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Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures

This study is currently recruiting participants.
Verified by Chinese University of Hong Kong, January 2007

Sponsored by: Chinese University of Hong Kong
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00418964
  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: Three anterior cruciate ligament reconstructive procedures

MedlinePlus related topics:   Knee Injuries and Disorders   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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.

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

Primary Outcome Measures:
  • The IKDC score as assessed two years after surgery will be used as the primary outcome of this study.

Secondary Outcome Measures:
  • Pain level, range of motion, girth measurement, ambulatory state, IKDC, Lysholm score, KT-1000, Lachman test, isokinetic test, motion analysis, knee repositioning, balance master, x-Ray and DXA at day 1, week 2, 4, 8, month, month 3, 5, 12 and 24.

Estimated Enrollment:   32
Study Start Date:   December 2006
Estimated Study Completion Date:   November 2008

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, 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
  • Injury more than 1 year
  • 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

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

Contacts
Contact: Patrick Yung     852-26322706     Patrick@ort.cuhk.edu.hk    

Locations
China
Prince of Wales Hospital     Recruiting
      Hong Kong SAR, China
      Contact: Kai Ming Chan     852-26322728     kaimingchan@cuhk.edu.hk    

Sponsors and Collaborators
Chinese University of Hong Kong

Investigators
Principal Investigator:     Kai Ming Chan     Chinese University of Hong Kong    
  More Information


Study ID Numbers:   CUHK00001
First Received:   January 4, 2007
Last Updated:   January 4, 2007
ClinicalTrials.gov Identifier:   NCT00418964
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)  

Study placed in the following topic categories:
Wounds and Injuries
Disorders of Environmental Origin
Knee Injuries
Rupture
Leg Injuries

ClinicalTrials.gov processed this record on September 23, 2008




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