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

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Anterior Cruciate Ligament Tear; Osteoarthritis, Knee

Treatments: Procedure: ACL reconstruction with over the top plus lateral plasty technique; Procedure: Anatomical single bundle ACL reconstruction with hamstrings; Procedure: Anatomical single bundle ACL reconstruction with patellar tendon

Study type: Interventional

Funder types: Other

Identifiers

NCT05088278

Long term ACLR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

HS

Active Comparator group

Description:

Patients who underwent anatomical single-bundle ACL reconstruction with hamstrings

Treatment:

Procedure: Anatomical single bundle ACL reconstruction with hamstrings

BPT

Active Comparator group

Description:

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

Treatment:

Procedure: Anatomical single bundle ACL reconstruction with patellar tendon

Over-the-top plus lateral plasty

Experimental group

Description:

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

Treatment:

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