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

July 27, 2023 updated by: Istituto Ortopedico Rizzoli
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years
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.
Two years
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
Two years
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.
Two years
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)
Two years
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)
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Stefano Zaffagnini, MD Prof, Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

July 27, 2023

Study Completion (Actual)

July 27, 2023

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Long term ACLR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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