * If any of the following conditions exist in the ipsilateral knee: * Revision ACL reconstruction * Complex knee injury * If any of the following conditions exist in the contralateral knee: * ACL deficient * Prior ACL reconstruction * Prior surgery of any type * Insufficient initial documentation * Cannot be contacted by phone * Neither Calaxo nor Milagro screw used at the time of ACL reconstruction

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Screw integrity

Time frame: 2-4 yrs

Tunnel enlargement

Time frame: 2-4 years

Data from ClinicalTrials.gov

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