跳至主要内容
临床试验/NCT04649905
NCT04649905进行中(未招募)不适用

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

Boston Children's Hospital4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
4
主要终点
THE CHILDREN'S IMPACT OF EVENT SCALE (CRIES-13) score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
11 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Surgical Treatment

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

干预措施: Surgical Treatment (Procedure)

Nonoperative Treatment

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

干预措施: Nonoperative Treatment (Procedure)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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) 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) 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) 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Milewski

Assistant Professor of Orthopedic Surgery, Harvard Medical School

Boston Children's Hospital

研究点 (4)

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