Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment (FACTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04250415|
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : October 7, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Clavicle Fracture||Procedure: Surgery|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||250 participants|
|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|
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||10 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250415
|Contact: Lauren Hutchinson, MPH||Lauren.Hutchinson@childrens.harvard.edu|
|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 firstname.lastname@example.org|
|Principal Investigator: Ying Li, MD|
|United States, Missouri|
|Washington University at St. Louis||Recruiting|
|Saint Louis, Missouri, United States|
|Contact: Julia Brown email@example.com|
|Principal Investigator: Jeffrey Nepple, MD|
|United States, Tennessee|
|Campbell Clinic Orthopaedics||Recruiting|
|Memphis, Tennessee, United States|
|Contact: Karen Romer firstname.lastname@example.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|
|Principal Investigator:||Benton E Heyworth, MD||Boston Children's Hospital|
|Responsible Party:||Benton Heyworth, Principal Investigator, Boston Children's Hospital|
|Other Study ID Numbers:||
|First Posted:||January 31, 2020 Key Record Dates|
|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|
Wounds and Injuries