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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-07-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anterior Cruciate Ligament Tear Osteoarthritis, Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HS

Patients who underwent anatomical single-bundle ACL reconstruction with hamstrings

Group Type ACTIVE_COMPARATOR

Anatomical single bundle ACL reconstruction with hamstrings

Intervention Type PROCEDURE

Anatomical ACL reconstruction with quadruple-bundle hamstrings graft

BPT

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

Group Type ACTIVE_COMPARATOR

Anatomical single bundle ACL reconstruction with patellar tendon

Intervention Type PROCEDURE

Anatomical single bundle ACL reconstruction with patellar tendon

Over-the-top plus lateral plasty

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

Group Type EXPERIMENTAL

ACL reconstruction with over the top plus lateral plasty technique

Intervention Type 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.

Interventions

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Anatomical single bundle ACL reconstruction with hamstrings

Anatomical ACL reconstruction with quadruple-bundle hamstrings graft

Intervention Type PROCEDURE

Anatomical single bundle ACL reconstruction with patellar tendon

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No