Osteochondritis Dissecans KneeNCT04649905
Psychological Response and Readiness Associated With OCD of the Knee
An observational study of Osteochondritis Dissecans Knee and Psychological Stress, run by Boston Children's Hospital at 2 sites in United States.
Trial summary
This study primarily aims to determine whether patients diagnosed with osteochondritis dissecans (OCD) of the knee experience psychological stress due to their diagnosis and treatment plan. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Osteochondritis Dissecans Knee, Psychological Stress
- What is being tested?
- Surgical Treatment and Nonoperative Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jan 2021to 31 Dec 2026
- 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 11 to 19 years
- All sexes
- Child, Adult
Study population: Patients who meet eligibility criteria presenting to either 1) Boston Children's Sports Medicine and seen by Dr. Matthew Milewski, MD, or Dr. Melissa Christino, MD, with a new diagnosis of an OCD lesion of the knee; or 2) Texas Scottish Rite Hospital's Sports Medicine Clinic and seen by Dr. Henry Ellis, MD, or Dr. Philip Wilson, MD.
Who may be able to join
- Between the ages 11-19
- Diagnosis of knee OCD confirmed by X-ray or MRI
Who cannot join
- Had previous surgical treatment for their knee OCD lesion
- Received knee OCD non-operative treatment on the ipsilateral side for >6 months and taken out of sports/physical activities
- Guardian not comfortable with child completing survey
- Is not fluent in English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Texas Scottish Rite Hospital
Frisco, Texas, 75034
About this study
Official title: Psychological Response and Readiness to Return to Sports Associated With the Diagnosis and Treatment of Osteochondritis Dissecans of the Knee
This study primarily aims to determine whether patients diagnosed with osteochondritis dissecans (OCD) of the knee experience psychological stress due to their diagnosis and treatment plan. Secondarily, this study aims to determine whether knee OCD patients experience a change in stress and depression as they progress through their standard-of-care treatment plan, and whether they have impaired psychological readiness for return to sport.
Read the detailed description
Young athletes with poor psychological responses to injury and recovery may be at risk for suboptimal rehabilitation and return to sports. The issues of psychological readiness and fear/anxiety of reinjury are well documented in the treatment of ACL injuries in young athletes. To the investigative team's knowledge, no studies have examined the psychological response and psychological readiness to return to sports in pediatric and adolescent patients undergoing treatment for osteochondritis dissecans (OCD) of the knee.
OCD is a focal, idiopathic alteration of subchondral bone with risk for instability and disruption of adjacent articular cartilage that may result in premature osteoarthritis. It generally affects a young population between 6 and 19 years of age, with highest prevalence between the ages of 12 and 19 years of age. This condition can be treated both conservatively and surgically depending on the age of the patient, size of the lesion, severity and instability of the bone \& cartilage, and previous treatment. The unclear etiology of this condition, the delayed / prolonged pre-diagnosis symptoms, varied treatment options, and unpredictable healing timelines are all factors that families and patients find frustrating about this condition. The investigators of this study believe that this leads to higher than normal psychological stress at the time of diagnosis and throughout treatment of this condition.
Improved understanding of the psychological stress and readiness to return to sport in the treatment of knee OCD can help patients, their families, and clinicians alike. Awareness can help clinicians provide the appropriate outreach and counseling for patients at risk for increased psychological stress. Improved psychological states and readiness can improve both physical and mental well-being.
- Being tested
- Surgical Treatment, Nonoperative Treatment
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical TreatmentProcedure or surgery
Surgical standard-of-care treatment for knee OCD
Nonoperative TreatmentProcedure or surgery
Nonoperative standard-of-care treatment for knee OCD
| Study group | Role | What they receive |
|---|---|---|
| Surgical Treatment | Patient's in this cohort will undergo surgical treatment for OCD of the knee. Receives: Procedure: Surgical Treatment | |
| Nonoperative Treatment | Patient's in this cohort will undergo nonoperative treatment for OCD of the knee. Receives: Procedure: Nonoperative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
THE CHILDREN'S IMPACT OF EVENT SCALE (CRIES-13) score
A CRIES-13 score is a continuous number between 0 and 65 (the higher the score, the more severe the outcome). CRIES items will be keyed to the diagnosis and treatment of OCD (i.e., the patient is asked to indicate how frequently each comment was true for them during the past 7 days with respect to their experience with OCD).
The CRIES is a 13-item, 4-point scale assessing psychological distress. It has three subscales: intrusion, avoidance, and arousal. It is based off the Impact of Event Scale (IES) and is designed to address misinterpretation of items by children on the IES. It is designed for children 8 years of age and above to read independently. If the score is greater than or equal to 30, the score is indicative of increased subjective stress.
Measured: Time of surgical consultation/diagnosis for knee OCD
Secondary outcomes (5)
THE CHILDREN'S IMPACT OF EVENT SCALE (CRIES-13) score
A CRIES-13 score is a continuous number between 0 and 65 (the higher the score, the more severe the outcome). CRIES items will be keyed to the diagnosis and treatment of OCD (i.e., the patient is asked to indicate how frequently each comment was true for them during the past 7 days with respect to their experience with OCD).
The CRIES is a 13-item, 4-point scale assessing psychological distress. It has three subscales: intrusion, avoidance, and arousal. It is based off the Impact of Event Scale (IES) and is designed to address misinterpretation of items by children on the IES. It is designed for children 8 years of age and above to read independently. If the score is greater than or equal to 30, the score is indicative of increased subjective stress.
Measured: Scores taken repeatedly overtime between diagnosis and follow-up (at every clinic visit as well as 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis)
Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences
Assesses the thoughts or feelings about the world in the context of environmental or internal challenges. Patients will complete at the time of enrollment, any additional clinical visit, including 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis. There are 19 questions that are rated on a 1-5 scale. Overall, this outcome measure is scored 18-95 (lower score = less stress). Raw scores are then converted into T-scores. The investigators expect scores to increase during the early stages of treatment by at least 5 points (MCID) in the first 3 months and then decrease over time returning to baseline or above at 1- to 2-year follow up post diagnosis.
Measured: Scores taken repeatedly overtime between diagnosis and follow-up (at every clinic visit as well as 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis)
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Symptoms
This questionnaire assesses for anxiety in children and adolescents (ages 11-17). Patients will complete at the time of enrollment, any additional clinical visit, including 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis. There are 8 questions that are rated on a 1-5 scale. Overall, this outcome measure is scored 14-70 (higher score = greater severity in depression). Raw scores are then converted into T-scores. The investigators expect scores to increase during the early stages of treatment by at least 5 points (MCID) in the first 3 months and then decrease over time returning to baseline or above at 1- to 2-year follow up post diagnosis.
Measured: Scores taken repeatedly overtime between diagnosis and follow-up (at every clinic visit as well as 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis)
Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms
This questionnaire assesses for depression in children and adolescents (ages 11-17). Patients will complete at the time of enrollment, any additional clinical visit, including 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis. There are 8 questions that are rated on a 1-5 scale. Overall, this outcome measure is scored 14-70 (higher score = greater severity in depression). Raw scores are then converted into T-scores.
Measured: Scores taken repeatedly overtime between diagnosis and follow-up (at every clinic visit as well as 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis)
ACL-Return to Sports after Injury (ACL-RSI)
Questionnaire used to measure the psychological impact of returning to sport after ACL reconstruction surgery. Patients will complete this questionnaire at the clinic visit when they are cleared to RTS, 1 year and 2 years post diagnosis. There are 12 questions that are rated on a 0-10 scale. Overall, this outcome measure is scored 0-100 (higher score = more psychologically ready to RTS). A score greater than or equal to 77% indicates that the patient is psychologically ready to RTS.
Measured: Scores taken repeatedly overtime between diagnosis and follow-up (at every clinic visit as well as 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start4 Jan 2021
- Primary completion12 Jan 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondritis Dissecans KneeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Scottish Rite Hospital for Children
- Responsible party
- Principal investigator, Matthew Milewski, Boston Children's Hospital
- Investigators
- Matthew D Milewski, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649905
- Sponsor's protocol ID
- IRB-P00036878
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2020
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Response and Readiness to Return to Sports Associated With the Diagnosis and Treatment of Osteochondritis Dissecans of the Knee
- ClinicalTrials.gov ID
- NCT04649905
- Acronym / sponsor ID
- IRB-P00036878
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Texas Scottish Rite Hospital for Children
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Dec 2020 (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.
This study primarily aims to determine whether patients diagnosed with osteochondritis dissecans (OCD) of the knee experience psychological stress due to their diagnosis and treatment plan. Secondarily, this study aims to determine whether knee OCD patients experience a change in stress and depression as they progress through their standard-of-care treatment plan, and whether they have impaired psychological readiness for return to sport.
Detailed description
Young athletes with poor psychological responses to injury and recovery may be at risk for suboptimal rehabilitation and return to sports. The issues of psychological readiness and fear/anxiety of reinjury are well documented in the treatment of ACL injuries in young athletes. To the investigative team's knowledge, no studies have examined the psychological response and psychological readiness to return to sports in pediatric and adolescent patients undergoing treatment for osteochondritis dissecans (OCD) of the knee.
OCD is a focal, idiopathic alteration of subchondral bone with risk for instability and disruption of adjacent articular cartilage that may result in premature osteoarthritis. It generally affects a young population between 6 and 19 years of age, with highest prevalence between the ages of 12 and 19 years of age. This condition can be treated both conservatively and surgically depending on the age of the patient, size of the lesion, severity and instability of the bone \& cartilage, and previous treatment. The unclear etiology of this condition, the delayed / prolonged pre-diagnosis symptoms, varied treatment options, and unpredictable healing timelines are all factors that families and patients find frustrating about this condition. The investigators of this study believe that this leads to higher than normal psychological stress at the time of diagnosis and throughout treatment of this condition.
Improved understanding of the psychological stress and readiness to return to sport in the treatment of knee OCD can help patients, their families, and clinicians alike. Awareness can help clinicians provide the appropriate outreach and counseling for patients at risk for increased psychological stress. Improved psychological states and readiness can improve both physical and mental well-being.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Treatment | – | Procedure: Surgical TreatmentPatient's in this cohort will undergo surgical treatment for OCD of the knee. |
| Nonoperative Treatment | – | Procedure: Nonoperative TreatmentPatient's in this cohort will undergo nonoperative treatment for OCD of the knee. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients who meet eligibility criteria presenting to either 1) Boston Children's Sports Medicine and seen by Dr. Matthew Milewski, MD, or Dr. Melissa Christino, MD, with a new diagnosis of an OCD lesion of the knee; or 2) Texas Scottish Rite Hospital's Sports Medicine Clinic and seen by Dr. Henry Ellis, MD, or Dr. Philip Wilson, MD.
Key inclusion criteria (2 listed)
- Between the ages 11-19
- Diagnosis of knee OCD confirmed by X-ray or MRI
Key exclusion criteria (4 listed)
- Had previous surgical treatment for their knee OCD lesion
- Received knee OCD non-operative treatment on the ipsilateral side for >6 months and taken out of sports/physical activities
- Guardian not comfortable with child completing survey
- Is not fluent in English
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 |
|---|---|---|
| Surgical TreatmentSurgical standard-of-care treatment for knee OCD | Procedure or surgery | Surgical Treatment |
| Nonoperative TreatmentNonoperative standard-of-care treatment for knee OCD | Procedure or surgery | Nonoperative Treatment |
Primary outcome
THE CHILDREN'S IMPACT OF EVENT SCALE (CRIES-13) score
Time frame: Time of surgical consultation/diagnosis for knee OCD
A CRIES-13 score is a continuous number between 0 and 65 (the higher the score, the more severe the outcome). CRIES items will be keyed to the diagnosis and treatment of OCD (i.e., the patient is asked to indicate how frequently each comment was true for them during the past 7 days with respect to their experience with OCD). The CRIES is a 13-item, 4-point scale assessing psychological distress. It has three subscales: intrusion, avoidance, and arousal. It is based off the Impact of Event Scale (IES) and is designed to address misinterpretation of items by children on the IES. It is designed for children 8 years of age and above to read independently. If the score is greater than or equal to 30, the score is indicative of increased subjective stress.
5 secondary outcomes
THE CHILDREN'S IMPACT OF EVENT SCALE (CRIES-13) score
Time frame: Scores taken repeatedly overtime between diagnosis and follow-up (at every clinic visit as well as 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis)
Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences
Time frame: Scores taken repeatedly overtime between diagnosis and follow-up (at every clinic visit as well as 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis)
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Symptoms
Time frame: Scores taken repeatedly overtime between diagnosis and follow-up (at every clinic visit as well as 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis)
Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms
Time frame: Scores taken repeatedly overtime between diagnosis and follow-up (at every clinic visit as well as 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis)
ACL-Return to Sports after Injury (ACL-RSI)
Time frame: Scores taken repeatedly overtime between diagnosis and follow-up (at every clinic visit as well as 3 months, 6 months, 9 months, 1 year, and 2 years post diagnosis)
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 22 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Matthew D Milewski, MD principal investigator
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteochondritis Dissecans Knee and Psychological Stress, run by Boston Children's Hospital at 2 sites in United States.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
THE CHILDREN'S IMPACT OF EVENT SCALE (CRIES-13) score (time frame: Time of surgical consultation/diagnosis for knee OCD). 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 22 Apr 2026.