Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-29 @ 10:11 AM
Study NCT ID:
NCT03171532
Status:
UNKNOWN
Last Update Posted:
2017-05-31
First Post:
2017-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament Reconstruction
Sponsor:
National University Hospital, Singapore
Organization:
Study Overview
Official Title:
Comparison of Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament (ACL) Reconstruction: A Prospective Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to study differences in clinical and functional outcomes at 2 years based on hamstring graft size after single bundle anatomic ACL reconstruction using either 4-strand or 5-strand hamstring grafts. We also propose to study the characteristics of hamstring graft in our subset of patients in Asian population context.
Detailed Description:
This will be a prospective, randomized interventional study conducted at the National University Hospital under University Orthopaedics and Hand surgery Cluster during the period of December 2015 to December 2018. Study participants: The study will include 80 patients with complete Anterior Cruciate Ligament (ACL) tear undergoing primary arthroscopic reconstruction with ipsilateral hamstring autograft after written informed consent to participate in the study.
The subjects will be divided into two groups A) 4-strand hamstring or B) 5-strand hamstring group by block randomization using an online randomization generator (http://www.graphpad.com/quickcalcs). All the subjects will undergo the procedure by otherwise identical technique performed by single surgeon. At 1 and 2 years functional and subjective outcomes will be assessed.
The subjects will be divided into two groups A) 4-strand hamstring or B) 5-strand hamstring group by block randomization using an online randomization generator (http://www.graphpad.com/quickcalcs). All the subjects will undergo the procedure by otherwise identical technique performed by single surgeon. At 1 and 2 years functional and subjective outcomes will be assessed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: