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Completed

NCT Number: NCT01069588

Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

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.

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Key information

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8774, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Screw integrity

    Time frame: 2-4 yrs

  2. Tunnel enlargement

    Time frame: 2-4 years

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Smith & Nephew, Inc.

Registry information

Official study title

ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Feb 17, 2010
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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