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

• ClinicalTrials.gov Identifier: NCT04250415
• Recruitment Status: Recruiting
• First Posted: January 31, 2020
• Last Update Posted: October 7, 2022
• Sponsor: Boston Children's Hospital
• 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
• Information provided by (Responsible Party): Benton Heyworth, Boston Children's Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Clavicle Fracture	Procedure: Surgery

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Official Title: Prospective, Multi-Center Adolescent Clavicle Fracture Registry
• Actual Study Start Date: March 11, 2013
• Estimated Primary Completion Date: June 1, 2023
• Estimated Study Completion Date: June 1, 2026

Groups and Cohorts

Group/Cohort	Intervention/treatment
Operative Arm	Procedure: Surgery
Non-operative Arm

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

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). [ Time Frame: 2 years ]

   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. Changes in Activity Level from time of injury (or from time of surgery) using the Marx Shoulder Activity Scale. [ Time Frame: 2 years ]

   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.

3. Patient Quality of Life after injury (or surgery) using the EQ-5D-3L. [ Time Frame: 2 years ]
   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.
4. Patient Quality of Life after injury (or surgery) using the EQ-VAS. [ Time Frame: 2 years ]
   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.
5. Patient Satisfaction with treatment outcome after injury (or surgery) [ Time Frame: 2 years ]

   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.

6. Patient Return-to-Sport after injury (or surgery) [ Time Frame: 2 years ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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.

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

Contacts and Locations

Contacts

Contact: Lauren Hutchinson, MPH; Lauren.Hutchinson@childrens.harvard.edu

Locations

United States, California

University of California San Francisco Benioff Children's Hospital Oakland; Recruiting

Oakland, California, United States

Contact: Toshali Katyal

Principal Investigator: Coleen Sabatini, MD

Sub-Investigator: Nirav Pandya, MD

Rady Children's Hospital; Recruiting

San Diego, California, United States

Contact: Alyssa Carroll ACarroll1@rchsd.org

Principal Investigator: Eric Edmonds, MD

Sub-Investigator: Andrew Pennock, MD

United States, Georgia

Children's Healthcare of Atlanta; Recruiting

Atlanta, Georgia, United States

Contact: Asahi Murata Asahi.Murata@choa.org

Principal Investigator: Clifton Willimon, MD

Sub-Investigator: Crystal Perkins, MD

Sub-Investigator: Michael Busch, MD

United States, Massachusetts

Boston Children's Hospital; Recruiting

Boston, Massachusetts, United States, 02115

Contact: Michael Quinn Michael.Quinn@childrens.harvard.edu

Contact: Becky Parmeter, MPH 781-216-3080 Becky.Parmeter@childrens.harvard.edu

Principal Investigator: Benton E Heyworth, MD

Sub-Investigator: Mininder S Kocher, MD, MPH

Sub-Investigator: Donald S Bae, MD

United States, Michigan

University of Michigan Medical Center; Recruiting

Ann Arbor, Michigan, United States

Contact: Grace Carey gecarey@med.umich.edu

Principal Investigator: Ying Li, MD

United States, Missouri

Washington University at St. Louis; Recruiting

Saint Louis, Missouri, United States

Contact: Julia Brown brown.julia@wustl.edu

Principal Investigator: Jeffrey Nepple, MD

United States, Tennessee

Campbell Clinic Orthopaedics; Recruiting

Memphis, Tennessee, United States

Contact: Karen Romer kromer@campbell-foundation.org

Principal Investigator: David Spence, MD

United States, Texas

Texas Scottish Rite Hospital; Recruiting

Dallas, Texas, United States

Contact: Connor Carpenter Connor.Carpenter@tsrh.org

Principal Investigator: Henry Ellis, MD

Sub-Investigator: Philip Wilson, MD

Sponsors and Collaborators

Boston Children's Hospital

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

Investigators

• Principal Investigator: Benton E Heyworth, MD; Boston Children's Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Benton Heyworth, Principal Investigator, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT04250415
• Other Study ID Numbers: IRB-P00004816
• First Posted: January 31, 2020
• Last Update Posted: October 7, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Benton Heyworth, Boston Children's Hospital:

Adolescent

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries