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

Study Overview
=================
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.

Detailed 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.

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

Conditions
-----------------
Anterior Cruciate Ligament Tear, Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Procedure: Anatomical single bundle ACL reconstruction with hamstrings
* Procedure: Anatomical single bundle ACL reconstruction with patellar tendon
* Procedure: ACL reconstruction with over the top plus lateral plasty technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HS<br>Patients who underwent anatomical single-bundle ACL reconstruction with hamstrings | Procedure: Anatomical single bundle ACL reconstruction with hamstrings<br>* Anatomical ACL reconstruction with quadruple-bundle hamstrings graft<br>|
| Active Comparator: BPT<br>Patients who underwent anatomical single-bundle ACL reconstruction with patellar tendon | Procedure: Anatomical single bundle ACL reconstruction with patellar tendon<br>* Anatomical single bundle ACL reconstruction with patellar tendon<br>|
| Experimental: Over-the-top plus lateral plasty<br>Patients who underwent ACL reconstruction with Over-the-top plus lateral plasty technique | Procedure: ACL reconstruction with over the top plus lateral plasty technique<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Anterior knee pain | The patients will report in dicotomic way (yes/no) the presence/absence of pain referred to patello-femural joint. | Two years | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hamstrings, anterior cruciate ligament, knee osteoarthritis, patellar tendon, lateral extra articular tenodesis