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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Hand Service, Department of Orthopaedic Surgery, Massachusetts General Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Disability with use of Quick DASH
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Satisfaction
時間枠: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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協力者と研究者
捜査官
- 主任研究者:David Ring, MD、Massachusetts General Hospital
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2012P000632
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