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.
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.
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 group | Role | What they receive |
|---|---|---|
| Over 50 | ACL reconstructed patients over 50 years of age | |
| ACl under 40 | ACL reconstructed patients under 40 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted4 Feb 2026
- Study start16 Jan 2024
- Primary completion12 Dec 2025
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 31648996Figueroa 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 25174853Ehlinger 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 34375770Salesky 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 34977637D'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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligament Reconstruction in Patients Aged 50 Years and Older
- ClinicalTrials.gov ID
- NCT07387939
- Acronym / sponsor ID
- LCA Over 50 / LCA Over 50
- Conditions
- ACL Injury
- Keywords
- knee, anterior cruciate ligament, ACL reconstruction, elderly patients
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Over 50 | – | –ACL reconstructed patients over 50 years of age |
| ACl under 40 | – | –ACL reconstructed patients under 40 years of age |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent ACl reconstruction
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
ACL-RSI (Anterior Cruciate Ligament-Return to Sport after Injury) scale
Time frame: Through study completion, an average of 2 years
Tegner activity level
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 31648996Panisset 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.
- Background: PubMed 25174853Figueroa 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.
- Background: PubMed 34375770Ehlinger 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.
- Background: PubMed 34977637Salesky 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.
- Background: PubMed 35672579D'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.