Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

Completed

• Conditions: Rupture of Anterior Cruciate Ligament

• Registration Number: NCT01069588
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2011-06
• Study Completion: 2012-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tunnel enlargement	2-4 years
Screw integrity	2-4 yrs

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States