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N/A N=62 Randomized Treatment

Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures

Knee Injuries

Bottom Line

View on ClinicalTrials.gov: NCT00418964 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: International Knee Documentation Committee (IKDC)Knee Form 2000 Score — 85.7; 87.2; 84.6 Score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Single bundle hamstring (Procedure); Double bundle hamstring (Procedure); Bone patellar tendon bone (Procedure)
Age
Adult · 18+ yrs
Sex
Male
Sponsor
Chinese University of Hong Kong
Primary completion
Jun 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
International Knee Documentation Committee (IKDC)Knee Form 2000 Score		 85.7; 87.2; 84.6 —
SECONDARY
Percentage Distal Femoral Bone Mineral Density (BMD)Decrease		 — —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00418964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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