Tibial Tunnel Placement for ACL Reconstruction
Study Details
Study Description
Brief Summary
Although extensive research has been carried out on Anterior Cruciate Ligament (ACL) femoral tunnel placement, very little attention has been given to the tibial tunnel. Researchers have suggested that the tibial tunnel be placed in the center of the ACL footprint, which they described as being approximately 43% of the way (anterior-to-posterior) across the proximal tibia at its widest extent. However, others have suggested that a more anterior placement may yield improved biomechanical and clinical results. The center of the ACL footprint and the posterior aspect of the anterior horn of the lateral meniscus does not yield tibial tunnel placement a consistent percentage of the way across the tibial plateau; therefore, guidelines should be based on intraoperative fluoroscopic measurements. However, the question remaining is what percentage of the anterior-to-posterior distance across the tibia is the ideal location for the tibial tunnel in ACL reconstruction. This study will help answer that question.
Patients with a diagnosed rupture of the ACL who are scheduled for surgical reconstruction will be considered for enrollment. Eligible patients will be allocated to one of two groups based on the location of the tibial tunnel (anterior vs. posterior) during the surgical procedure. In addition to a baseline (pre-operative) evaluation, participants will return for follow-up visits at 6, 12, and 24 months post-surgery. Follow up will be completed at 24 months.
The primary objective of this study is to collect subjective and objective measures of knee-related function in patients with an anterior vs. posterior placed tibial tunnel through 24 months postoperative care.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ACL Reconstruction: Anterior Tunnel During surgery prior to ACL reconstruction, a line will be measured to indicate 35% of the anterior-to-posterior (front to back) distance of the proximal tibia. The tibial tunnel will be placed anterior (in front) of the 35% line. |
Procedure: ACL Reconstruction: Anterior Tunnel
ACL reconstruction with anterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.
|
| Active Comparator: ACL Reconstruction: Posterior Tunnel During surgery prior to ACL reconstruction, a line will be measured to indicate 35% of the anterior-to-posterior (front to back) distance of the proximal tibia. The tibial tunnel will be placed posterior (in back) of the 35% line. |
Procedure: ACL Reconstruction: Posterior Tunnel
ACL reconstruction with posterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.
|
Outcome Measures
Primary Outcome Measures
- International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation [24 months]
Subjective knee-specific function
Secondary Outcome Measures
- Knee Injury Outcome and Osteoarthritis Score (KOOS) [24 months]
Subjective knee-specific function
- Marx Activity Rating Scale [24 months]
Subjective rating of physical activity
- Godin Leisure-Time Questionnaire [24 months]
Subjective rating of physical activity
- Tegner Activity Rating [24 months]
Subjective rating of physical activity
- Tampa Scale of Kinesiophobia (TSK) [24 months]
Subjective fear of movement
- Veterans Rand 12-Item Health Survey (VR-12) [24 months]
Subjective global health and quality of life
- Visual Analog Scale (VAS) [24 months]
Subjective pain
- Quadriceps Strength [24 months]
Thigh muscle strength assessment
- Gait Analysis [24 months]
Assessment of 3-dimensional movement patterns while walking
- Knee Arthrometer (KT-1000) [24 months]
Anterior knee laxity
Other Outcome Measures
- Knee Joint Range of Motion [24 months]
- Thigh Circumference [24 months]
- X-Ray (AP, lateral views) [24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age at time of randomization: 16 - 50 years (skeletally mature)
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Primary, uncomplicated ACL reconstruction
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Autograft (STG or BPTB)
Exclusion Criteria:
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Multiple ligament knee injury (full thickness)
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Revision ACL reconstruction
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ACL reconstruction with allograft
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Meniscectomy > 75%
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Treatable articular cartilage lesions
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Diagnosis of tibiofemoral or patellofemoral osteoarthritis (Kellgren Lawrence grade > II)
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Valgus alignment on long-leg cassette (weight bearing line outside of joint center)
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Prior surgery in the ankles, knees, or hips
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Clinical evidence of hip disease
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Patellofemoral joint instability
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Significant patellar or tibiofemoral mal-alignment
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BMI > 35
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Type 1 Diabetes Mellitus
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Known connective tissue disorder (e.g. Ehlers-Danlos)
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Peripheral neuropathy
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Neurovascular/ circulatory disorder
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Any form of inflammatory arthritis (e.g. rheumatoid arthritis, gout, pseudogout, lupus, etc.)
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Significant co-morbid conditions as determined by the investigator (e.g. malignancy, renal, hepatic disease, etc.)
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Known or suspected psychological disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Virginia, Department of Orthopedic Surgery, Division of Sports Medicine | Charlottesville | Virginia | United States | 22903 |
Sponsors and Collaborators
- University of Virginia
- University of Kentucky
Investigators
- Principal Investigator: Mark D Miller, M.D., University of Virginia
- Study Director: Joseph M Hart, Ph.D., University of Virginia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17922