Clinical trial NCT04250415: Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment
Official title: Prospective, Multi-Center Adolescent Clavicle Fracture Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Clavicle Fracture
Keywords: Adolescent
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Rady Children's Hospital, San Diego
name: University of Michigan
name: Texas Scottish Rite Hospital for Children
name: Washington University School of Medicine
name: Campbell Clinic
name: University of California, San Francisco
name: Children's Healthcare of Atlanta
First posted: 2020-01-31
Enrollment: 250
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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 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

Primary outcomes:
measure: Changes in functional score from time of injury (or from time of surgery) using the American Shoulder and Elbow Surgeons score (ASES)
timeFrame: 2 years
Secondary outcomes:
measure: 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).
timeFrame: 2 years
measure: Changes in Activity Level from time of injury (or from time of surgery) using the Marx Shoulder Activity Scale.
timeFrame: 2 years
measure: Patient Quality of Life after injury (or surgery) using the EQ-5D-3L.
timeFrame: 2 years
measure: Patient Quality of Life after injury (or surgery) using the EQ-VAS.
timeFrame: 2 years
measure: Patient Satisfaction with treatment outcome after injury (or surgery)
timeFrame: 2 years
measure: Patient Return-to-Sport after injury (or surgery)
timeFrame: 2 years
Other outcomes:
Locations:
city: Oakland
country: United States
facility: University of California San Francisco Benioff Children's Hospital Oakland
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: Memphis
country: United States
facility: Campbell Clinic Orthopaedics
state: Tennessee
city: Dallas
country: United States
facility: Texas Scottish Rite Hospital
state: Texas
Study officials:
affiliation: Boston Children's Hospital
name: Benton E Heyworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heyworth BE, Pennock AT, Li Y, Liotta ES, Dragonetti B, Williams D, Ellis HB, Nepple JJ, Spence D, Willimon SC, Perkins CA, Pandya NK, Kocher MS, Edmonds EW, Wilson PL, Busch MT, Sabatini CS, Farley F, Bae DS. Two-Year Functional Outcomes of Operative vs Nonoperative Treatment of Completely Displaced Midshaft Clavicle Fractures in Adolescents: Results From the Prospective Multicenter FACTS Study Group. Am J Sports Med. 2022 Sep;50(11):3045-3055. doi: 10.1177/03635465221114420. Epub 2022 Aug 19.