Long Term Clinical and Radiographical Outcomes of Different Anterior Cruciate Ligament Reconstruction Techniques

NCT05088278 | Completed

• 1 other identifier: Long term ACLR
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the long-term results of various anterior cruciate ligament reconstruction techniques. This assessment is necessary for the current context of anterior cruciate ligament research as several techniques and grafts are used in clinical practice, however, the various studies existing in the literature focus mainly only on the direct comparison of two techniques and usually with short-to-medium term follow-up. Since gonarthrosis is one of the most debated consequences of cruciate ligament reconstruction, a comparison of different long-term procedures would be desirable to have a clearer picture of the risks and benefits associated with different types of intervention.

Conditions

Anterior Cruciate Ligament Tear; Osteoarthritis, Knee

Keywords

anterior cruciate ligament; knee osteoarthritis; hamstrings; patellar tendon; lateral extra articular tenodesis

Outcome Measures

Primary Outcomes (5)

• Subjective and objective International Knee Documentation Committee

  Clinical scores widely used to assess knee function and symptoms Values: 0 (worst score) to 100 (best score) for subjective IKDC; A (best score)-B-C-D (worst score) for objective IKDC (International Knee Documentation Committee)

  Two years

• VAS pain

  Numerical score to quantitatively assess the intensity of pain (0-10)

  Two years

• Kellgreen-Lawrence

  Radiographical score that graded knee ostheoarthritis

  Two years

• Knee Laxity

  Assessment of knee anterior posterior laxity and quantification of Pivot shift using measurement devices (KT-1000; Kira)

  Two years

• Failure and complications

  Failures and complication rate for each arm of the study

  Two years

Secondary Outcomes (6)

• Short Form-36 Health Survey

  Two years

• Anterior knee pain

  Two years

• Global satisfaction about the surgical procedure

  Two years

• Tight circumference

  Two years

• Lysholm knee scoring scale

  Two years

Study Arms (3)

HS

ACTIVE COMPARATOR

Patients who underwent anatomical single-bundle ACL reconstruction with hamstrings

Procedure: Anatomical single bundle ACL reconstruction with hamstrings

BPT

ACTIVE COMPARATOR

Patients who underwent anatomical single-bundle ACL reconstruction with patellar tendon

Procedure: Anatomical single bundle ACL reconstruction with patellar tendon

Over-the-top plus lateral plasty

EXPERIMENTAL

Patients who underwent ACL reconstruction with Over-the-top plus lateral plasty technique

Procedure: ACL reconstruction with over the top plus lateral plasty technique

Interventions

Anatomical single bundle ACL reconstruction with hamstrings PROCEDURE

Anatomical ACL reconstruction with quadruple-bundle hamstrings graft

HS

Anatomical single bundle ACL reconstruction with patellar tendon PROCEDURE

Anatomical single bundle ACL reconstruction with patellar tendon

BPT

ACL reconstruction with over the top plus lateral plasty technique PROCEDURE

Non-anatomical ACL reconstruction, the hamstrings' tibial insertion is preserved; a double-bundle hamstring graft is passed intra-articularly, fixed in over the top position on the lateral femoral condyle, and then passed extra-articularly deeply to ileo-tibial band up to the tibia, where it is fixed at the level of Gerdy's tubercle.

Over-the-top plus lateral plasty

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent ACL reconstruction with single-bundle anatomical technique (patellar tendon, semitendinous and gracile tendons) or "Over-The-Top plus lateral plastic" technique and any associated procedures with at least 15 years of follow up;
• Patients aged between 15 and 50 at the time of surgery;
• Patients with isolated ACL tear;
• Patients with healthy contralateral knee at the time of surgery.

You may not qualify if:

• Patients with grade III-IV chondral lesions according to Outerbridge scale at surgery;
• Patients no longer available;
• Women of childbearing age who cannot exclude pregnancy;
• Patients unable to give informed consent or patients unwilling to sign informed consent.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (8)

• Samuelsen BT, Webster KE, Johnson NR, Hewett TE, Krych AJ. Hamstring Autograft versus Patellar Tendon Autograft for ACL Reconstruction: Is There a Difference in Graft Failure Rate? A Meta-analysis of 47,613 Patients. Clin Orthop Relat Res. 2017 Oct;475(10):2459-2468. doi: 10.1007/s11999-017-5278-9.

  PMID: 28205075 BACKGROUND

• Getgood A, Hewison C, Bryant D, Litchfield R, Heard M, Buchko G, Hiemstra LA, Willits KR, Firth A, MacDonald P; Stability Study Group. No Difference in Functional Outcomes When Lateral Extra-Articular Tenodesis Is Added to Anterior Cruciate Ligament Reconstruction in Young Active Patients: The Stability Study. Arthroscopy. 2020 Jun;36(6):1690-1701. doi: 10.1016/j.arthro.2020.02.015. Epub 2020 Mar 6.

  PMID: 32147485 BACKGROUND

• Zaffagnini S, Marcheggiani Muccioli GM, Grassi A, Roberti di Sarsina T, Raggi F, Signorelli C, Urrizola F, Spinnato P, Rimondi E, Marcacci M. Over-the-top ACL Reconstruction Plus Extra-articular Lateral Tenodesis With Hamstring Tendon Grafts: Prospective Evaluation With 20-Year Minimum Follow-up. Am J Sports Med. 2017 Dec;45(14):3233-3242. doi: 10.1177/0363546517723013. Epub 2017 Sep 18.

  PMID: 28922015 BACKGROUND

• Xie X, Xiao Z, Li Q, Zhu B, Chen J, Chen H, Yang F, Chen Y, Lai Q, Liu X. Increased incidence of osteoarthritis of knee joint after ACL reconstruction with bone-patellar tendon-bone autografts than hamstring autografts: a meta-analysis of 1,443 patients at a minimum of 5 years. Eur J Orthop Surg Traumatol. 2015 Jan;25(1):149-59. doi: 10.1007/s00590-014-1459-3. Epub 2014 Apr 21.

  PMID: 24748500 BACKGROUND

• Mouarbes D, Menetrey J, Marot V, Courtot L, Berard E, Cavaignac E. Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Outcomes for Quadriceps Tendon Autograft Versus Bone-Patellar Tendon-Bone and Hamstring-Tendon Autografts. Am J Sports Med. 2019 Dec;47(14):3531-3540. doi: 10.1177/0363546518825340. Epub 2019 Feb 21.

  PMID: 30790526 BACKGROUND

• Chen H, Liu H, Chen L. Patellar Tendon Versus 4-Strand Semitendinosus and Gracilis Autografts for Anterior Cruciate Ligament Reconstruction: A Meta-analysis of Randomized Controlled Trials With Mid- to Long-Term Follow-Up. Arthroscopy. 2020 Aug;36(8):2279-2291.e8. doi: 10.1016/j.arthro.2020.04.024. Epub 2020 May 7.

  PMID: 32387652 BACKGROUND

• Curado J, Hulet C, Hardy P, Jenny JY, Rousseau R, Lucet A, Steltzlen C, Morin V, Grimaud O, Bouguennec N, Pujol N, Sonnery-Cottet B, Graveleau N; French Society for Orthopaedic, Trauma Surgery (Societe francaise de chirurgie orthopedique et traumatologique, SoFCOT). Very long-term osteoarthritis rate after anterior cruciate ligament reconstruction: 182 cases with 22-year' follow-up. Orthop Traumatol Surg Res. 2020 May;106(3):459-463. doi: 10.1016/j.otsr.2019.09.034. Epub 2020 Feb 1.

  PMID: 32019734 BACKGROUND

• Zaffagnini S, Marcacci M, Lo Presti M, Giordano G, Iacono F, Neri MP. Prospective and randomized evaluation of ACL reconstruction with three techniques: a clinical and radiographic evaluation at 5 years follow-up. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1060-9. doi: 10.1007/s00167-006-0130-x. Epub 2006 Aug 15.

  PMID: 16909301 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Stefano Zaffagnini, MD Prof

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 21, 2021
• Study Start: April 1, 2021
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

IT (1)