Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures

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.

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.

Study Overview

• Status: Completed
• Conditions: Knee Injuries
• Intervention / Treatment: Procedure: Single bundle hamstring; Procedure: Double bundle hamstring; Procedure: Bone patellar tendon bone

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong SAR, China
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Documentation Committee (IKDC)Knee Form 2000 Score	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.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Kai Ming Chan, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: January 4, 2007
• First Submitted That Met QC Criteria: January 4, 2007
• First Posted (Estimate): January 5, 2007

Study Record Updates

• Last Update Posted (Estimate): March 27, 2012
• Last Update Submitted That Met QC Criteria: March 22, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Anterior cruciate ligament rupture; Anterior cruciate ligament(A02.513.514.100)
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: CUHK00001