Retrospective CT Imaging of BioComposite Interference Screw With BTB

November 11, 2022 updated by: Marc Fineberg, State University of New York at Buffalo

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screw resorption
Time Frame: 5 years
Evaluated on X-ray and CT
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Investigators

  • Principal Investigator: Marc Fineberg, MD, University at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (ESTIMATE)

May 21, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 758594-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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