Prospective Registry of Anterior Cruciate Ligament Recons... | NCT04135950

Studies
Prospective Registry of Anterior Cruciate Ligament Reconstructions

NCT04135950

Sponsor

State University of New York at Buffalo

Status

Completed

Last Update Posted

Nov 20, 2025Actual

Enrollment

1,646Actual

Phase

Not provided

Conditions

Anterior Cruciate Ligament Tear
Meniscal Tear
Cartilage Injury
Bone Bruising

Interventions

Not provided

Countries

United States

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 2025

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

Jan 2005Actual

Primary Completion Date

Oct 28, 2025Actual

Completion Date

Oct 28, 2025Actual

First Submitted Date

Oct 21, 2019

First Submission Date that Met QC Criteria

Oct 21, 2019

First Posted Date

Oct 23, 2019Actual

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 18, 2025

Last Update Posted Date

Nov 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leslie Bisson, June A. and Eugene R. Mindell, MD Professor and Chair, 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

Not provided

Is FDA Regulated Device

Not provided

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 the study is to investigate factors that are associated with outcomes of injury to the anterior cruciate ligament (ACL) in the knee among patients who are undergoing surgical reconstruction. This study is a registry of all patients having knee surgery at our institution performed by 4 fellowship-trained orthopaedic surgeons. The surgeon documents patient information on standard data forms including risk factors and surgical findings.

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

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,646Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
additional injury	At the time of ACL surgery, it is determined if the patient has any other injuries to the meniscus or cartilage.	intraoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing ACL surgery

Exclusion Criteria:

Previous surgery on the affected knee
Posterior cruciate ligament injuries
Grade 2 lateral collateral ligament or medial collateral ligament injuries

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients at our institution who are having ACL surgery by one of 4 fellowship-trained surgeons will be included in this registry.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UBMD Orthopaedics and Sports Medicine		Buffalo	New York	14226	United States

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