- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01583556
Optional Follow-up Visits for Common, Low-risk Arm Fractures
Many common arm fractures have an excellent prognosis with little more than symptomatic treatment. When studying these fractures, investigators find that a substantial number of patients do not attend follow-up appointments. The difficulty of maneuvering in big cities, the cost of parking, the co-pay for the visit and the wait times for x-ray and doctor are all inconveniences that some patients might prefer to avoid. Building on prior research, it is appropriate to offer patients with common minor upper extremity fractures that have an excellent prognosis optional follow-up after the first visit. The plan would be to be available by phone, email and subsequent appointment at the patient's discretion if they felt that the recovery was off course. Benefit to individual participants is unlikely. The study will benefit the society as a whole, by providing a better understanding of these common fractures. It can also affect the economics of our health system by avoiding further follow-up appointments.
Primary null hypothesis: There is no difference in patient outcome 2-6 months after injury between patients that return for a second visit, and patients that do not.
Secondary null hypothesis: There is no difference in patient satisfaction 2-6 months after injury between patients that return for a second visit, and patients that do not.
Panoramica dello studio
Stato
Descrizione dettagliata
This study will employ a prospective, non-randomized design. After the questionnaires are filled the patients choose whether or not to schedule a second appointment for evaluation of their fracture: The first group will be scheduled for a second visit (standard treatment). The alternative (Optional follow-up) will be to take a handout describing the recovery and providing instructions for how to contact us should they get off course.
Since it is up to the subject to decide whether or not he or she wants a second appointment or the brochure, it is observational rather than interventional.
Evaluation: 2-6 months after injury all patients (independent of group) will be contacted by either phone or email by a blinded research assistant and asked to provide the following: pain with NRS (scale 0-10); three satisfaction questions; disability with use of Quick DASH; and if they returned to modified and regular work.
Patients in the standard group A will return to the Hand and Upper Extremity Service for their usual practice follow-up examination 1-3 months after treatment.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Hand Service, Department of Orthopaedic Surgery, Massachusetts General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- adult (>18 years)
- English-speaking
- fracture with an excellent prognosis such as:
- nondisplaced mallet fracture
- stable, well-aligned metacarpal fracture
- all small finger metacarpal neck fractures
- non- or minimally displaced distal radius fracture treated in a removable splint
- isolated minimally displaced radial head fracture involving the radial neck or part of the articular surface
Exclusion Criteria:
- pregnant women
- no written informed consent
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Standard treatment
This study will employ a prospective, non-randomized design.
After the questionnaires are filled the patients choose whether or not to schedule a second appointment for evaluation of their fracture: The first group will be scheduled for a second visit (standard treatment) as our daily practice after 1-3 months.
They will be contacted after 2-6 months either by phone or email and will complete again some questionnaires (Quick DASH, satisfaction, return to work).
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Optional follow-up group
The alternative (Optional follow-up group) will be to take a handout describing the recovery and providing instructions for how to contact us should they get off course.
The questionnaires will be repeated either by phone or email in 2-6 months.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Disability with use of Quick DASH
Lasso di tempo: Change from baseline at enrollment to follow-up at 2-6 months
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The Disabilities of Arm Shoulder and Hand (DASH) questionnaire is used frequently in hand and upper extremity research to assess disability. The Quick DASH is the short version of the DASH consisting of 11 questions. http://www.dash.iwh.on.ca/system/files/quickdash_questionnaire_2010.pdf |
Change from baseline at enrollment to follow-up at 2-6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Satisfaction
Lasso di tempo: Change from baseline at enrollment to follow-up at 2-6 months
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The investigators measure the overall current patient satisfaction with an ordinal scale from 0 to 10, 0 being completely dissatisfied, 10 being completely satisfied.
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Change from baseline at enrollment to follow-up at 2-6 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: David Ring, MD, Massachusetts General Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- Poolman RW, Goslings JC, Lee JB, Statius Muller M, Steller EP, Struijs PA. Conservative treatment for closed fifth (small finger) metacarpal neck fractures. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003210. doi: 10.1002/14651858.CD003210.pub3.
- Pike JM, Athwal GS, Faber KJ, King GJ. Radial head fractures--an update. J Hand Surg Am. 2009 Mar;34(3):557-65. doi: 10.1016/j.jhsa.2008.12.024.
- ten Berg PW, Ring D. Patients lost to follow-up after metacarpal fractures. J Hand Surg Am. 2012 Jan;37(1):42-6. doi: 10.1016/j.jhsa.2011.08.003. Epub 2011 Oct 19.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2012P000632
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