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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088278
• Other study ID #: Long term ACLR
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: July 27, 2023

Study information

• Verified date: July 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In the beginning, the Database of our Institute is consulted, all the patients that underwent ACL reconstruction at least 15 years ago are selected. The original group will be divided into subgroups based on the surgical technique adopted, of the different techniques we took into consideration only these three: anatomical ACL reconstruction with patellar tendon, anatomical ACL reconstruction with hamstrings, non-anatomical ACL reconstruction "Over-the-top plus lateral plasty". The patients will be contacted to ask if they are interested to take part in the study; at least 25 patients for each group will be recruited. All the patients recruited will sign an informed consent about the study and the personal data treatment. After consent acquisition, patients will undergo a clinical examination and a questionnaire about pain and knee status will be administered; moreover, a radiographical examination of the operated knee will be performed to assess the osteoarthritis progression. Patients that reported graft rupture will be registered as failures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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;

2. Patients aged between 15 and 50 at the time of surgery;

3. Patients with isolated ACL tear;

4. Patients with healthy contralateral knee at the time of surgery.

Exclusion Criteria:

1. Patients with grade III-IV chondral lesions according to Outerbridge scale at surgery;

2. Patients no longer available;

3. Women of childbearing age who cannot exclude pregnancy;

4. Patients unable to give informed consent or patients unwilling to sign informed consent.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Anatomical single bundle ACL reconstruction with hamstrings
Anatomical ACL reconstruction with quadruple-bundle hamstrings graft
• Anatomical single bundle ACL reconstruction with patellar tendon
Anatomical single bundle ACL reconstruction with patellar tendon
• ACL reconstruction with over the top plus lateral plasty technique
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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	VAS pain	Numerical score to quantitatively assess the intensity of pain (0-10)	Two years
Primary	Kellgreen-Lawrence	Radiographical score that graded knee ostheoarthritis	Two years
Primary	Knee Laxity	Assessment of knee anterior posterior laxity and quantification of Pivot shift using measurement devices (KT-1000; Kira)	Two years
Primary	Failure and complications	Failures and complication rate for each arm of the study	Two years
Secondary	Short Form-36 Health Survey	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.	Two years
Secondary	Anterior knee pain	The patients will report in dicotomic way (yes/no) the presence/absence of pain referred to patello-femural joint.	Two years
Secondary	Global satisfaction about the surgical procedure	The patients will report in dicotomic way (yes/no) if they are satisfied with the surgical procedure results	Two years
Secondary	Tight circumference	Tight circumference measured 5 cm and 15 cm above the patella; it is a direct measurement of quadriceps trophism and indirectly explore the muscular status of affected limb.	Two years
Secondary	Lysholm knee scoring scale	Clinical score used to assess knee function in context of ligamentary and meniscal lesions Values: 0 (worst score) to 100 (best score)	Two years
Secondary	Tegner activity scale	Score that graded activity based on work and sports referred to knee status Values: 0 (worst score) to 10 (best score)	Two years