Evaluation of Clinical and Radiographic Outcomes of Surgically Treated Multiligamentous Knee Injuries

NCT ID: NCT06522659

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2026-02-28

Brief 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. 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.

Conditions

Knee Ligament Injury; PCL - Posterior Cruciate Ligament Rupture; PROMs

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

1. Patients aged between 18 and 65 years at the time of surgery

2. Male and female gender

3. Patients undergoing multiligamentous knee reconstruction from January 1, 2000, to December 31, 2019, at the Rizzoli Orthopedic Institute.

Exclusion Criteria

1. Patients no longer reachable;

2. Patients who do not consent to be included in the study;

3. Pregnant women;

4. Presence of infection or hematologic, rheumatic, or coagulative disorders at the time of evaluation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRRCS Rizzoli Ortopedic Institute

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

stefano zaffagnini

Role: CONTACT

stefano.zaffagnini@unibo.it

0516366075

Facility Contacts

Stefano Zaffagnini

Role: primary

stefano.zaffagnini@ior.it

0516366075

Other Identifiers

MULTI-LIG

Identifier Type: -

Identifier Source: org_study_id