Muscle Preservation Hamstring Graft for ACL Reconstruction

Muscle Preservation Hamstring Graft for ACL Reconstruction: Randomized Controlled Trial

• 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

Study Overview

• Status: Unknown
• Conditions: Graft Healing
• Intervention / Treatment: Procedure: Muscle preservation; Procedure: No muscle preservation

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JIN KYU LEE, MD; Phone Number: 820222908485; Email: gaia-silver@hnamail.net

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Hanyang University Seoul Hospital
    • Contact: JIN KYU LEE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muscle preservation; Muscle preservation for hamsting graft	Procedure: Muscle preservation; Muscle preservation during graft preparation of hamstring graft
Active Comparator: None preservation; No muscle preservation for hamstring graft	Procedure: No muscle preservation; No muscle preservation during graft preparation of hamstring graft

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanyang University Seoul Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: muscle preservation study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no planned for now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No