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
• Status: Completed
• 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
• 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

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