- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04649905
Psychological Response and Readiness Associated With OCD of the Knee
Psychological Response and Readiness to Return to Sports Associated With the Diagnosis and Treatment of Osteochondritis Dissecans of the Knee
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lauren E Hutchinson, MPH
- Phone Number: 91632 (617) 919-1632
- Email: Lauren.Hutchinson@childrens.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
-
Contact:
- Lauren E Hutchinson
- Phone Number: 617-919-1632
- Email: Lauren.Hutchinson@childrens.harvard.edu
-
Principal Investigator:
- Matthew D Milewski, MD
-
Sub-Investigator:
- Melissa A Christino, MD
-
-
Texas
-
Frisco, Texas, United States, 75034
- Recruiting
- Texas Scottish Rite Hospital
-
Contact:
- Savannah Cooper
- Email: Savannah.Cooper@tsrh.org
-
Principal Investigator:
- Henry B Ellis, MD
-
Sub-Investigator:
- Philip L Wilson, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between the ages 11-19
- Diagnosis of knee OCD confirmed by X-ray or MRI
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgical Treatment
Patient's in this cohort will undergo surgical treatment for OCD of the knee.
|
Surgical standard-of-care treatment for knee OCD
|
Nonoperative Treatment
Patient's in this cohort will undergo nonoperative treatment for OCD of the knee.
|
Nonoperative standard-of-care treatment for knee OCD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Time of surgical consultation/diagnosis for knee OCD
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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. |
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew D Milewski, MD, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00036878
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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