Knee Ligament InjuryMULTI-LIGNCT06522659
Evaluation of Clinical and Radiographic Outcomes of Surgically Treated Multiligamentous Knee Injuries
An observational study of Knee Ligament Injury and PCL - Posterior Cruciate Ligament Rupture, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Multiligament knee injuries are typically caused by high-energy mechanisms and are classified according to the number of ligaments involved using Schenk's classification (Knee Dislocation) into KD 1, KD 2, KD 3, and KD 4. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Ligament Injury, PCL - Posterior Cruciate Ligament Rupture, PROMs
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2021to 2 Mar 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from all subjects treated surgically with multiligament knee reconstruction techniques from January 1, 2000, to December 31, 2019, at the Rizzoli Orthopedic Institute.
Who may be able to join
- Patients aged between 18 and 65 years at the time of surgery
- Male and female gender
- Patients undergoing multiligamentous knee reconstruction from January 1, 2000, to December 31, 2019, at the Rizzoli Orthopedic Institute.
Who cannot join
- Patients no longer reachable;
- Patients who do not consent to be included in the study;
- Pregnant women;
- Presence of infection or hematologic, rheumatic, or coagulative disorders at the time of evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Multiligament knee injuries are typically caused by high-energy mechanisms and are classified according to the number of ligaments involved using Schenk's classification (Knee Dislocation) into KD 1, KD 2, KD 3, and KD 4. These types of injuries can have devastating consequences on the individual's quality of life, affecting their ability to return to sports and perform daily activities.
In the literature, there is still no consensus on the management of these types of traumas, both due to the wide range of situations that can present to the orthopedic surgeon and the difficulty in their diagnostic and therapeutic framing. The main controversies concern the conservative or surgical management of the injuries and the timing of when to undertake surgical treatment, if at all.
Read more
The instability resulting from multiligament knee injuries is poorly tolerated by patients, who find their daily activities limited. It is also well known that this instability can dramatically accelerate the development of osteoarthritis, leading to the need for joint replacement surgery even in young individuals, thus increasing the likelihood of revisions and re-operations over time.
Due to the lack of standardized and satisfactory treatment, the economic cost of the outcomes of multiligament knee injuries is particularly high. A recent study by XXX showed that only XXX% of individuals are able to return to work. The rate of participation in sports is even lower, which has a long-term potential impact by increasing the risk of sedentary lifestyle-related diseases such as obesity, diabetes, and cardiovascular diseases.
The choice of surgical treatment aims to eliminate the patient's subjective feeling of instability and to repair, when possible, or reconstruct the injured ligament structures to reduce the risk of secondary osteoarthritis. Available studies in the literature are often case reports presenting short- and medium-term results of non-standardized surgical techniques with great heterogeneity in rehabilitation protocols, so the real long-term effectiveness of these treatments in terms of joint stability and osteoarthritis prevention is not known.
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC)
The IKDC form assesses knee function and symptoms across three domains: Symptoms (pain, stiffness, swelling, locking), Sports and daily activities, and Current knee function compared to before injury. It includes 10 questions: seven on symptoms, one on sports, one on daily activity difficulties, and one on current knee function. Scores range from 0 to 100, with higher scores indicating better knee function (excellent: 80-100, good: 60-80, fair: 30-60, poor: 0-30).
Measured: 5 years
Secondary outcomes (1)
Lysholm Knee Score
It is a validated measurement scale that assesses knee functionality through 8 items that determine the condition of the knee in response to the functional demands of daily life activities. This evaluation form is used to assess the surgical outcomes in patients who have undergone surgery for ligament or meniscal injuries of the knee.
The final score is obtained by summing the various scores from the different items, ranging from 0 to 100. Scores are divided into subgroups: Excellent (95-100), Good (84-94), Fair (65-83), and Poor (<64).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start31 Mar 2021
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522659
- Sponsor's protocol ID
- MULTI-LIG
- Acronym
- MULTI-LIG
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Radiographic Outcomes of Surgically Treated Multiligamentous Knee Injuries
- ClinicalTrials.gov ID
- NCT06522659
- Acronym / sponsor ID
- MULTI-LIG / MULTI-LIG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 26 Jul 2024 (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.
Multiligament knee injuries are typically caused by high-energy mechanisms and are classified according to the number of ligaments involved using Schenk's classification (Knee Dislocation) into KD 1, KD 2, KD 3, and KD 4. These types of injuries can have devastating consequences on the individual's quality of life, affecting their ability to return to sports and perform daily activities.
In the literature, there is still no consensus on the management of these types of traumas, both due to the wide range of situations that can present to the orthopedic surgeon and the difficulty in their diagnostic and therapeutic framing. The main controversies concern the conservative or surgical management of the injuries and the timing of when to undertake surgical treatment, if at all.
The instability resulting from multiligament knee injuries is poorly tolerated by patients, who find their daily activities limited. It is also well known that this instability can dramatically accelerate the development of osteoarthritis, leading to the need for joint replacement surgery even in young individuals, thus increasing the likelihood of revisions and re-operations over time.
Due to the lack of standardized and satisfactory treatment, the economic cost of the outcomes of multiligament knee injuries is particularly high. A recent study by XXX showed that only XXX% of individuals are able to return to work. The rate of participation in sports is even lower, which has a long-term potential impact by increasing the risk of sedentary lifestyle-related diseases such as obesity, diabetes, and cardiovascular diseases.
The choice of surgical treatment aims to eliminate the patient's subjective feeling of instability and to repair, when possible, or reconstruct the injured ligament structures to reduce the risk of secondary osteoarthritis. Available studies in the literature are often case reports presenting short- and medium-term results of non-standardized surgical techniques with great heterogeneity in rehabilitation protocols, so the real long-term effectiveness of these treatments in terms of joint stability and osteoarthritis prevention is not known.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from all subjects treated surgically with multiligament knee reconstruction techniques from January 1, 2000, to December 31, 2019, at the Rizzoli Orthopedic Institute.
Key inclusion criteria (3 listed)
- Patients aged between 18 and 65 years at the time of surgery
- Male and female gender
- Patients undergoing multiligamentous knee reconstruction from January 1, 2000, to December 31, 2019, at the Rizzoli Orthopedic Institute.
Key exclusion criteria (4 listed)
- Patients no longer reachable;
- Patients who do not consent to be included in the study;
- Pregnant women;
- Presence of infection or hematologic, rheumatic, or coagulative disorders at the time of evaluation.
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)
Time frame: 5 years
The IKDC form assesses knee function and symptoms across three domains: Symptoms (pain, stiffness, swelling, locking), Sports and daily activities, and Current knee function compared to before injury. It includes 10 questions: seven on symptoms, one on sports, one on daily activity difficulties, and one on current knee function. Scores range from 0 to 100, with higher scores indicating better knee function (excellent: 80-100, good: 60-80, fair: 30-60, poor: 0-30).
1 secondary outcome
Lysholm Knee Score
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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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 Knee Ligament Injury and PCL - Posterior Cruciate Ligament Rupture, run by Istituto Ortopedico Rizzoli 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 4 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: finished, as of the sponsor's last update on 25 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026.