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Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment (FACTS)

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ClinicalTrials.gov Identifier: NCT04250415
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Rady Children's Hospital, San Diego
University of Michigan
Texas Scottish Rite Hospital for Children
Washington University School of Medicine
Campbell Clinic
University of California, San Francisco
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Benton Heyworth, Boston Children's Hospital

Brief Summary:
Investigators from eight tertiary care, level 1 pediatric trauma centers have developed a protocol for the establishment of a formal, prospective multi-center adolescent clavicle registry, with designs for standardized radiographic assessment and the prospective collection of validated outcome measures and complications data, for all patients, ages 10-18, treated for clavicle shaft fractures, operatively and non-operatively. Eventually, the investigators would like to do comparative analysis for the operative and non-operative treatment arms, with additional sub-stratified analyses performed within these treatment arms by age and activity level. Among the primary goals of research projects stemming from the first arm of this registry, FACTS A, is to explore the hypothesis that non-operative treatment is associated with lower costs, greater safety, and equivalent or superior outcomes, compared with operative treatment, despite a national trend towards increasing surgical treatment. The second arm of the registry, FACTS B, will continue to investigate the same hypotheses, excluding cost outcomes, in patients only with completely displaced midshaft clavicle fractures.

Condition or disease Intervention/treatment
Clavicle Fracture Procedure: Surgery

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prospective, Multi-Center Adolescent Clavicle Fracture Registry
Actual Study Start Date : March 11, 2013
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
Operative Arm Procedure: Surgery
Non-operative Arm



Primary Outcome Measures :
  1. Changes in functional score from time of injury (or from time of surgery) using the American Shoulder and Elbow Surgeons score (ASES) [ Time Frame: 2 years ]

    Patient-reported function over time will be assessed using the American Shoulder and Elbow Surgeons score (ASES).

    The ASES is a composite instrument comprised of two sections, including patient self-reported pain (7 items) and patient self-reported activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.



Secondary Outcome Measures :
  1. Changes in functional score from time of injury (or from time of surgery) using the Disabilities of the Arm, Shoulder, and Hand Score (Quick-DASH). [ Time Frame: 2 years ]

    Patient reported function over time will be assessed using the Disabilities of the Arm, Shoulder, and Hand Score (Quick-DASH).

    The QuickDASH questionnaire evaluates presence and degree of symptoms as well as perceived ability to perform functional tasks with the injured upper extremity. There are 5 responses for each question, graded on a scale from '1' to '5'. A response of '1' reflects the patient's perception to have either 'no symptoms', no limitations, or no perceived disability to the question prompt. A response of '5' reflects the patient's perception to have either 'extreme' symptoms, or inability to perform the task prompted in the question.


  2. Changes in Activity Level from time of injury (or from time of surgery) using the Marx Shoulder Activity Scale. [ Time Frame: 2 years ]

    Patient-reported activity level over time will be assessed using the Marx Shoulder Activity Scale.

    This questionnaire rates the frequency for which a patient is able to perform five functional activities with the injured upper extremity. Each prompt is rated on a five-point frequency scale from 'never performed' (0 points) to 'daily' (4 points). Two additional questions regarding ability to participate in sports generally considered 'contact sports' and ability to participate in sports involving 'overhead throwing' are rated on a scaled from 'No' (0 points) to 'Yes, on a professional level' (3 points). A higher cumulative score is reflective of 'better' function.


  3. Patient Quality of Life after injury (or surgery) using the EQ-5D-3L. [ Time Frame: 2 years ]
    Patient reported quality of life will be assessed through distribution of the EQ-5D-3L questionnaire. The EQ-5D-3L questionnaire is comprised from 5 dimensions including: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Responses are scored on an algorithm in which a higher number is indicative of a greater quality of life.

  4. Patient Quality of Life after injury (or surgery) using the EQ-VAS. [ Time Frame: 2 years ]
    Patient reported quality of life will be assessed through distribution of the EQ-VAS questionnaire. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state' ranging from the numerical value of '100' ('Best imaginable health state') to '0' ('Worst imaginable health state'). The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

  5. Patient Satisfaction with treatment outcome after injury (or surgery) [ Time Frame: 2 years ]

    Patients will be asked a series of 'yes-no' questions as well as questions related to their clinical progression since time of treatment for which responses range from 'completely satisfied' to 'completely unsatisfied'. If a patient underwent internal fixation with implanted hardware, the patient will be asked whether or not the hardware is bothersome.

    The rate of choice selection for each response, per question, will be cumulatively assessed.


  6. Patient Return-to-Sport after injury (or surgery) [ Time Frame: 2 years ]

    Patients will be asked their ability to return to sporting activities and level of competition compared to before their clavicle injury. Self-reported athletes will be further queried as to what sport/s they returned to, and whether they returned to the same level of competition. If athletes have not returned to play, or have returned at a less competitive level, they will be asked whether the change in sport participation or sport intensity was related to the clavicle injury, or due to other circumstances.

    The rate of choice selection for each response, per question, will be cumulatively assessed.




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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Males and females between the ages of 10 and 18, who visit Boston Children's Hospital or one of the other participating institutions for treatment of a primary, completely displaced mid-shaft clavicle fracture.
Criteria

Inclusion Criteria:

  • Aged 10-18
  • Diagnosis of a primary diaphyseal clavicle fracture
  • Fracture must be completely displaced
  • Patient - BCH subjects must pursue follow-up at BCH main campus or Walthammust be 59 days or less from the primary fracture
  • All study patients (across all sites) must agree to be contacted by a long-term follow-up coordinator based out of Boston Children's Hospital for long-term follow-up questions (out to the 2-year time point). This can/will be done via phone, mail, text message, and/or email.

Exclusion Criteria:

  • Pathological fracture
  • Previous ipsilateral fracture
  • Unable to fill out outcome collection forms
  • Refusal to participate
  • Underlying neurologic or neurocognitive disorder that affects UE function
  • Underlying metabolic bone disorder (e.g. osteogenesis imperfecta) that significantly alters normal bone healing
  • Unable to project injury X-ray films if treated initially at an institution that is not a member of this register

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250415


Contacts
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Contact: Elizabeth Liotta, MBBS Elizabeth.Liotta@childrens.harvard.edu
Contact: Lauren Hutchinson, MPH Lauren.Hutchinson@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lauren Hutchinson, MPH       Lauren.Hutchinson@childrens.harvard.edu   
Principal Investigator: Benton E Heyworth, MD         
Sub-Investigator: Mininder S Kocher, MD, MPH         
Sub-Investigator: Donald S Bae, MD         
Sponsors and Collaborators
Boston Children's Hospital
Rady Children's Hospital, San Diego
University of Michigan
Texas Scottish Rite Hospital for Children
Washington University School of Medicine
Campbell Clinic
University of California, San Francisco
Children's Healthcare of Atlanta
Investigators
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Principal Investigator: Benton E Heyworth, MD Boston Children's Hospital
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Responsible Party: Benton Heyworth, Principal Investigator, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04250415    
Other Study ID Numbers: IRB-P00004816
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benton Heyworth, Boston Children's Hospital:
Adolescent
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries