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Tibial Tunnel Placement for ACL Reconstruction

Primary Purpose

Complete Tear, Knee, Anterior Cruciate Ligament, Rupture of Anterior Cruciate Ligament

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACL Reconstruction: Anterior Tunnel
ACL Reconstruction: Posterior Tunnel
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complete Tear, Knee, Anterior Cruciate Ligament

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia, Department of Orthopedic Surgery, Division of Sports MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACL Reconstruction: Anterior Tunnel

ACL Reconstruction: Posterior Tunnel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation
Subjective knee-specific function

Secondary Outcome Measures

Knee Injury Outcome and Osteoarthritis Score (KOOS)
Subjective knee-specific function
Marx Activity Rating Scale
Subjective rating of physical activity
Godin Leisure-Time Questionnaire
Subjective rating of physical activity
Tegner Activity Rating
Subjective rating of physical activity
Tampa Scale of Kinesiophobia (TSK)
Subjective fear of movement
Veterans Rand 12-Item Health Survey (VR-12)
Subjective global health and quality of life
Visual Analog Scale (VAS)
Subjective pain
Quadriceps Strength
Thigh muscle strength assessment
Gait Analysis
Assessment of 3-dimensional movement patterns while walking
Knee Arthrometer (KT-1000)
Anterior knee laxity

Full Information

First Posted
February 18, 2015
Last Updated
April 16, 2015
Sponsor
University of Virginia
Collaborators
University of Kentucky
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1. Study Identification

Unique Protocol Identification Number
NCT02374710
Brief Title
Tibial Tunnel Placement for ACL Reconstruction
Official Title
Tibial Tunnel Placement for ACL Reconstruction: A Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
University of Kentucky

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Tear, Knee, Anterior Cruciate Ligament, Rupture of Anterior Cruciate Ligament

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACL Reconstruction: Anterior Tunnel
Arm Type
Experimental
Arm Description
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.
Arm Title
ACL Reconstruction: Posterior Tunnel
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ACL Reconstruction: Anterior Tunnel
Intervention Description
ACL reconstruction with anterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.
Intervention Type
Procedure
Intervention Name(s)
ACL Reconstruction: Posterior Tunnel
Intervention Description
ACL reconstruction with posterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.
Primary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation
Description
Subjective knee-specific function
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Knee Injury Outcome and Osteoarthritis Score (KOOS)
Description
Subjective knee-specific function
Time Frame
24 months
Title
Marx Activity Rating Scale
Description
Subjective rating of physical activity
Time Frame
24 months
Title
Godin Leisure-Time Questionnaire
Description
Subjective rating of physical activity
Time Frame
24 months
Title
Tegner Activity Rating
Description
Subjective rating of physical activity
Time Frame
24 months
Title
Tampa Scale of Kinesiophobia (TSK)
Description
Subjective fear of movement
Time Frame
24 months
Title
Veterans Rand 12-Item Health Survey (VR-12)
Description
Subjective global health and quality of life
Time Frame
24 months
Title
Visual Analog Scale (VAS)
Description
Subjective pain
Time Frame
24 months
Title
Quadriceps Strength
Description
Thigh muscle strength assessment
Time Frame
24 months
Title
Gait Analysis
Description
Assessment of 3-dimensional movement patterns while walking
Time Frame
24 months
Title
Knee Arthrometer (KT-1000)
Description
Anterior knee laxity
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Knee Joint Range of Motion
Time Frame
24 months
Title
Thigh Circumference
Time Frame
24 months
Title
X-Ray (AP, lateral views)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark D Miller, M.D.
Phone
434-243-0278
Email
mdm3p@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph M Hart, Ph.D.
Phone
434-924-6187
Email
jmh3zf@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Miller, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph M Hart, Ph.D.
Organizational Affiliation
University of Virginia
Official's Role
Study Director
Facility Information:
Facility Name
University of Virginia, Department of Orthopedic Surgery, Division of Sports Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark D Miller, M.D
Phone
434-243-0278
Email
mdm3p@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Joseph M Hart, Ph.D.
Phone
434-924-6187
Email
jmh3zf@hscmail.mcc.virginia.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
7584195
Citation
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.
Results Reference
result
PubMed Identifier
21173195
Citation
Bedi 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 Reference
result
PubMed Identifier
23571132
Citation
Hatayama 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.
Results Reference
result

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Tibial Tunnel Placement for ACL Reconstruction

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