Comparison of 3 Techniques for Recreation of Anterior Cruciate Ligament Anatomic Footprint

NCT02795247 | Completed DMC

• 1 other identifier: SPORT037
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the tomographic results of patients who underwent single-bundle anterior cruciate ligament reconstruction at the investigator's institution using the transtibial, accessory medial portal technique and the modified transtibial technique to determine which technique best recreates the anterior cruciate ligament anatomic footprint.

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (1)

• 3D reconstructed CT imaging

  Used to measure tunnel position.

  6 weeks Post-Operatively

Secondary Outcomes (9)

• International Knee Documentation Committee (IKDC) Subjective Knee Evaluation

  6 weeks post-operative

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  6 weeks post-operative

• International Knee Documentation Committee (IKDC) Subjective Knee Evaluation

  6 months post-operative

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  6 months post-operative

• International Knee Documentation Committee (IKDC) Subjective Knee Evaluation

  1 year post-operative

Study Arms (3)

Hybrid Transtibial Technique

ACTIVE COMPARATOR

Reconstruction of the ACL using the hybrid transtibial technique

Procedure: Anterior Cruciate Ligament Reconstruction

Accessory Anteromedial Portal Technique

ACTIVE COMPARATOR

Reconstruction of the ACL using the accessory anteromedial portal technique

Procedure: Anterior Cruciate Ligament Reconstruction

Transtibial Technique

ACTIVE COMPARATOR

Reconstruction of the ACL using the transtibial technique.

Procedure: Anterior Cruciate Ligament Reconstruction

Interventions

Anterior Cruciate Ligament Reconstruction PROCEDURE

Also known as: ACL Reconstruction

Accessory Anteromedial Portal Technique; Hybrid Transtibial Technique; Transtibial Technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting for single bundle ACL reconstruction, with or without associated partial meniscectomy or meniscal repair.
• Skeletally mature patients
• Patients who are able and willing to receive post-operative CT imaging of the affected knee

You may not qualify if:

• Previous ACL reconstruction in the studied knee
• Previous ACL injury or reconstruction in the contralateral kneeConcomitant non-ACL ligament reconstruction or osteotomy

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina Sports Center

Charlotte, North Carolina, 28207, United States

Location

Related Publications (12)

• Robin BN, Jani SS, Marvil SC, Reid JB, Schillhammer CK, Lubowitz JH. Advantages and Disadvantages of Transtibial, Anteromedial Portal, and Outside-In Femoral Tunnel Drilling in Single-Bundle Anterior Cruciate Ligament Reconstruction: A Systematic Review. Arthroscopy. 2015 Jul;31(7):1412-7. doi: 10.1016/j.arthro.2015.01.018. Epub 2015 Mar 5.

  PMID: 25749530 BACKGROUND

• Youm YS, Cho SD, Eo J, Lee KJ, Jung KH, Cha JR. 3D CT analysis of femoral and tibial tunnel positions after modified transtibial single bundle ACL reconstruction with varus and internal rotation of the tibia. Knee. 2013 Aug;20(4):272-6. doi: 10.1016/j.knee.2012.10.024. Epub 2012 Nov 26.

  PMID: 23195998 BACKGROUND

• Lee MC, Seong SC, Lee S, Chang CB, Park YK, Jo H, Kim CH. Vertical femoral tunnel placement results in rotational knee laxity after anterior cruciate ligament reconstruction. Arthroscopy. 2007 Jul;23(7):771-8. doi: 10.1016/j.arthro.2007.04.016.

  PMID: 17637414 BACKGROUND

• Alentorn-Geli E, Lajara F, Samitier G, Cugat R. The transtibial versus the anteromedial portal technique in the arthroscopic bone-patellar tendon-bone anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2010 Aug;18(8):1013-37. doi: 10.1007/s00167-009-0964-0. Epub 2009 Nov 10.

  PMID: 19902178 BACKGROUND

• Takeda Y, Iwame T, Takasago T, Kondo K, Goto T, Fujii K, Naruse A. Comparison of tunnel orientation between transtibial and anteromedial portal techniques for anatomic double-bundle anterior cruciate ligament reconstruction using 3-dimensional computed tomography. Arthroscopy. 2013 Feb;29(2):195-204. doi: 10.1016/j.arthro.2012.08.020. Epub 2012 Dec 24.

  PMID: 23270788 BACKGROUND

• de Abreu-e-Silva GM, de Oliveira MH, Maranhao GS, Deligne Lde M, Pfeilsticker RM, Novais EN, Nunes TA, de Andrade MA. Three-dimensional computed tomography evaluation of anterior cruciate ligament footprint for anatomic single-bundle reconstruction. Knee Surg Sports Traumatol Arthrosc. 2015 Mar;23(3):770-6. doi: 10.1007/s00167-013-2703-9. Epub 2013 Oct 22.

  PMID: 24146049 BACKGROUND

• Larson AI, Bullock DP, Pevny T. Comparison of 4 femoral tunnel drilling techniques in anterior cruciate ligament reconstruction. Arthroscopy. 2012 Jul;28(7):972-9. doi: 10.1016/j.arthro.2011.12.015. Epub 2012 Mar 10.

  PMID: 22409948 BACKGROUND

• Osaki K, Okazaki K, Matsubara H, Kuwashima U, Murakami K, Iwamoto Y. Asymmetry in Femoral Tunnel Socket Length During Anterior Cruciate Ligament Reconstruction With Transportal, Outside-In, and Modified Transtibial Techniques. Arthroscopy. 2015 Dec;31(12):2365-70. doi: 10.1016/j.arthro.2015.06.026. Epub 2015 Aug 24.

  PMID: 26315055 BACKGROUND

• Bernard M, Hertel P, Hornung H, Cierpinski T. Femoral insertion of the ACL. Radiographic quadrant method. Am J Knee Surg. 1997 Winter;10(1):14-21; discussion 21-2.

  PMID: 9051173 BACKGROUND

• Forsythe B, Kopf S, Wong AK, Martins CA, Anderst W, Tashman S, Fu FH. The location of femoral and tibial tunnels in anatomic double-bundle anterior cruciate ligament reconstruction analyzed by three-dimensional computed tomography models. J Bone Joint Surg Am. 2010 Jun;92(6):1418-26. doi: 10.2106/JBJS.I.00654.

  PMID: 20516317 BACKGROUND

• Sohn OJ, Lee DC, Park KH, Ahn HS. Comparison of the Modified Transtibial Technique, Anteromedial Portal Technique and Outside-in Technique in ACL Reconstruction. Knee Surg Relat Res. 2014 Dec;26(4):241-8. doi: 10.5792/ksrr.2014.26.4.241. Epub 2014 Dec 2.

  PMID: 25505707 BACKGROUND

• Trofa DP, Saltzman BM, Corpus KT, Connor PM, Fleischli JE, Piasecki DP. A Hybrid Transtibial Technique Combines the Advantages of Anteromedial Portal and Transtibial Approaches: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Nov;48(13):3200-3207. doi: 10.1177/0363546520956645. Epub 2020 Oct 5.

  PMID: 33017169 DERIVED

MeSH Terms

Interventions

Anterior Cruciate Ligament Reconstruction

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Dana P Piasecki, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 10, 2016
• Study Start: August 26, 2016
• Primary Completion: April 27, 2018
• Study Completion: July 1, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)