Complete Tear, Knee, Anterior Cruciate LigamentNCT02374710
Tibial Tunnel Placement for ACL Reconstruction
A study testing ACL Reconstruction: Anterior Tunnel and ACL Reconstruction: Posterior Tunnel in people with Complete Tear, Knee, Anterior Cruciate Ligament and Rupture of Anterior Cruciate Ligament, run by University of Virginia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Complete Tear, Knee, Anterior Cruciate Ligament, Rupture of Anterior Cruciate Ligament
- What is being tested?
- ACL Reconstruction: Anterior Tunnel and ACL Reconstruction: Posterior Tunnel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age at time of randomization: 16 - 50 years (skeletally mature)
- Primary, uncomplicated ACL reconstruction
- Autograft (STG or BPTB)
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia, Department of Orthopedic Surgery, Division of Sports Medicine
Charlottesville, Virginia, 22903
About this study
Official title: 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.
- Being tested
- ACL Reconstruction: Anterior Tunnel, ACL Reconstruction: Posterior Tunnel
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL Reconstruction: Anterior TunnelProcedure or surgery
ACL reconstruction with anterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.
ACL Reconstruction: Posterior TunnelProcedure or surgery
ACL reconstruction with posterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.
| Study group | Role | What they receive |
|---|---|---|
| ACL Reconstruction: Anterior Tunnel | Experimental | 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. Receives: Procedure: ACL Reconstruction: Anterior Tunnel |
| ACL Reconstruction: Posterior Tunnel | Active comparator | 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. Receives: Procedure: ACL Reconstruction: Posterior Tunnel |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation
Subjective knee-specific function
Measured: 24 months
Secondary outcomes (6)
Knee Injury Outcome and Osteoarthritis Score (KOOS)
Subjective knee-specific function
Measured: 24 months
Marx Activity Rating Scale
Subjective rating of physical activity
Measured: 24 months
Visual Analog Scale (VAS)
Subjective pain
Measured: 24 months
Quadriceps Strength
Thigh muscle strength assessment
Measured: 24 months
Gait Analysis
Assessment of 3-dimensional movement patterns while walking
Measured: 24 months
Knee Arthrometer (KT-1000)
Anterior knee laxity
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complete Tear, Knee, Anterior Cruciate LigamentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Sponsor
- Investigators
- Mark D Miller, M.D., Principal investigator, University of VirginiaJoseph M Hart, Ph.D., Study director, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374710
- Sponsor's protocol ID
- 17922
- Status last verified
- May 2025
- First submitted
- 18 Feb 2015
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Staubli HU, Rauschning W. Tibial attachment area of the anterior cruciate ligament in the extended knee position. Anatomy and cryosections in vitro complemented by magnetic resonance arthrography in vivo. Knee Surg Sports Traumatol Arthrosc. 1994;2(3):138-46. doi: 10.1007/BF01467915.
PubMed 7584195Bedi A, Maak T, Musahl V, Citak M, O'Loughlin PF, Choi D, Pearle AD. Effect of tibial tunnel position on stability of the knee after anterior cruciate ligament reconstruction: is the tibial tunnel position most important? Am J Sports Med. 2011 Feb;39(2):366-73. doi: 10.1177/0363546510388157. Epub 2010 Dec 20.
PubMed 21173195Hatayama K, Terauchi M, Saito K, Higuchi H, Yanagisawa S, Takagishi K. The importance of tibial tunnel placement in anatomic double-bundle anterior cruciate ligament reconstruction. Arthroscopy. 2013 Jun;29(6):1072-8. doi: 10.1016/j.arthro.2013.02.003. Epub 2013 Apr 6.
PubMed 23571132
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tibial Tunnel Placement for ACL Reconstruction: A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02374710
- Acronym / sponsor ID
- 17922
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL Reconstruction: Anterior Tunnel | Experimental | Procedure: ACL Reconstruction: Anterior TunnelDuring 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. |
| ACL Reconstruction: Posterior Tunnel | Active comparator | Procedure: ACL Reconstruction: Posterior TunnelDuring 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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age at time of randomization: 16 - 50 years (skeletally mature)
- Primary, uncomplicated ACL reconstruction
- Autograft (STG or BPTB)
Key exclusion criteria (19 listed)
- Multiple ligament knee injury (full thickness)
- Revision ACL reconstruction
- ACL reconstruction with allograft
- Meniscectomy > 75%
- Treatable articular cartilage lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL Reconstruction: Anterior TunnelACL reconstruction with anterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia. | Procedure or surgery | ACL Reconstruction: Anterior Tunnel |
| ACL Reconstruction: Posterior TunnelACL reconstruction with posterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia. | Procedure or surgery | ACL Reconstruction: Posterior Tunnel |
Primary outcome
International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation
Time frame: 24 months
Subjective knee-specific function
6 secondary outcomes
Knee Injury Outcome and Osteoarthritis Score (KOOS)
Time frame: 24 months
Marx Activity Rating Scale
Time frame: 24 months
Visual Analog Scale (VAS)
Time frame: 24 months
Quadriceps Strength
Time frame: 24 months
Gait Analysis
Time frame: 24 months
Knee Arthrometer (KT-1000)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Results publication: PubMed 7584195Staubli HU, Rauschning W. Tibial attachment area of the anterior cruciate ligament in the extended knee position. Anatomy and cryosections in vitro complemented by magnetic resonance arthrography in vivo. Knee Surg Sports Traumatol Arthrosc. 1994;2(3):138-46. doi: 10.1007/BF01467915.
- Results publication: PubMed 21173195Bedi A, Maak T, Musahl V, Citak M, O'Loughlin PF, Choi D, Pearle AD. Effect of tibial tunnel position on stability of the knee after anterior cruciate ligament reconstruction: is the tibial tunnel position most important? Am J Sports Med. 2011 Feb;39(2):366-73. doi: 10.1177/0363546510388157. Epub 2010 Dec 20.
- Results publication: PubMed 23571132Hatayama K, Terauchi M, Saito K, Higuchi H, Yanagisawa S, Takagishi K. The importance of tibial tunnel placement in anatomic double-bundle anterior cruciate ligament reconstruction. Arthroscopy. 2013 Jun;29(6):1072-8. doi: 10.1016/j.arthro.2013.02.003. Epub 2013 Apr 6.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D Miller, M.D. principal investigator
University of Virginia
Joseph M Hart, Ph.D. study director
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL Reconstruction: Anterior Tunnel and ACL Reconstruction: Posterior Tunnel in people with Complete Tear, Knee, Anterior Cruciate Ligament and Rupture of Anterior Cruciate Ligament, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374710, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.