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

Clavicle Fracture Clinical Trial

— FACTS  

Official title:

Prospective, Multi-Center Adolescent Clavicle Fracture Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04250415
• Other study ID #: IRB-P00004816
• Status: Recruiting
• Start date: March 11, 2013
• Est. completion date: June 1, 2026

Study information

• Verified date: September 2023
• Source: Boston Children's Hospital
• Contact: Lauren Hutchinson, MPH
• Email: Lauren.Hutchinson[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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 Waltham must 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

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

Procedure:
• Surgery

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Texas Scottish Rite Hospital	Dallas	Texas
United States	Campbell Clinic Orthopaedics	Memphis	Tennessee
United States	University of California San Francisco Benioff Children's Hospital Oakland	Oakland	California
United States	Washington University at St. Louis	Saint Louis	Missouri
United States	Rady Children's Hospital	San Diego	California

Sponsors (8)

Lead Sponsor	Collaborator
Boston Children's Hospital	Campbell Clinic, Children's Healthcare of Atlanta, Rady Children's Hospital, San Diego, Texas Scottish Rite Hospital for Children, University of California, San Francisco, University of Michigan, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in functional score from time of injury (or from time of surgery) using the American Shoulder and Elbow Surgeons score (ASES)	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.	2 years
Secondary	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).	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 years
Secondary	Changes in Activity Level from time of injury (or from time of surgery) using the Marx Shoulder Activity Scale.	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.	2 years
Secondary	Patient Quality of Life after injury (or surgery) using the EQ-5D-3L.	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.	2 years
Secondary	Patient Quality of Life after injury (or surgery) using the EQ-VAS.	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.	2 years
Secondary	Patient Satisfaction with treatment outcome after injury (or surgery)	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.	2 years
Secondary	Patient Return-to-Sport after injury (or surgery)	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.	2 years