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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single bundle hamstring | Experimental |
| |
| Double bundle hamstring | Experimental |
| |
| Bone patellar tendon bone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single bundle hamstring | Procedure | Single bundle hamstring |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai Ming Chan | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong SAR | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | HT-SB | Single bundle hamstring (hamstring autograft in a single bone tunnel) |
| FG001 | HT-DB | Double bundle hamstring (hamstring autograft in two bone tunnels) |
| FG002 | BPTB | Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HT-SB | Single bundle hamstring (hamstring autograft in a single bone tunnel) |
| BG001 | HT-DB | Double bundle hamstring (hamstring autograft in two bone tunnels) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Score on a scale | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HT-SB | Single bundle hamstring (hamstring autograft in a single bone tunnel) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pauline Lui | The Chinese University of Hong Kong | 852 2632 3072 | pauline@ort.cuhk.edu.hk |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D050376 | Bone-Patellar Tendon-Bone Grafting |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Double bundle hamstring |
| Procedure |
Double bundle hamstring |
|
| Bone patellar tendon bone | Procedure | Bone patellar tendon bone |
|
| BG002 | BPTB | Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BPTB |
Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel) |
|
|
| 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 | Not Posted | Mean | Standard Deviation | % | 1 year |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | HT-DB | Double bundle hamstring (hamstring autograft in two bone tunnels) | 0 | 20 | 0 | 20 |
| EG002 | BPTB | Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel) | 0 | 20 | 0 | 20 |
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| D059549 |
| Anterior Cruciate Ligament Reconstruction |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D014180 | Transplantation |