Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years: a Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Oxford Shoulder Score 12 months
研究概览
简要总结
The goal of this clinical trial is to study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture.
The main questions it aims to answer are:
• Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up?
Aim is also to characterize the patient group aged 50-65 regarding fracture morphology, osteoporosis, and clinical frailty scale.
The study compare operation with either plate or nail fixation to non-surgical treatment.
Participants will:
- Receive either surgical treatment or non-surgical treatment.
- At 6 months, 1 year, and 2 years, the patient will answer two short questionnaires (Oxford Shoulder Score and Eq-5D-3L).
The primary outcome will be Oxford Shoulder Score at 12 months. The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points. Adverse events and conversion to surgery will be registered. OSS and EQ-5D-3L will be completed just before the 6 months visit.
详细描述
Proximal humerus fractures (PHF) are common injuries. At the age of 60 and above, no clinically important difference between surgical and non-surgical treatment after one year has been reported based on a recent Cochrane review of 10 trials.
The treatment of choice for displaced PHF in adults 50-65 years is anatomical reconstruction, and osteosynthesis if possible, which is why many patients in this age group with a displaced PHF undergo surgical treatment.
Orthopaedic surgeons may encounter challenges in guiding patients and formulating treatment strategies within specific age groups due to the absence of inclusion of this younger patient demographic in existing evidence. Knowledge is primarily derived from studies on the population aged 60 years and above. There exists an intermediate age group of patients for whom it remains uncertain whether the benefits and harms of non-surgical and surgical interventions are comparable
This trial is a two-center, parallel-group, randomized, superiority trial comparing osteosynthesis with non-surgical treatment following a displaced proximal humerus fractures in patients aged 50-65 years. The participants will be included and allocated equally to surgical treatment with osteosynthesis (comparator) with non-surgical treatment (intervention).
The surgical group will visit the outpatient clinic after 2, 12, and 24 weeks, while the non-surgical group will visit after 6, (12) and 24 weeks. X-rays will be obtained before every visit.
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
- Single (Outcomes Assessor)
盲法说明
The primary investigator will conduct the blinded statistical analysis through data anonymization and will be supervised by a biostatistician. After the blinded statistical analysis has been completed, two abstracts will be written based on the pre-blinding analysis results before the blinding is revealed.
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 50 and 65 years with a displaced PHF assessed to be constructible by the treating surgeon after a low-energy trauma will be considered for eligibility.
- •Patients should be cognitively capable of answering the follow-up questionnaires.
排除标准
- •The patient does not understand written and spoken native language (Danish or Finnish/Swedish)
- •Inability to give informed consent
- •Fractures assessed to be unreconstructedly by the treating surgeon
- •Isolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface
- •Less than 25% contact between head fragment and metaphysis/diaphysis measured at two perpendicular radiographs at two weeks.
- •Pathological fractures or previous fractures in the same proximal humerus
- •Concomitant fractures, which could influence the outcome
- •Paralysis in upper extremity
结局指标
主要结局
Oxford Shoulder Score 12 months
时间窗: 12 months
Oxford Shoulder Score is a patient-reported shoulder-specific outcome measure. It is a patient-administrated questionnaire to assess shoulder function. It consists of 12 questions on a 5-point Likert scale (both pain- and function-related), each offering five ordinal response options. The cumulative score ranges between 0 and 48, being 0 (worst) to 48 (best: no pain or no functional limitation).
次要结局
- Oxford Shoulder Score(6 and 24 months)
- EQ-5D-3L(6, 12 and 24 months)
- Adverse events.(24 months)
- Conversion to surgery after inclusion, or additional surgery(24 months)
研究者
Line Lojbert Houkjaer
Principal Investigator, M.D.
Zealand University Hospital