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

NCT06522659 | Completed DMC

• 1 other identifier: MULTI-LIG
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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; PROMs; PCL - Posterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• 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).

  5 years

Secondary Outcomes (1)

• Lysholm Knee Score

  5 years

Other Outcomes (6)

• Visual Analog Scale (VAS)

  5 years

• SF-36 (Short Form-36 Health Survey)

  5 years

• Tegner Score

  5 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRRCS Rizzoli Ortopedic Institute

Bologna, 40136, Italy

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 26, 2024
• Study Start: March 31, 2021
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

IT (1)