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ClinicalTrials.gov Identifier: NCT01069588
Recruitment Status :
First Posted : February 17, 2010
Last Update Posted : November 30, 2017
Vanderbilt University Medical Center
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Kurt P. Spindler, Vanderbilt University Medical Center
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 or disease
Rupture of Anterior Cruciate Ligament
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.
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Ages Eligible for Study:
12 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients 2-4 years post ACL reconstruction performed by Dr. Kurt Spindler, under age 35, injured in sport, unilateral primary ACL.
Age range: 12-35 years of age at the time of follow-up.
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
Age: <12 or >35 years of age
Non-active or unable to participate for health reasons