ACL Reconstruction in Patients Aged 50 Years and Older (LCA Over 50)

January 27, 2026 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Anterior Cruciate Ligament Reconstruction in Patients Aged 50 Years and Older

Anterior cruciate ligament (ACL) injury is one of the most common knee ligament injuries in athletes, and surgical ACL reconstruction is the treatment of choice to allow patients to return to sports and recreational activities. Surgical treatment restores joint kinematics, reduces the risk of subsequent injuries, and reduces the degenerative progression of the joint. With the increasing average age, life expectancy, and physical activity levels of the population over 50, ACL injuries are also becoming more frequent in this group. Traditionally, the treatment of choice for patients over 50 has been conservative, based on muscle-strengthening exercises and rescheduling of sports activity with lifestyle modifications to accommodate the joint deficit. Furthermore, some authors have demonstrated that ACL reconstruction in older patients can lead to a higher rate of complications such as stiffness, arthrofibrosis, infections, wound healing problems, or thromboembolic risks, as well as the fact that the presence of concomitant early degenerative osteoarthritis can prevent a satisfactory outcome. Furthermore, studies have shown that nonsurgical treatment may be the most cost-effective strategy in middle-aged patients with moderate activity levels. Currently, there is no consensus regarding the appropriateness of ACL reconstruction in patients over 50, as it is unclear whether there may be greater risks or whether the procedure may lead to more postoperative complications compared to younger patients.

However, several studies have shown that in a middle-aged population with ACL deficiency, selected and motivated patients can experience significant recovery of joint function and stability after surgical reconstruction, with a satisfactory return to sports and recreational activities. There is now growing evidence that surgical treatment can offer favorable outcomes in patients over 50 in terms of knee stability and patient satisfaction, with results similar to those observed in a younger patient population.

General Objective:

The purpose of this study is to evaluate subjective and objective functional outcomes in patients over 50 undergoing ACL reconstruction, comparing them with a population under 40.

The study's hypothesis is that ACL reconstruction surgery in patients over 50 will yield satisfactory clinical results, comparable to those in patients under 40.

Primary Objective:

The purpose of this study is to evaluate subjective and objective functional outcomes in patients over 50 undergoing ACL reconstruction at least two years after surgery.

Secondary Objectives:

Comparison of results with a population under 40.

Patients to be Enrolled:

The minimum sample size was estimated using subjective IKDC assessed at various time points after surgery in a group of patients over 50 years of age as the primary endpoint. The calculation was performed in G*Power (v3.1.9.7) assuming an α error of 0.05, a power (1-β error) of 0.80, and an effect size of 0.625 (1). The minimum estimated sample size is 23 patients. Taking into account any dropouts, an additional 20% of patients will be considered, for a total of 28 patients. To evaluate the effectiveness of the intervention in patients over 50 years of age, subjective functional outcomes will be compared with those of an equal population under 40 years of age (n=28). Therefore, the study requires the enrollment of 56 total patients, 28 per group. A total of 56 patients were divided into the two groups described in the study.

Inclusion Criteria:

  • Patients who underwent ACL reconstruction surgery from 2016 to 2021 at our Institute
  • Patients who were older than 50 or younger than 40 years of age at the time of surgery
  • Signed informed consent and agreed to participate in all study procedures

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria will not be enrolled in the study:

  • Failure to provide informed consent
  • Patients undergoing combined anterior and posterior cruciate ligament reconstruction procedures, patients undergoing combined anterior cruciate ligament reconstruction and prosthetic surgery

Patients enrolled in the study, after signing the informed consent form, will be contacted again to undergo routine assessment procedures, International Knee Documentation Committee (IKDC) score, ACL-RSI (Anterior Cruciate Ligament-Return to Sport after Injury) scale and Tegner activity scale, physical examination including ROM, stability tests such as Lachman and anterior drawer. Demographic variables (i.e., age, sex, body mass index) and surgical data will be collected by an independent researcher.

Translational relevance:

With increasing life expectancy and patient functional needs, and a projected doubling of the middle-aged population by 2050, this study aims to evaluate the effectiveness of ACL reconstruction surgery in subjects over 50 years of age.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

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
    • Milan
      • Milan, Milan, Italy
        • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who underwent ACl reconstruction

Description

Inclusion Criteria:

  • Patients who underwent ACL reconstruction surgery from 2016 to 2021 at our institution
  • Patients who were older than 50 or younger than 40 years of age at the time of surgery
  • Signed informed consent and agreed to participate in all study procedures

Exclusion Criteria:

  • Non-acceptance of informed consent
  • Patients undergoing combined anterior and posterior cruciate ligament reconstruction procedures, patients undergoing combined anterior cruciate ligament reconstruction and prosthetic surgery

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Over 50
ACL reconstructed patients over 50 years of age
ACl under 40
ACL reconstructed patients under 40 years of age

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee (IKDC) subjective form
Time Frame: Through study completion, an average of 2 years
The International Knee Documentation Committee (IKDC) Subjective Knee Form is a 18-item patient-reported outcome measure used to assess knee symptoms, function, and sports activity, ranging from 0 to 100 (higher is better).
Through study completion, an average of 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ACL-RSI (Anterior Cruciate Ligament-Return to Sport after Injury) scale
Time Frame: Through study completion, an average of 2 years
The Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale was created to evaluate psychological readiness with regard to Return-to-Sport. It includes 12 items about confidence and fear relative to performance, reinjury, and returning to pre-injury sport participation. It ranges from 0 to 100, where higher scores signify greater confidence, lower fear, and better emotional readiness
Through study completion, an average of 2 years
Tegner activity level
Time Frame: Through study completion, an average of 2 years
Tegner Activity Scale (TAS) is a self-administered patient-reported measure that describes the level of work- and sports-based activity in which a patient can engage, ranging from 0 to 10 (higher is better), from Level 0 (Sick leave or disability pension because of knee problems) to Level 10 - Competitive sports: soccer, football, rugby (national or international elite)
Through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCA Over 50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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