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Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069588
First Posted: February 17, 2010
Last Update Posted: November 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Kurt P. Spindler, Vanderbilt University Medical Center
February 15, 2010
February 17, 2010
November 30, 2017
December 2009
June 2011   (Final data collection date for primary outcome measure)
  • Screw integrity [ Time Frame: 2-4 yrs ]
  • Tunnel enlargement [ Time Frame: 2-4 years ]
  • Screw integrity [ Time Frame: 2-4 yrs ]
  • Tunnel enlargement [ Time Frame: 2-4 years ]
  • Graft integrity [ Time Frame: 2-4 years ]
  • Graft incorporation [ Time Frame: 2-4 yrs ]
  • Foreign body reaction [ Time Frame: 2-4 years ]
  • Patient discomfort related to the screw [ Time Frame: 2-4 years ]
Complete list of historical versions of study NCT01069588 on ClinicalTrials.gov Archive Site
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Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw
ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients 2-4 years post ACL reconstruction performed by Dr. Kurt Spindler, under age 35, injured in sport, unilateral primary ACL.
Rupture of Anterior Cruciate Ligament
Not Provided
  • Calaxo
    Received Calaxo screw
  • Milagro
    Received a Milagro screw
Cox CL, Spindler KP, Leonard JP, Morris BJ, Dunn WR, Reinke EK. Do newer-generation bioabsorbable screws become incorporated into bone at two years after ACL reconstruction with patellar tendon graft?: A cohort study. J Bone Joint Surg Am. 2014 Feb 5;96(3):244-50. doi: 10.2106/JBJS.L.01652.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
April 2012
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 35 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01069588
090805
Yes
Not Provided
Not Provided
Kurt P. Spindler, Vanderbilt University Medical Center
Vanderbilt University Medical Center
Smith & Nephew, Inc.
Principal Investigator: Kurt P Spindler, M.D. Vanderbilt University Medical Center
Vanderbilt University Medical Center
November 2017