Retrospective CT Imaging of BioComposite Interference Scr... | NCT02450292

Studies
Retrospective CT Imaging of BioComposite Interference Screw With BTB

NCT02450292

Sponsor

State University of New York at Buffalo

Status

Completed

Last Update Posted

Nov 16, 2022Actual

Enrollment

5Actual

Phase

Not provided

Conditions

ACL Tear

Interventions

Bioabsorbable screw fixation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

May 18, 2015

First Submission Date that Met QC Criteria

May 18, 2015

First Posted Date

May 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2022

Last Update Posted Date

Nov 16, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marc Fineberg, Chief of Sports Medicine, Associate Professor of Clinical Orthopaedics, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Name	Type	Description	Arm Group Labels	Other Names
Bioabsorbable screw fixation	Procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Adults aged 18+ who had an anterior cruciate ligament (ACL) reconstruction about 5 years ago performed by one of the study investigators.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Marc Fineberg, MD	University at Buffalo	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries

Ancestor Terms

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided