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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Tear; Osteoarthritis, Knee
• Interventions: Procedure: Anatomical single bundle ACL reconstruction with patellar tendon; Procedure: ACL reconstruction with over the top plus lateral plasty technique; Procedure: Anatomical single bundle ACL reconstruction with hamstrings

• Registration Number: NCT05088278
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-21
• Status Verified: 2023-07
• Primary Completion: 2023-07-27
• Study Completion: 2023-07-27
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPT	Anatomical single bundle ACL reconstruction with patellar tendon	Patients who underwent anatomical single-bundle ACL reconstruction with patellar tendon
Over-the-top plus lateral plasty	ACL reconstruction with over the top plus lateral plasty technique	Patients who underwent ACL reconstruction with Over-the-top plus lateral plasty technique
HS	Anatomical single bundle ACL reconstruction with hamstrings	Patients who underwent anatomical single-bundle ACL reconstruction with hamstrings

Primary Outcome Measures

Name	Time	Method
Failure and complications	Two years	Failures and complication rate for each arm of the study
Subjective and objective International Knee Documentation Committee	Two years	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)
Knee Laxity	Two years	Assessment of knee anterior posterior laxity and quantification of Pivot shift using measurement devices (KT-1000; Kira)
VAS pain	Two years	Numerical score to quantitatively assess the intensity of pain (0-10)
Kellgreen-Lawrence	Two years	Radiographical score that graded knee ostheoarthritis

Secondary Outcome Measures

Name	Time	Method
Anterior knee pain	Two years	The patients will report in dicotomic way (yes/no) the presence/absence of pain referred to patello-femural joint.
Tight circumference	Two years	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.
Lysholm knee scoring scale	Two years	Clinical score used to assess knee function in context of ligamentary and meniscal lesions Values: 0 (worst score) to 100 (best score)
Tegner activity scale	Two years	Score that graded activity based on work and sports referred to knee status Values: 0 (worst score) to 10 (best score)
Short Form-36 Health Survey	Two years	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.
Global satisfaction about the surgical procedure	Two years	The patients will report in dicotomic way (yes/no) if they are satisfied with the surgical procedure results

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy