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Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures

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ClinicalTrials.gov Identifier: NCT00418964
Recruitment Status : Completed
First Posted : January 5, 2007
Results First Posted : March 20, 2012
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
Pauline Lui, Chinese University of Hong Kong

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Knee Injuries
Interventions Procedure: Single bundle hamstring
Procedure: Double bundle hamstring
Procedure: Bone patellar tendon bone
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HT-SB HT-DB BPTB
Hide Arm/Group Description Single bundle hamstring (hamstring autograft in a single bone tunnel) Double bundle hamstring (hamstring autograft in two bone tunnels) Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
Period Title: Overall Study
Started 22 20 20
Completed 21 17 14
Not Completed 1 3 6
Arm/Group Title HT-SB HT-DB BPTB Total
Hide Arm/Group Description Single bundle hamstring (hamstring autograft in a single bone tunnel) Double bundle hamstring (hamstring autograft in two bone tunnels) Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel) Total of all reporting groups
Overall Number of Baseline Participants 22 20 20 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 20 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
20
 100.0%
20
 100.0%
62
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 20 participants 20 participants 62 participants
23.2  (5.0) 26.4  (4.9) 26.5  (5.0) 25.1  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 20 participants 62 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
22
 100.0%
20
 100.0%
20
 100.0%
62
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 22 participants 20 participants 20 participants 62 participants
22 20 20 62
1.Primary Outcome
Title International Knee Documentation Committee (IKDC)Knee Form 2000 Score
Hide Description 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.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HT-SB HT-DB BPTB
Hide Arm/Group Description:
Single bundle hamstring (hamstring autograft in a single bone tunnel)
Double bundle hamstring (hamstring autograft in two bone tunnels)
Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
Overall Number of Participants Analyzed 21 17 14
Mean (Standard Deviation)
Unit of Measure: Score on a scale
85.7  (8.4) 87.2  (12.8) 84.6  (9.9)
2.Secondary Outcome
Title Percentage Distal Femoral Bone Mineral Density (BMD)Decrease
Hide Description % BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery
Time Frame 1 year
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HT-SB HT-DB BPTB
Hide Arm/Group Description Single bundle hamstring (hamstring autograft in a single bone tunnel) Double bundle hamstring (hamstring autograft in two bone tunnels) Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
All-Cause Mortality
HT-SB HT-DB BPTB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HT-SB HT-DB BPTB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HT-SB HT-DB BPTB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Pauline Lui
Organization: The Chinese University of Hong Kong
Phone: 852 2632 3072
Responsible Party: Pauline Lui, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00418964     History of Changes
Other Study ID Numbers: CUHK00001
First Submitted: January 4, 2007
First Posted: January 5, 2007
Results First Submitted: June 22, 2011
Results First Posted: March 20, 2012
Last Update Posted: March 27, 2012