Complete Tear, Knee, Anterior Cruciate Ligament, Rupture of Anterior Cruciate Ligament
Conditions
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.
Interventions
PROCEDUREACL 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.
PROCEDUREACL 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.
Sponsors
University of Kentucky
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age at time of randomization: 16 - 50 years (skeletally mature) * Primary, uncomplicated ACL reconstruction * Autograft (STG or BPTB)
Exclusion criteria
* Multiple ligament knee injury (full thickness) * Revision ACL reconstruction * ACL reconstruction with allograft * Meniscectomy \> 75% * Treatable articular cartilage lesions * Diagnosis of tibiofemoral or patellofemoral osteoarthritis (Kellgren Lawrence grade \> II) * Valgus alignment on long-leg cassette (weight bearing line outside of joint center) * Prior surgery in the ankles, knees, or hips * Clinical evidence of hip disease * Patellofemoral joint instability * Significant patellar or tibiofemoral mal-alignment * BMI \> 35 * Type 1 Diabetes Mellitus * Known connective tissue disorder (e.g. Ehlers-Danlos) * Peripheral neuropathy * Neurovascular/ circulatory disorder * Any form of inflammatory arthritis (e.g. rheumatoid arthritis, gout, pseudogout, lupus, etc.) * Significant co-morbid conditions as determined by the investigator (e.g. malignancy, renal, hepatic disease, etc.) * Known or suspected psychological disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation | 24 months | Subjective knee-specific function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Knee Injury Outcome and Osteoarthritis Score (KOOS) | 24 months | Subjective knee-specific function |
| Marx Activity Rating Scale | 24 months | Subjective rating of physical activity |
Other
| Measure | Time frame | Description |
|---|---|---|
| X-Ray (AP, lateral views) | 24 months | X-ray of you knee |
| Knee Joint Range of Motion | 24 months | Knee movement measured by goniometer |
| Thigh Circumference | 24 months | Measure of your thigh using a tape measure |
Countries
United States
Outcome results
None listed