Knee Injuries
Conditions
Keywords
Anterior cruciate ligament rupture, Anterior cruciate ligament(A02.513.514.100)
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.
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, skin sensation, 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.
Interventions
PROCEDURESingle bundle hamstring
Single bundle hamstring
PROCEDUREDouble bundle hamstring
Double bundle hamstring
PROCEDUREBone patellar tendon bone
Bone patellar tendon bone
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC)Knee Form 2000 Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Distal Femoral Bone Mineral Density (BMD)Decrease | 1 year | % BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HT-SB Single bundle hamstring (hamstring autograft in a single bone tunnel) | 22 |
| HT-DB Double bundle hamstring (hamstring autograft in two bone tunnels) | 20 |
| BPTB Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel) | 20 |
| Total | 62 |
Baseline characteristics
| Characteristic | HT-DB | BPTB | HT-SB | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 22 Participants | 62 Participants |
| Age Continuous | 26.4 years STANDARD_DEVIATION 4.9 | 26.5 years STANDARD_DEVIATION 5 | 23.2 years STANDARD_DEVIATION 5 | 25.1 years STANDARD_DEVIATION 4.8 |
| Region of Enrollment China | 20 participants | 20 participants | 22 participants | 62 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 22 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HT-SB | International Knee Documentation Committee (IKDC)Knee Form 2000 Score | 85.7 Score on a scale | Standard Deviation 8.4 |
| HT-DB | International Knee Documentation Committee (IKDC)Knee Form 2000 Score | 87.2 Score on a scale | Standard Deviation 12.8 |
| BPTB | International Knee Documentation Committee (IKDC)Knee Form 2000 Score | 84.6 Score on a scale | Standard Deviation 9.9 |
Secondary
Percentage Distal Femoral Bone Mineral Density (BMD)Decrease
% BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery
Time frame: 1 year