Muscle Preservation Hamstring Graft for ACL Reconstruction | NCT03998904

Studies
Muscle Preservation Hamstring Graft for ACL Reconstruction

NCT03998904

Sponsor

Hanyang University Seoul Hospital

Status

Unknown status

Last Update Posted

Jun 26, 2019Actual

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Graft Healing

Interventions

Muscle preservation
No muscle preservation

Countries

South Korea

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

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Jun 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Jun 25, 2019

First Submission Date that Met QC Criteria

Jun 25, 2019

First Posted Date

Jun 26, 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

Jun 25, 2019

Last Update Posted Date

Jun 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

JIN KYU LEE, professor, Hanyang University Seoul HospitalPrincipal Investigator

Lead Sponsor

Hanyang University Seoul HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Muscle derived stem cell is a better source of stem cells than a tendon tissue
Preservation of muscle derived stem cell may enhance bone-tendon integration and ligamentization of ACL hamstring graft

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Muscle preservation	Experimental	Muscle preservation for hamsting graft	Procedure: Muscle preservation
None preservation	Active Comparator	No muscle preservation for hamstring graft	Procedure: No muscle preservation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Muscle preservation	Procedure	Muscle preservation during graft preparation of hamstring graft	Muscle preservation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SNQ value of MRI	signal of ACL graft-signal of quadriceps tendon/singal of background	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary ACL reconstruction using autogenous hamstring graft

Exclusion Criteria:

Combined meniscal or ligament surgery
Combined osteoarthritis (KL grade II or more)
chondral injury more than grade 2
Refuse to undergo MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JIN KYU LEE, MD	Contact	820222908485		gaia-silver@hnamail.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University Seoul Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

no planned for now

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided