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NCT02450292 Clinical Trial

Retrospective CT Imaging of BioComposite Interference Screw With BTB

ACL Tear Clinical Trial

Official title:
Retrospective CT Imaging of BioComposite Interference Screw in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Graft

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02450292
Other study ID # 758594-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date July 2016

Study information
Verified date November 2022
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date July 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • ACL Tear
  • Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• Bioabsorbable screw fixation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
State University of New York at Buffalo

Outcome
Type Measure Description Time frame Safety issue
Primary Screw resorption Evaluated on X-ray and CT 5 years
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