Retrospective CT Imaging of BioComposite Interference Screw With BTB

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).

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Key information

Conditions

ACL Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioabsorbable screw fixation

Procedure

Primary outcomes

Screw resorption

Time frame: 5 years

Evaluated on X-ray and CT

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: May 21, 2015
Registry last updated: Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed