Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures

Not Applicable

Completed

• Conditions: Knee Injuries
• Interventions: Procedure: Single bundle hamstring; Procedure: Double bundle hamstring; Procedure: Bone patellar tendon bone

• Registration Number: NCT00418964
• Lead Sponsor: Chinese University of Hong Kong

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 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 Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2011-06-22
• Results First Submitted QC: 2012-02-16
• Status Verified: 2012-03
• Results First Posted: 2012-03-20
• Last Update Submitted: 2012-03-22
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

Inclusion Criteria

• Men above age 18-40 years old
• First ACL reconstruction surgery
• Single leg involvement

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Exclusion Criteria

• ACL injury less than 6 weeks as deleterious effect of the injury may affect the extension range
• Injury on Duty (IOD) cases
• Other associated injuries (Fractures, other ligaments involvement, neurovascular bundles injury),Chondral lesion with co-commitment intervention
• Concomitant meniscus repair in same operation, or within 3 months before the operation
• Significant OA changes
• Known chronic disease or receiving long term medications affecting bone metabolism, including anabolic steroids, medication for thyroid hormone therapy or osteoporosis
• Neurological deficit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single bundle hamstring	Single bundle hamstring	-
Double bundle hamstring	Double bundle hamstring	-
Bone patellar tendon bone	Bone patellar tendon bone	-

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee (IKDC)Knee Form 2000 Score	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.

Secondary Outcome Measures

Name	Time	Method
Percentage Distal Femoral Bone Mineral Density (BMD)Decrease	1 year	% BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong SAR, China