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

NCT04250415 | Active Not Recruiting

• 1 other identifier: IRB-P00004816
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 8

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.

Conditions

Clavicle Fracture

Keywords

Adolescent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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).

  2 years

• Changes in Activity Level from time of injury (or from time of surgery) using the Marx Shoulder Activity Scale.

  2 years

• Patient Quality of Life after injury (or surgery) using the EQ-5D-3L.

  2 years

• Patient Quality of Life after injury (or surgery) using the EQ-VAS.

  2 years

• Patient Satisfaction with treatment outcome after injury (or surgery)

  2 years

Study Arms (2)

Operative Arm

Procedure: Surgery

Non-operative Arm

Interventions

Surgery PROCEDURE

Operative Arm

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Rady Children's Hospital, San Diego: collaborator
• University of Michigan: collaborator
• Texas Scottish Rite Hospital for Children: collaborator
• Washington University School of Medicine: collaborator
• Campbell Clinic: collaborator
• University of California, San Francisco: collaborator
• Children's Healthcare of Atlanta: collaborator

Study Sites (8)

University of California San Francisco Benioff Children's Hospital Oakland

Oakland, California, United States

Location

Rady Children's Hospital

San Diego, California, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Location

Washington University at St. Louis

St Louis, Missouri, United States

Location

Campbell Clinic Orthopaedics

Memphis, Tennessee, United States

Location

Texas Scottish Rite Hospital

Dallas, Texas, United States

Location

Related Publications (1)

• 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.

  PMID: 35984091 DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Benton E Heyworth, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 31, 2020
• Study Start: March 11, 2013
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (8)