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Completed

NCT Number: NCT05088278

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

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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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anatomical single bundle ACL reconstruction with hamstrings

Procedure

Anatomical ACL reconstruction with quadruple-bundle hamstrings graft

Anatomical single bundle ACL reconstruction with patellar tendon

Procedure

Anatomical single bundle ACL reconstruction with patellar tendon

ACL reconstruction with over the top plus lateral plasty technique

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.

Primary outcomes

  1. Subjective and objective International Knee Documentation Committee

    Time frame: 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)

  2. VAS pain

    Time frame: Two years

    Numerical score to quantitatively assess the intensity of pain (0-10)

  3. Kellgreen-Lawrence

    Time frame: Two years

    Radiographical score that graded knee ostheoarthritis

  4. Knee Laxity

    Time frame: Two years

    Assessment of knee anterior posterior laxity and quantification of Pivot shift using measurement devices (KT-1000; Kira)

  5. Failure and complications

    Time frame: Two years

    Failures and complication rate for each arm of the study

Secondary outcomes

  1. Short Form-36 Health Survey

    Time frame: 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.

  2. Anterior knee pain

    Time frame: Two years

    The patients will report in dicotomic way (yes/no) the presence/absence of pain referred to patello-femural joint.

  3. Global satisfaction about the surgical procedure

    Time frame: Two years

    The patients will report in dicotomic way (yes/no) if they are satisfied with the surgical procedure results

  4. Tight circumference

    Time frame: 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.

  5. Lysholm knee scoring scale

    Time frame: Two years

    Clinical score used to assess knee function in context of ligamentary and meniscal lesions Values: 0 (worst score) to 100 (best score)

  6. Tegner activity scale

    Time frame: Two years

    Score that graded activity based on work and sports referred to knee status Values: 0 (worst score) to 10 (best score)

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2021
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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