NCT00418964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 20, 2012

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

4.5 years

First QC Date

January 4, 2007

Results QC Date

June 22, 2011

Last Update Submit

March 22, 2012

Conditions

Knee Injuries

Keywords

Anterior cruciate ligament ruptureAnterior cruciate ligament(A02.513.514.100)

Outcome Measures

Primary Outcomes (1)

  • International Knee Documentation Committee (IKDC)Knee Form 2000 Score

    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.

    1 year

Secondary Outcomes (1)

  • Percentage Distal Femoral Bone Mineral Density (BMD)Decrease

    1 year

Study Arms (3)

Single bundle hamstring

EXPERIMENTAL
Procedure: Single bundle hamstring

Double bundle hamstring

EXPERIMENTAL
Procedure: Double bundle hamstring

Bone patellar tendon bone

ACTIVE COMPARATOR
Procedure: Bone patellar tendon bone

Interventions

Single bundle hamstringPROCEDURE

Single bundle hamstring

Single bundle hamstring
Double bundle hamstringPROCEDURE

Double bundle hamstring

Double bundle hamstring
Bone patellar tendon bonePROCEDURE

Bone patellar tendon bone

Bone patellar tendon bone

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men above age 18-40 years old
  • First ACL reconstruction surgery
  • Single leg involvement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong SAR, China

Location

MeSH Terms

Conditions

Knee InjuriesAnterior Cruciate Ligament Injuries

Interventions

Bone-Patellar Tendon-Bone Grafting

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsAnterior Cruciate Ligament ReconstructionArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresTransplantation

Results Point of Contact

Title
Pauline Lui
Organization
The Chinese University of Hong Kong
pauline@ort.cuhk.edu.hk
852 2632 3072

Study Officials

  • Kai Ming Chan

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 5, 2007

Study Start

December 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 27, 2012

Results First Posted

March 20, 2012

Record last verified: 2012-03

Locations

CN(1)