A Prospective Randomised Controlled Trial of Operative Versus Nonoperative Management of Fractures of the Humeral Diaphysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Disabilities of the Arm, Shoulder and Hand (DASH) score
研究概览
简要总结
Fractures of the humeral shaft (upper arm bone) account for approximately 1% of all adult fractures in the United Kingdom. Historically, these injuries have been treated using a cast and/or brace, with immediate surgical fixation reserved for severely- or multiply-injured patients. However, treatment with a brace is associated with several important problems, including poor alignment of the healed bones and shoulder/elbow stiffness. The brace is usually worn for up to 3 months, which interferes with patients' everyday activities and sleeping, and can predispose to skin problems. For 10-15% of patients treated with a brace, their fracture will not heal and will require surgery several months after the original injury, which is more difficult and carries a higher risk of complications. Recent studies suggest that undertaking immediate surgical fixation more often could improve healing and functional outcome for patients with humeral shaft fractures. The only published randomised controlled trial (RCT) to date showed no difference in clinical outcome between conservative and operative management; unfortunately, however, the operative technique used was unusual and would be considered highly suboptimal in most Western countries.
This study will include adult patients (≥16 years), with capacity to consent and complete post-operative questionnaires in English, presenting to a single Orthopaedic trauma unit. Participants will be randomised to either non-operative treatment (with a brace) or operative treatment (i.e. surgical fixation). The investigators will assess whether there is a difference between the groups in terms of patient-reported outcome scores, fracture healing, complications, pain and return to work/sport over a one-year follow-up period. Participants will be enrolled into the study after obtaining informed consent. Following randomisation (to either non-operative treatment or surgical fixation), participants will then be reviewed at several defined timepoints, with a combination of clinical examination, X-rays and patient-reported outcome scores. The investigators hope that study results will enable surgeons to make better-informed decisions when managing patients with humeral shaft fractures.
详细描述
This study will include patients presenting to a single centre - the Edinburgh Orthopaedic Trauma Unit, Royal Infirmary of Edinburgh - with an isolated fracture of the humeral shaft.
All patients will be treated in the Emergency Department (ED) with closed reduction and application of a U-slab or hanging cast, and then referred to the Orthopaedic service. This referral will occur just prior to discharge from the ED, and will either be immediate (via the on-call team, for example where the patient requires in-patient admission) or delayed (via the Trauma Triage Clinic system, in which patients are discharged home and subsequently given an outpatient appointment).
Patients will be considered for the study if the following initial criteria are met:
- The patient has sustained a fracture of the humeral shaft (defined as any fracture in which the major fracture line does not extend to within one metaphyseal width/'Müller box' of either the shoulder or elbow joint);
- The patient is aged 16 years or older;
- The patient is able to comply with post-operative data gathering, including attending local follow-up appointments and completing questionnaires in English.
Complete inclusion and exclusion criteria are provided in the 'Eligibility' section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
There is no blinding possible in this study, as the presence or absence of a skin incision/surgical scar is obvious to both patient and clinician during follow-up assessment.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fracture of the humeral shaft
- •Closed injury
- •Age ≥16 years
- •Able to provide informed consent in English
- •Surgery performed within 3 weeks of date of injury
排除标准
- •Completely undisplaced fractures
- •Injuries considered to be an absolute indication for surgery (including severe associated neurovascular injury, open fractures and bilateral injuries)
- •Patients with a periprosthetic or pathological fracture
- •Patients with an additional spine or limb injury (including those with polytrauma), which may impact upon functional rehabilitation
- •Patients medically unfit for surgery
- •Very frail patients (CSHA Clinical Frailty Score ≥6/9)
- •Pregnant women with predetermined treatment
- •Patients declining operative management
- •Patients unable to provide informed consent in English
- •Patients unable to comply with post-operative data gathering, including completing questionnaires in English
- •Non-residents, unable to return to the Unit for follow-up for a period of 1-year
- •Where the treating surgeon does not feel that inclusion in the trial is in the patient's best interests, either due to fracture pattern or patient factors
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand (DASH) score
时间窗: 3 months
The DASH score is a functional rating scale developed in 1996, which has been used extensively as a research tool in upper limb surgery. It consists of a 30-item self-reported questionnaire, and 2 optional modules assessing work and sports/performing arts. Patient symptoms (including pain, weakness, stiffness and tingling/numbness) and functional status (including physical, social and psychological aspects) during the week prior to survey completion are assessed. A final score is awarded from 0 to 100, with 0 representing no disability and 100 the worst possible disability. The DASH score at 3 months post-intervention will form the primary outcome measure.
次要结局
- Pain visual analogue scale (VAS)(2 weeks, 6 weeks, 3 months, 6 months, one year)
- Satisfaction with service visual analogue scale (VAS)(2 weeks, 6 weeks, 3 months, 6 months, one year)
- Treatment complications(2 weeks, 6 weeks, 3 months, 6 months, one year)
- Shoulder/elbow range of motion (measured in degrees)(6 weeks, 3 months, 6 months, one year)
- 12-item Short Form (SF-12) Health Survey score(6 weeks, 3 months, 6 months, one year)
- Change in Disabilities of the Arm, Shoulder and Hand (DASH) score(6 weeks, 3 months, 6 months, one year)
- Return to work/sport(6 weeks, 3 months, 6 months, one year)
- Radiographic assessment(6 weeks, 3 months, one year)
- EuroQol (EQ-5D) Health Outcome score(6 weeks, 3 months, 6 months, one year)
研究者
William Oliver
Co-Investigator, Clinical Research Fellow
Royal Infirmary of Edinburgh