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.
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
- Conditions the study is for
- Osteochondral Defect, Osteochondritis Dissecans, Osteochondral Fracture
- 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.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Rizzoli Orthopedic Institute
Bologna, Bologna, 40136
Stefano Zaffagnini, +39 0516366075, stefano.zaffagnini@ior.it
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.
- Conditions
- Osteochondral Defect, Osteochondritis Dissecans, Osteochondral Fracture, Osteochondral Fracture of Patella
- 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.
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)
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
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).
Measured: At least 24 months after surgery
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
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
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
Radiological evaluation (MRI, magnetic resonance imaging) throughout ICRS Cartilage Score
Assessment of healing of the fragment fixation
Measured: 24 months after surgery
Radiological evaluation (MRI, magnetic resonance imaging) throughout Outerbridge Classification
Healing status of ostechondral fragment
Measured: 24 months after surgery
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
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
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
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
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.
- First posted17 Jun 2024
- Study start25 Sep 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral DefectStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint
- ClinicalTrials.gov ID
- NCT06462040
- Acronym / sponsor ID
- OC-FIX / OC-FIX
- Conditions
- Osteochondral Defect, Osteochondritis Dissecans, Osteochondral Fracture, Osteochondral Fracture of Patella
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixation of osteochdral fragments with reabsorbable screwsArthroscopic or mini-open fixation of free-intrarticular or unstable osteochondral fragments due to osteochondritis dissecans or osteochondral fractures with reabsorbable screws | Procedure or surgery | – |
Primary outcome
KOOS (Knee Injury and Ostearthritis Outcome Score) score
Time frame: At least 24 months after surgery
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.
12 secondary outcomes
Kujala Anterior Knee Pain Scale
Time frame: At least 24 months after surgery
International Knee Documentation Committee (IKDC) Score
Time frame: At least 24 months after surgery
Objective IKDC (IKDC standard evaluation form)
Time frame: At least 24 months after surgery
MARX Activity Rating Scale
Time frame: At least 24 months after surgery
VAS (Visual Analog Scale) for pain
Time frame: At least 24 months after surgery
Radiological evaluation (MRI, magnetic resonance imaging) throughout ICRS Cartilage Score
Time frame: 24 months after surgery
Radiological evaluation (MRI, magnetic resonance imaging) throughout Outerbridge Classification
Time frame: 24 months after surgery
Sports Activity Level, Tegner Score
Time frame: At least 24 months after surgery
Thigh circumference
Time frame: At least 24 months after surgery
Anterior knee pain / pain during knee flexion
Time frame: At least 24 months after surgery
Likert scale
Time frame: At least 24 months after surgery
Complications, subsequent interventions, or surgical failures
Time frame: At least 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: 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.
Related trials for Osteochondral Defect
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
Enrolling by invitationPhase 3
A RCT of Collagen Scaffold for the Repair of Talus Cartilage Injury
Cartilage Defects, Talus Osteochondral Defect
Not yet recruiting
Biologic Augmentation of Osteochondral Allograft Transplantation in the Knee
Osteochondral Defect, Articular Cartilage Defect
Active, not recruiting
Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
Osteochondral Defect
Enrolling by invitationObservational study
Clinical Registry Assessment of the Missouri Osteochondral Allograft Preservation System - MOPS
Symptomatic Osteochondral Defect(s), Cartilage, Meniscus, Ankle, Knee, Shoulder, Hip
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.