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Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

This study has been completed.
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Kurt P. Spindler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01069588
First received: February 15, 2010
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Screw integrity [ Time Frame: 2-4 yrs ] [ Designated as safety issue: No ]
  • Tunnel enlargement [ Time Frame: 2-4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Study Completion Date: April 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Calaxo
Received Calaxo screw
Milagro
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.

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069588

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

No publications provided

Responsible Party: Kurt P. Spindler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01069588     History of Changes
Other Study ID Numbers: 090805
Study First Received: February 15, 2010
Last Updated: September 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
bioabsorbable screw
acl reconstruction

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013