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Clavicle FractureFACTSNCT04250415

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

An observational study of Clavicle Fracture, run by Boston Children's Hospital at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Clavicle Fracture
What is being tested?
Surgery
Type of treatment
Surgery or procedure
How many people
250 participants
Where
8 sitesUnited States
Study dates
11 Mar 2013to 1 Jun 2027
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • Child, Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites
  • University of Michigan Medical Center

    Ann Arbor, Michigan

  • Children's Healthcare of Atlanta

    Atlanta, Georgia

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Texas Scottish Rite Hospital

    Dallas, Texas

  • Campbell Clinic Orthopaedics

    Memphis, Tennessee

  • University of California San Francisco Benioff Children's Hospital Oakland

    Oakland, California

  • Rady Children's Hospital

    San Diego, California

  • Washington University at St. Louis

    St Louis, Missouri

Other trials in United States

About this study

Official title: Prospective, Multi-Center Adolescent Clavicle Fracture Registry

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.

Being tested
Surgery
Keywords
Adolescent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

Study groups in NCT04250415
Study groupRoleWhat they receive
Operative ArmNot described
Receives: Procedure: Surgery
Non-operative ArmNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (6)
  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).

    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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. 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.

    Measured: 2 years

  5. 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.

    Measured: 2 years

  6. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2020
  2. Study start11 Mar 2013
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04250415
Sponsor's protocol ID
IRB-P00004816
Acronym
FACTS
Status last verified
Jun 2025
First submitted
23 Jan 2020
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35984091

Questions about this trial

What is this clinical trial studying?

An observational study of Clavicle Fracture, run by Boston Children's Hospital at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04250415, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

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