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Active, Not Recruiting

NCT Number: NCT04649905

Psychological Response and Readiness Associated With OCD 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

11 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgical treatment

Procedure

Surgical standard-of-care treatment for knee OCD

Nonoperative Treatment

Procedure

Nonoperative standard-of-care treatment for knee OCD

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Texas Scottish Rite Hospital for Children

Registry information

Official study title

Psychological Response and Readiness to Return to Sports Associated With the Diagnosis and Treatment of Osteochondritis Dissecans of the Knee

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Dec 2, 2020
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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