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

Recruiting

• Conditions: PROMs; PCL - Posterior Cruciate Ligament Rupture; Knee Ligament Injury

• Registration Number: NCT06522659
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee (IKDC)	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).

Secondary Outcome Measures

Name	Time	Method
Lysholm Knee Score	5 years	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).

Trial Locations

Locations (1)

IRRCS Rizzoli Ortopedic Institute; 🇮🇹 Bologna, Italy