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.
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
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.
- Conditions
- Clavicle Fracture
- 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 group | Role | What they receive |
|---|---|---|
| Operative Arm | Not described Receives: Procedure: Surgery | |
| Non-operative Arm | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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.
- First posted31 Jan 2020
- Study start11 Mar 2013
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Benton Heyworth, Boston Children's Hospital
- Investigators
- Benton E Heyworth, MD, Principal investigator, Boston Children's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Adolescent Clavicle Fracture Registry
- ClinicalTrials.gov ID
- NCT04250415
- Acronym / sponsor ID
- FACTS / IRB-P00004816
- Conditions
- Clavicle Fracture
- Keywords
- Adolescent
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- 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
- Study start
- 11 Mar 2013 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative Arm | – | Procedure: Surgery |
| Non-operative Arm | – | – |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Pathological fracture
- Previous ipsilateral fracture
- Unable to fill out outcome collection forms
- Refusal to participate
- Underlying neurologic or neurocognitive disorder that affects UE function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery | Procedure or surgery | Operative Arm |
Primary outcome
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.
6 secondary outcomes
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
Changes in Activity Level from time of injury (or from time of surgery) using the Marx Shoulder Activity Scale.
Time frame: 2 years
Patient Quality of Life after injury (or surgery) using the EQ-5D-3L.
Time frame: 2 years
Patient Quality of Life after injury (or surgery) using the EQ-VAS.
Time frame: 2 years
Patient Satisfaction with treatment outcome after injury (or surgery)
Time frame: 2 years
Patient Return-to-Sport after injury (or surgery)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Derived from this study: PubMed 35984091Heyworth 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.
- Individual participant dataSharing planned: Undecided
Related trials for Clavicle Fracture
Recruiting
Fluoroscopic Endobutton in Clavicle Fractures and AC Dislocations
Clavicle Fracture
Active, not recruiting
Effectiveness of Superficial Cervical and Clavipectoral Block for Clavicle Surgery
Clavicle Fracture, Postoperative Pain
Enrolling by invitation
Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)
Clavicle Surgery, Clavicle Fracture
Active, not recruiting
KT Tape for Pediatric Clavicle Fractures
Clavicle Fracture
Active, not recruitingObservational study
Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes
Pseudarthrosis, Clavicle Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benton E Heyworth, MD principal investigator
Boston Children's Hospital
8 sites in 1 country: see every site and its status.
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.