A Prospective Randomised Trial of Non-operative Versus Operative Management of Olecranon Fractures in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- DASH
研究概览
简要总结
Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence regarding the optimal treatment and outcome of these fractures within the elderly population with one case series in the literature describing 13 patients. Our trial includes all patients equal to or over the age of 75yrs presenting to the Edinburgh and Fife Orthopaedic Trauma Units with an isolated olecranon fracture. Patients who consent to enrol in the trial will be randomised to operative fixation using one of two treatment methods. Patients in the nonoperative group will be place in a sling for two weeks and then allowed to mobilise under supervised physiotherapy as per normal protocol. For those patients in the operative group, tension band wire of plate fixation will be employed depending on the choice of their supervising consultant. Patients will be evaluated over a one year period following their treatment.
详细描述
Patients with undisplaced olecranon fractures can be treated non-operatively. The aims of treatment in displaced olecranon fractures are the restoration of function and stability to the elbow joint4. The technique employed should allow preservation and reconstruction of the articular surface with minimal associated complications. Tension-band wiring (TBW) is the most recognised and commonly used fixation method, although plate fixation and intramedullary screw fixation are noted alternatives. Potential problems with the TBW technique are wound breakdown, infection, prominent metalwork, malunion and non-union. Furthermore, plate fixation is considered to be superior in distal/comminuted/oblique fractures and fracture-dislocations, with superior fracture reduction and fixation results, as well as a lower rate of re-operation.
The above described fixation techniques can be employed in elderly people, although difficulties associated with fixation in osteoporotic bone, wound breakdown and other complications is reported. In these patients, fracture excision with advancement of the triceps is a viable option if fixation is deemed inappropriate. However, there is limited evidence to suggest that non-operative treatment of displaced olecranon fractures in these elderly patients may provide adequate functional results. In a case series of 13 patients (mean age 81.8 years, >5 mm fracture displacement) treated non-operatively for a displaced olecranon fracture, outcome scores were excellent in 11 patients and poor in one.
Research Aim To determine if any difference exists in outcome (primary measure - DASH score) after one year between non-operative management AND operative treatment for olecranon fractures in patients 75yrs or older (≥75yrs).
Methodology This trial involves identifying patients over the age of 75yrs (≥75yrs) presenting to the Edinburgh Orthopaedic Trauma Unit and Fife Orthopaedic Trauma Unit with an isolated olecranon fracture. Patients who consent to enrol in the trial will be randomised to one of two recognised treatment techniques - non-operative management in a collar and cuff for two weeks OR operative management using tension band wire fixation or plate fixation. The trial will commence once ethical approval is granted by the Lothian Research Ethics Committee.
All statistical analysis was/will be performed by Dr Rob Elton. Prior to the study a power analysis determined the number of patients required in each trial. The primary outcome measure will be the DASH score, a continuous variable that follows a normal (Gaussian-shaped) distribution. This study is designed to determine a clinically relevant mean difference of 10 points between the two cohorts at one year after enrolment. A power analysis indicated that a total sample size of 50 (25 in each group) subjects will provide 80% statistical power to detect significant differences (0.05) in DASH scores, assuming an effect size of 0.8 (mean difference of 10 points, standard deviation of 12 points) using an unpaired t-test. To account for a possible loss to follow-up of up to 25%, we anticipate enrolling 35 subjects in each cohort for a total sample size of 70 subjects. A p value of < 0.05 was considered statistically significant.
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)
入排标准
- 年龄范围
- 75 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥75 years
- •Minimal, moderate or severe fragmentation of the olecranon
- •Within two weeks of olecranon fracture
排除标准
- •Patients unable to give informed consent
- •Associated fractures to the coronoid, radial head and/or distal humerus
- •Associated ligamentous injury, dislocation or subluxation
- •Open fractures
研究组 & 干预措施
Non-operative
Patients in the non-operative arm will be managed conservatively using a sling, or an above elbow lightweight cast if problems with pain, for 10-14 days post injury. Patients will then be allowed to mobilise as able.
干预措施: Non-operative (Other)
Operative
Patients in this arm will be managed operatively for their olecranon fracture using either tension band wiring or plate fixation.
干预措施: Operative (Other)
结局指标
主要结局
DASH
时间窗: One year
Patient reported outcome measure specific to upper limb - DASH questionnaire at one year post injury/surgery.
次要结局
- Mayo Elbow Performance Index (MEPI(One year)
- Range of motion(One year)
- Pain(One year)
- Time taken to return to activities(One year)
- Radiographic Assessment(Six months)
研究者
Andrew D Duckworth
StR
Royal Infirmary of Edinburgh
