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ACL InjuryLCA Over 50NCT07387939

ACL Reconstruction in Patients Aged 50 Years and Older

An observational study of ACL Injury, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ACL Injury
How many people
56 participants
Where
1 siteItaly
Study dates
16 Jan 2024to 1 Feb 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent ACl reconstruction

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    Milan, Milan

Other trials in Italy

About this study

Official title: 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.

Read more

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.

Conditions
ACL Injury
Keywords
knee, anterior cruciate ligament, ACL reconstruction, elderly patients
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07387939
Study groupRoleWhat they receive
Over 50ACL reconstructed patients over 50 years of age
ACl under 40ACL reconstructed patients under 40 years of age

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Knee Documentation Committee (IKDC) subjective form

    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).

    Measured: Through study completion, an average of 2 years

Secondary outcomes (2)
  1. ACL-RSI (Anterior Cruciate Ligament-Return to Sport after Injury) scale

    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

    Measured: Through study completion, an average of 2 years

  2. Tegner activity level

    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)

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start16 Jan 2024
  3. Primary completion12 Dec 2025
  4. Study completion1 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07387939
Sponsor's protocol ID
LCA Over 50
Acronym
LCA Over 50
Status last verified
Jan 2026
First submitted
8 Jan 2026
Last updated
4 Feb 2026
Results posted
No
Individual data sharing
No

Publications

  • Panisset JC, Gonzalez JF, de Lavigne C, Ode Q, Dejour D, Ehlinger M, Fayard JM, Lustig S; French Arthroscopic Society. ACL reconstruction in over-50 year-olds: Comparative study between prospective series of over-50 year-old and under-40 year-old patients. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S259-S265. doi: 10.1016/j.otsr.2019.09.009. Epub 2019 Oct 21.

    PubMed 31648996
  • Figueroa D, Figueroa F, Calvo R, Vaisman A, Espinoza G, Gili F. Anterior cruciate ligament reconstruction in patients over 50 years of age. Knee. 2014 Dec;21(6):1166-8. doi: 10.1016/j.knee.2014.08.003. Epub 2014 Aug 28.

    PubMed 25174853
  • Ehlinger M, Panisset JC, Dejour D, Gonzalez JF, Paihle R, Favreau H, Ollivier M, Lustig S; Francophone Arthroscopy Society (SFA). Anterior cruciate ligament reconstruction in the over-50s. A prospective comparative study between surgical and functional treatment. Orthop Traumatol Surg Res. 2021 Dec;107(8S):103039. doi: 10.1016/j.otsr.2021.103039. Epub 2021 Aug 8.

    PubMed 34375770
  • Salesky MA, Oeding JF, Zhang AL, Ma CB, Feeley BT, Lansdown DA. Patients Aged 50 Years and Older Have Greater Complication Rates After Anterior Cruciate Ligament Reconstruction: A Large Database Study. Arthrosc Sports Med Rehabil. 2021 Oct 9;3(6):e1827-e1834. doi: 10.1016/j.asmr.2021.08.010. eCollection 2021 Dec.

    PubMed 34977637
  • D'Ambrosi R, Giorgino R, Corona K, Jaykumar T, Mariani I, Ursino N, Mangiavini L, Vaishya R. Hamstring tendon autografts and allografts show comparable clinical outcomes and knee stability after anterior cruciate ligament reconstruction in patients over fifty years old with no signs of osteoarthritis progression. Int Orthop. 2022 Sep;46(9):2029-2039. doi: 10.1007/s00264-022-05465-3. Epub 2022 Jun 8.

    PubMed 35672579

Questions about this trial

What is this clinical trial studying?

An observational study of ACL Injury, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Knee Documentation Committee (IKDC) subjective form (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07387939, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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