Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00418964
Status:
COMPLETED
Last Update Posted:
2012-03-27
First Post:
2007-01-04
Brief Title:
Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Functional Clinical Radiological Outcome of Anterior Cruciate Ligament Reconstruction A Prospective Randomized Control Clinical Trial Studies Comparing Bone Patella Bone Single Bundle and Double Bundle Method
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
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:
The objective of this prospective study is to assess the clinical functional and radiological outcomes of three different ACL reconstruction procedures Bone Patella Bone graft Single bundle hamstring graft and anatomical Double bundle graft in terms of pain swelling mobility quadriceps girth size stability proprioception bone mineral density and functional status
Detailed Description:
Anterior cruciate ligament ACL reconstruction surgery is one of the common procedures performed by orthopedic surgeons with approximately 100000 cases performed per year in the United States A large amount of sports injuries were related to ACL problem As such ACL injuries and treatment is still widely under intensive study
Traditionally ACL surgery has been focused on using bone patella bone graft and single bundle hamstring graft Problems of knee pain unstable fixation rotational instability and degenerative changes were reported Recently the use of double bundle hamstring graft to reconstruct the ACL according its anatomy aiming to improve the rotational stability was proposed However results about the clinical functional and radiological outcomes are limited
The objective of this prospective pilot study is to assess the clinical functional and radiological outcomes of three different ACL reconstruction procedures Bone Patella Bone graft Single bundle hamstring graft and anatomical Double bundle graft in terms of pain swelling mobility quadriceps girth size stability proprioception skin sensation bone mineral density and functional status
Subjects to be operated for ACL reconstruction and meeting the inclusion and exclusion criteria will be recruited Subjects will be randomly assigned to the three surgical groups by block randomization Demographic information parameters in recovery domain functional domain and stability domain isokinetic test motion analysis domain proprioception and radiographical measurements will be made at baseline and at day 1 week 2 week 4 week 8 month 3 month 5 1 year and 2 years post-surgery The effect of different surgical techniques and time on the different outcomes will be analysed by 2-way ANOVA
Traditionally ACL surgery has been focused on using bone patella bone graft and single bundle hamstring graft Problems of knee pain unstable fixation rotational instability and degenerative changes were reported Recently the use of double bundle hamstring graft to reconstruct the ACL according its anatomy aiming to improve the rotational stability was proposed However results about the clinical functional and radiological outcomes are limited
The objective of this prospective pilot study is to assess the clinical functional and radiological outcomes of three different ACL reconstruction procedures Bone Patella Bone graft Single bundle hamstring graft and anatomical Double bundle graft in terms of pain swelling mobility quadriceps girth size stability proprioception skin sensation bone mineral density and functional status
Subjects to be operated for ACL reconstruction and meeting the inclusion and exclusion criteria will be recruited Subjects will be randomly assigned to the three surgical groups by block randomization Demographic information parameters in recovery domain functional domain and stability domain isokinetic test motion analysis domain proprioception and radiographical measurements will be made at baseline and at day 1 week 2 week 4 week 8 month 3 month 5 1 year and 2 years post-surgery The effect of different surgical techniques and time on the different outcomes will be analysed by 2-way ANOVA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None