Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures
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|ClinicalTrials.gov Identifier: NCT00418964|
Recruitment Status : Completed
First Posted : January 5, 2007
Results First Posted : March 20, 2012
Last Update Posted : March 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Knee Injuries||Procedure: Single bundle hamstring Procedure: Double bundle hamstring Procedure: Bone patellar tendon bone||Not Applicable|
Anterior cruciate ligament (ACL) reconstruction surgery is one of the common procedures performed by orthopedic surgeons with approximately 100,000 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
|Experimental: Single bundle hamstring||
Procedure: Single bundle hamstring
Single bundle hamstring
|Experimental: Double bundle hamstring||
Procedure: Double bundle hamstring
Double bundle hamstring
|Active Comparator: Bone patellar tendon bone||
Procedure: Bone patellar tendon bone
Bone patellar tendon bone
- International Knee Documentation Committee (IKDC)Knee Form 2000 Score [ Time Frame: 1 year ]It is a score on a scale from 0 to 100. It is a knee-specific measure of symptoms, function and sports activity of subjects based on self-report. 0 represents the worst while 100 represents the best score. The higher the score, the better the knee function.
- Percentage Distal Femoral Bone Mineral Density (BMD)Decrease [ Time Frame: 1 year ]% BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418964
|Prince of Wales Hospital|
|Hong Kong SAR, China|
|Principal Investigator:||Kai Ming Chan||Chinese University of Hong Kong|