Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint

Osteochondritis Dissecans Clinical Trial

— OC-FIX  

Official title:

Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462040
• Other study ID #: OC-FIX
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 1, 2028

Study information

• Verified date: June 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Stefano Zaffagnini
• Phone: 0516366075
• Email: stefano.zaffagnini[@]ior.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Various techniques for the fixation of unstable osteochondral fragments have been used over the years, each with associated advantages and disadvantages, and differing clinical outcomes. However, the literature on the treatment of this type of injury in the adolescent and young adult population is scarce and involves small case series. Failure to treat these injuries can lead to serious consequences such as chronic pain, residual joint stiffness, and the development of early osteoarthritis, necessitating more invasive and burdensome interventions for the national health system, such as prosthetic replacements or osteotomies.

Due to the lack of real consensus within the scientific community regarding the ideal treatment for these patients and the insufficient medium/long-term follow-up data on the effects of these injuries on articular cartilage in young patients, this study aims to evaluate the clinical and radiological conditions of patients undergoing osteochondral fragment fixation using the same surgical technique (fixation with resorbable screws performed arthroscopically or via open surgery depending on the lesion's location) in order to clarify preventive measures against cartilage degeneration following these injuries, which are very common in adolescence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2028
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Patients undergoing surgical fixation of osteochondral fragment using resorbable screw technique, either arthroscopically or via mini-open procedure depending on the lesion's location, from 01/01/2017, and all new patients eligible for this type of intervention until 31/12/2025.

2. Patients aged between 12 and 35 years at the time of the surgical intervention.

3. Patients with the presence of osteochondral fragments confirmed by magnetic resonance imaging.

4. Patients with osteochondral lesions observed on imaging and symptoms attributable to the presence of osteochondral fragments.

5. Patients diagnosed with osteochondritis dissecans or recent contusion/sprain trauma.

Exclusion Criteria:

1. Patients with concomitant complex ligamentous injuries or fractures at the time of the intervention;

2. Patients who are no longer reachable;

3. Women of childbearing age who cannot exclude pregnancy;

4. Patients who are unable to provide informed consent or patients who are unwilling to sign the informed consent form.

Related Conditions & MeSH terms

• Fractures, Bone
• Osteochondral Defect
• Osteochondritis
• Osteochondritis Dissecans
• Patella Fracture

Intervention

Procedure:
• Fixation of osteochdral fragments with reabsorbable screws
Arthroscopic or mini-open fixation of free-intrarticular or unstable osteochondral fragments due to osteochondritis dissecans or osteochondral fractures with reabsorbable screws

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KOOS (Knee Injury and Ostearthritis Outcome Score) score	It represents a subjective score composed of 42 questions divided into 5 main domains. These domains investigate various aspects of symptoms and daily activities as well as the quality of life related to the knee and are divided as follows: Symptoms, composed of 7 questions, 2 of which pertain to stiffness; Pain, composed of 9 questions; Functions and daily activities, composed of 17 questions; Sports and recreational activities, composed of 5 questions; Quality of life in relation to the knee, composed of 4 questions. All questions use the same response format, utilizing a quantitative scale ranging from 0 (no issues) to 4 (severe difficulty). Scores are calculated separately for each domain and converted into a percentage score, where 100 represents excellent physical condition with no symptoms and 0 represents severe disability with limitations in daily activities and constant symptoms even at rest.	At least 24 months after surgery
Secondary	Kujala Anterior Knee Pain Scale	The Kujala score is a subjective knee assessment tool that quantifies limitations in daily and sports activities, as well as the presence or absence of symptoms. The questionnaire consists of 13 multiple-choice questions, with a total score ranging from 0 to 100. Each question has a variable score from 5 to 10 points and includes 3, 4, or 5 multiple-choice answers. The topics covered by each question include limping, pain, swelling, flexion deficit, and difficulty performing various types of activities. The maximum score of 100 represents no limitations or symptoms; the further the score deviates from 100, the worse the outcome.	At least 24 months after surgery
Secondary	International Knee Documentation Committee (IKDC) Score	The IKDC score is a subjective knee assessment tool that assesses limitations in daily and sports activities, as well as the presence or absence of symptoms.; The IKDC score comprises three main domains: Symptoms, which include pain, stiffness, swelling, and the sensation of locking.; Sports and daily activities.; Current knee function and function before the injury.; The questionnaire consists of 10 questions: Seven items inquire about the patient's symptoms.; One item focuses on participation in sports.; One item, composed of 9 points, addresses the difficulties the patient experiences in performing daily activities.; The last item measures the current functionality of the knee.; Scores range from 0 to 100, where 100 represents the absence of limitations and symptoms. The further the score deviates from 100, the worse the outcome, which can be categorized into four groups: excellent (80-100), good (60-80), fair (30-60), and poor (0-30).	At least 24 months after surgery
Secondary	Objective IKDC (IKDC standard evaluation form)	This represents a clinical chart that is completed by the physician following a comprehensive knee examination where various clinical tests are performed to assess for any joint deformities, objective instability, and meniscal injuries. The score obtained determines an objective evaluation grade coded using letters. According to this scale, grade "A" is assigned to a knee with "normal functionality, as healthy," grade "B" is assigned to a knee with "almost normal functionality," grade "C" is assigned to a knee with "moderately abnormal functionality," and grade "D" is assigned to a knee with "severely abnormal functionality."	At least 24 months after surgery
Secondary	MARX Activity Rating Scale	The MARX questionnaire is a subjective assessment tool designed to evaluate the activity level of patients with knee disorders who engage in sports. It focuses on four domains of sports activity: running, deceleration, cutting, pivoting.; Patients are asked to approximate how many times they have performed each of these activities over the past twelve months. The four knee functions are evaluated on a 5-point frequency scale, and the scores are summed up to a maximum of sixteen points, where a higher score indicates more frequent participation and thus is correlated with a higher knee health status.; The MARX questionnaire differs from many other activity measures because it is not based on participation in specific sports activities. Instead, patients are asked about different components of physical function (such as running and pivoting) common to various sports. The aim of this tool is to identify the overall activity level of the patient rather than their most recent activity.	At least 24 months after surgery
Secondary	VAS (Visual Analog Scale) for pain	This is a quantitative, one-dimensional numeric pain assessment scale, ranging from 0 to 10. The scale requires the patient to select the number that best describes the intensity of their pain, from 0 to 10, at the time of the visit and before the surgical intervention. 0 indicates no pain, while 10 indicates the worst possible pain.	At least 24 months after surgery
Secondary	Radiological evaluation (MRI, magnetic resonance imaging) throughout ICRS Cartilage Score	Assessment of healing of the fragment fixation	24 months after surgery
Secondary	Radiological evaluation (MRI, magnetic resonance imaging) throughout Outerbridge Classification	Healing status of ostechondral fragment	24 months after surgery
Secondary	Sports Activity Level, Tegner Score	Allows estimation of a subject's motor activity level with a score ranging from 0 to 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as national or international-level soccer. This score is commonly used to define the motor activity level of patients with knee disorders. Additionally, patients will be asked how many years they have been active in sports and whether the reduction or cessation of activity is related to knee pathology or not.	At least 24 months after surgery
Secondary	Thigh circumference	Measuring the circumference of the thigh at 5 cm and 15 cm from the superior pole of the patella allows for the evaluation of the degree of muscle trophism of the subjects under examination, and thus the potential influence of the type of technique used on muscle trophism.	At least 24 months after surgery
Secondary	Anterior knee pain / pain during knee flexion	In order to specifically assess the symptoms of the patellofemoral joint, patients will be asked to respond to these questions dichotomously (YES/NO).	At least 24 months after surgery
Secondary	Likert scale	In order to assess the level of patient satisfaction, they will be asked to respond to a question composed of 5 levels of satisfaction (from 1 to 5), where 1 indicates that the patient is very satisfied with the intervention, while 5 indicates a high degree of dissatisfaction.	At least 24 months after surgery
Secondary	Complications, subsequent interventions, or surgical failures	Any complications, subsequent interventions, and surgical failures will be documented and recorded in the CRF.	At least 24 months after surgery