Clinical trial NCT00418964: Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Keywords: Anterior cruciate ligament rupture
Anterior cruciate ligament(A02.513.514.100)
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2007-01-05
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: International Knee Documentation Committee (IKDC)Knee Form 2000 Score
timeFrame: 1 year
Secondary outcomes:
measure: Percentage Distal Femoral Bone Mineral Density (BMD)Decrease
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Kai Ming Chan
role: PRINCIPAL_INVESTIGATOR
References: