Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pauline Lui, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00418964
First received: January 4, 2007
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Knee Injuries
Procedure: Single bundle hamstring
Procedure: Double bundle hamstring
Procedure: Bone patellar tendon bone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • International Knee Documentation Committee (IKDC)Knee Form 2000 Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Percentage Distal Femoral Bone Mineral Density (BMD)Decrease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    % BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery


Enrollment: 62
Study Start Date: December 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418964

Locations
China
Prince of Wales Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Kai Ming Chan Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Pauline Lui, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00418964     History of Changes
Other Study ID Numbers: CUHK00001
Study First Received: January 4, 2007
Results First Received: June 22, 2011
Last Updated: March 22, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Anterior cruciate ligament rupture
Anterior cruciate ligament(A02.513.514.100)

Additional relevant MeSH terms:
Knee Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 28, 2014