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Osteochondral DefectOC-FIXNCT06462040

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

An observational study of Osteochondral Defect and Osteochondritis Dissecans, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 12 to 35 years
What is being tested?
Fixation of osteochdral fragments with reabsorbable screws
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteItaly
Study dates
25 Sep 2024to Jun 2028
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 12 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Patients will be recruited from all subjects who have already undergone surgical treatment for fixation of knee osteochondral fragments using resorbable screws since 2017, and all new patients eligible for this type of intervention until 2025 at the Orthopedic and Traumatology Clinic II of the Rizzoli Orthopedic Institute.

Who may be able to join

  • 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.
  • Patients aged between 12 and 35 years at the time of the surgical intervention.
  • Patients with the presence of osteochondral fragments confirmed by magnetic resonance imaging.
  • Patients with osteochondral lesions observed on imaging and symptoms attributable to the presence of osteochondral fragments.
  • Patients diagnosed with osteochondritis dissecans or recent contusion/sprain trauma.

Who cannot join

  • Patients with concomitant complex ligamentous injuries or fractures at the time of the intervention;
  • Patients who are no longer reachable;
  • Women of childbearing age who cannot exclude pregnancy;
  • Patients who are unable to provide informed consent or patients who are unwilling to sign the informed consent form.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stefano Zaffagnini contact

0516366075

stefano.zaffagnini@ior.it

Italy1 site, 1 recruiting
  • IRCCS Rizzoli Orthopedic Institute

    Bologna, Bologna, 40136

    Stefano Zaffagnini, +39 0516366075, stefano.zaffagnini@ior.it

    Recruiting

Other trials in Italy

About this study

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.

Being tested
Fixation of osteochdral fragments with reabsorbable screws
Medical subject headings
Osteochondritis Dissecans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fixation of osteochdral fragments with reabsorbable screwsProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At least 24 months after surgery

Secondary outcomes (12)
  1. 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.

    Measured: At least 24 months after surgery

  2. 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:

    1. Symptoms, which include pain, stiffness, swelling, and the sensation of locking.
    2. Sports and daily activities.
    3. 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).

    Measured: At least 24 months after surgery

  3. 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."

    Measured: At least 24 months after surgery

  4. 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.

    Measured: At least 24 months after surgery

  5. 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.

    Measured: At least 24 months after surgery

  6. Radiological evaluation (MRI, magnetic resonance imaging) throughout ICRS Cartilage Score

    Assessment of healing of the fragment fixation

    Measured: 24 months after surgery

  7. Radiological evaluation (MRI, magnetic resonance imaging) throughout Outerbridge Classification

    Healing status of ostechondral fragment

    Measured: 24 months after surgery

  8. 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.

    Measured: At least 24 months after surgery

  9. 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.

    Measured: At least 24 months after surgery

  10. 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).

    Measured: At least 24 months after surgery

  11. 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.

    Measured: At least 24 months after surgery

  12. Complications, subsequent interventions, or surgical failures

    Any complications, subsequent interventions, and surgical failures will be documented and recorded in the CRF.

    Measured: At least 24 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2024
  2. Study start25 Sep 2024
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
Cohort
Time perspective
Other
Enrolment
100 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06462040
Sponsor's protocol ID
OC-FIX
Acronym
OC-FIX
Status last verified
Jan 2026
First submitted
11 Jun 2024
Last updated
30 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: In the first phase, specialized medical personnel will identify eligible subjects within the hospital database. For retrospective cohorts, patients with provided contact details will be contacted, ensuring their consent for research participation. Interested patients will schedule a follow-up visit, during which they\'ll receive informational material and provide informed consent. Patients undergoing revision surgery or with septic arthritis will be considered surgical failures and excluded from follow-up. In the second phase, patients, after signing consent, will undergo clinical evaluation at least 24 months post-surgery, focusing on subjective assessments and clinical-instrumental tests. Knee MRI will evaluate radiological healing, with MRIs performed if documentation is unavailable. Visits will occur at the research clinic, and data will be recorded in Case Report Forms. The data will be entered into the RedCap Database.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteochondral Defect and Osteochondritis Dissecans, 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 5 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: looking for participants now, as of the sponsor's last update on 30 Jan 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stefano Zaffagnini (0516366075, stefano.zaffagnini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KOOS (Knee Injury and Ostearthritis Outcome Score) score (time frame: At least 24 months after surgery). 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 30 Jan 2026.

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