Clinical trial NCT04649905: Psychological Response and Readiness Associated With OCD of the Knee
Official title: Psychological Response and Readiness to Return to Sports Associated With the Diagnosis and Treatment of Osteochondritis Dissecans of the Knee
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteochondritis Dissecans Knee
Psychological Stress
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Texas Scottish Rite Hospital for Children
First posted: 2020-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: THE CHILDREN'S IMPACT OF EVENT SCALE (CRIES-13) score
timeFrame: Time of surgical consultation/diagnosis for knee OCD
Secondary outcomes:
measure: THE CHILDREN'S IMPACT OF EVENT SCALE (CRIES-13) score
timeFrame: 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)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences
timeFrame: 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)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Symptoms
timeFrame: 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)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms
timeFrame: 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)
measure: ACL-Return to Sports after Injury (ACL-RSI)
timeFrame: 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)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Frisco
country: United States
facility: Texas Scottish Rite Hospital
state: Texas
Study officials:
affiliation: Boston Children's Hospital
name: Matthew D Milewski, MD
role: PRINCIPAL_INVESTIGATOR
References: