Tibial Tunnel Placement for ACL Reconstruction
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 16 - 50 |
Updated: | 4/2/2016 |
Start Date: | April 2015 |
End Date: | April 2019 |
Contact: | Mark D Miller, M.D. |
Email: | mdm3p@hscmail.mcc.virginia.edu |
Phone: | 434-243-0278 |
Tibial Tunnel Placement for ACL Reconstruction: A Prospective, Randomized Clinical Trial
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.
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.
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
We found this trial at
1
site
Charlottesville, Virginia 22903
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