Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures

NCT ID: NCT00418964

Last Updated: 2012-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2011-06-30

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.

Conditions

Knee Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single bundle hamstring

Group Type: EXPERIMENTAL

Single bundle hamstring

Intervention Type: PROCEDURE

Single bundle hamstring

Double bundle hamstring

Group Type: EXPERIMENTAL

Double bundle hamstring

Intervention Type: PROCEDURE

Double bundle hamstring

Bone patellar tendon bone

Group Type: ACTIVE_COMPARATOR

Bone patellar tendon bone

Intervention Type: PROCEDURE

Bone patellar tendon bone

Interventions

Single bundle hamstring

Single bundle hamstring

Intervention Type: PROCEDURE

Double bundle hamstring

Double bundle hamstring

Intervention Type: PROCEDURE

Bone patellar tendon bone

Bone patellar tendon bone

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Pauline Lui

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kai Ming Chan

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong SAR, , China

Countries

China

Other Identifiers

CUHK00001

Identifier Type: -

Identifier Source: org_study_id