Psychological Response and Readiness Associated With OCD of the Knee

NCT04649905 | Active Not Recruiting

• 1 other identifier: IRB-P00036878
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteochondritis Dissecans Knee; Psychological Stress

Outcome Measures

Primary Outcomes (1)

• 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.

  Time of surgical consultation/diagnosis for knee OCD

Secondary Outcomes (5)

• THE CHILDREN'S IMPACT OF EVENT SCALE (CRIES-13) score

  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

  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

  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

  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)

  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)

Study Arms (2)

Surgical Treatment

Patient's in this cohort will undergo surgical treatment for OCD of the knee.

Procedure: Surgical Treatment

Nonoperative Treatment

Patient's in this cohort will undergo nonoperative treatment for OCD of the knee.

Procedure: Nonoperative Treatment

Interventions

Surgical Treatment PROCEDURE

Surgical standard-of-care treatment for knee OCD

Surgical Treatment

Nonoperative Treatment PROCEDURE

Nonoperative standard-of-care treatment for knee OCD

Nonoperative Treatment

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Between the ages 11-19
• Diagnosis of knee OCD confirmed by X-ray or MRI

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Texas Scottish Rite Hospital for Children: collaborator

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Texas Scottish Rite Hospital

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Matthew D Milewski, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedic Surgery, Harvard Medical School

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 2, 2020
• Study Start: January 4, 2021
• Primary Completion: January 12, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)