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Retrospective CT Imaging of BioComposite Interference Screw With BTB

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ClinicalTrials.gov Identifier: NCT02450292
Recruitment Status : Unknown
Verified May 2015 by Marc Fineberg, State University of New York at Buffalo.
Recruitment status was:  Not yet recruiting
First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Marc Fineberg, State University of New York at Buffalo

Brief Summary:
The purpose of this study is to examine the long-term appearance and resorption rate of biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).

Condition or disease Intervention/treatment
ACL Tear Procedure: Bioabsorbable screw fixation

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Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Retrospective CT Imaging of BioComposite Interference Screw in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Graft
Study Start Date : September 2015
Estimated Primary Completion Date : March 2016



Primary Outcome Measures :
  1. Screw resorption [ Time Frame: 5 years ]
    Evaluated on X-ray and CT



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults aged 18+ who had an anterior cruciate ligament (ACL) reconstruction about 5 years ago performed by one of the study investigators.
Criteria

Inclusion Criteria:

  • Ages 18-50
  • Patients who underwent primary ACL reconstruction performed by one of the study investigators at least 5 years ago
  • Isolated ACL tear
  • Type of graft used was bone-patellar tendon-bone autograft
  • Type of screw used to attach graft to the tibia and/or femur was a BioComposite interference screws (Arthrex, Inc.)
  • No degenerative joint disease on preoperative X-rays (> 50% joint space loss, presence of osteophytes)

Exclusion Criteria:

  • Revision ACL reconstructions
  • Types of grafts other than bone-patellar tendon-bone autograft were used
  • ACL tear with concomitant pathology
  • Degenerative joint disease on preoperative X-ray (> 50% joint space loss, presence of osteophytes)
  • Metal or other types of bioabsorbable screws other than BioComposite interference screws (Arthrex, Inc.) were used
  • ACL reconstruction performed less than 5 years ago
  • Pregnancy
  • Greater than Grade 2 laxity of other ligaments
  • No additional fixation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450292


Contacts
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Contact: Melissa Kluczynski, MS 7162043209

Sponsors and Collaborators
State University of New York at Buffalo
Investigators
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Principal Investigator: Marc Fineberg, MD University at Buffalo
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Responsible Party: Marc Fineberg, Chief of Sports Medicine, Associate Professor of Clinical Orthopaedics, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT02450292    
Other Study ID Numbers: 758594-1
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries