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Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

This study has been completed.
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Kurt P. Spindler, Vanderbilt University Identifier:
First received: February 15, 2010
Last updated: June 6, 2014
Last verified: June 2014
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.

Rupture of Anterior Cruciate Ligament

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up

Resource links provided by NLM:

Further study details as provided by Kurt P. Spindler, Vanderbilt University:

Primary Outcome Measures:
  • Screw integrity [ Time Frame: 2-4 yrs ]
  • Tunnel enlargement [ Time Frame: 2-4 years ]

Enrollment: 67
Study Start Date: December 2009
Study Completion Date: April 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Received Calaxo screw
Received a Milagro screw

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.

Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 2-4 years post ACL reconstruction performed by Dr. Kurt Spindler, under age 35, injured in sport, unilateral primary ACL.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01069588

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-8774
Sponsors and Collaborators
Vanderbilt University
Smith & Nephew, Inc.
Principal Investigator: Kurt P Spindler, M.D. Vanderbilt University
  More Information

Responsible Party: Kurt P. Spindler, Professor, Vanderbilt University Identifier: NCT01069588     History of Changes
Other Study ID Numbers: 090805
Study First Received: February 15, 2010
Last Updated: June 6, 2014

Keywords provided by Kurt P. Spindler, Vanderbilt University:
bioabsorbable screw
acl reconstruction

Additional relevant MeSH terms:
Wounds and Injuries processed this record on August 17, 2017