Trial Outcomes & Findings for Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures (NCT NCT00418964)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

1 year

Results posted on

2012-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	HT-SB Single bundle hamstring (hamstring autograft in a single bone tunnel)	HT-DB Double bundle hamstring (hamstring autograft in two bone tunnels)	BPTB Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
Overall Study STARTED	22	20	20
Overall Study COMPLETED	21	17	14
Overall Study NOT COMPLETED	1	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HT-SB n=22 Participants Single bundle hamstring (hamstring autograft in a single bone tunnel)	HT-DB n=20 Participants Double bundle hamstring (hamstring autograft in two bone tunnels)	BPTB n=20 Participants Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	62 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	23.2 years STANDARD_DEVIATION 5.0 • n=5 Participants	26.4 years STANDARD_DEVIATION 4.9 • n=7 Participants	26.5 years STANDARD_DEVIATION 5.0 • n=5 Participants	25.1 years STANDARD_DEVIATION 4.8 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	62 Participants n=4 Participants
Region of Enrollment China	22 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	62 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 year

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.

Outcome measures

Outcome measures
Measure	HT-SB n=21 Participants Single bundle hamstring (hamstring autograft in a single bone tunnel)	HT-DB n=17 Participants Double bundle hamstring (hamstring autograft in two bone tunnels)	BPTB n=14 Participants Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
International Knee Documentation Committee (IKDC)Knee Form 2000 Score	85.7 Score on a scale Standard Deviation 8.4	87.2 Score on a scale Standard Deviation 12.8	84.6 Score on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: 1 year

% BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery

Outcome measures

Outcome data not reported

Adverse Events

HT-SB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HT-DB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BPTB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pauline Lui

The Chinese University of Hong Kong

Phone: 852 2632 3072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place