Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- DASH - the Disabilities of the Arm, Shoulder and Hand
研究概览
简要总结
Research question:
Do patients using a neutral rotation brace post surgery have improved functional outcome and external rotation of the shoulder compared to current best practice using a polysling holding the proximal humerus in internal rotation?
Primary objectives:
To compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks and 1 year) between patients held in neutral versus current standard rotation. These will be compared to scores taken pre-operatively.
Benefits:
There may be no extra benefits to patients from this trial however the results from the trial will help improve treatment for future patients at this hospital, and others across the country.
Risks/disadvantages:
The operation is the same in both groups studied, the study is investigating the use of the two different slings. The post-operative treatment is also the same, and all patients on the trial will receive the same amount of physiotherapy. It isn't anticipated that there will be any additional risk from this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proximal humeral fractures requiring operative intervention with extramedullary plate fixation (i.e. fractures displaced by 1cm and/or angulated by 45 degrees or more)
- •Age over 18 years of age
- •Patient able to give informed consent
排除标准
- •Patients having intra-operative findings to complete Pectoralis major rupture or if operative exposure requires complete Pectoralis major tenotomy. (These patients need to be held in internal rotation with a standard polysling to allow healing of the Pectoralis major tendon)
- •Patients under 18 years of age
- •Patients unable to give informed consent
研究组 & 干预措施
Neutral Rotation Brace
Neutral Rotation Brace
干预措施: Operative procedure to fix proximal humeral (Procedure)
Neutral Rotation Brace
Neutral Rotation Brace
干预措施: Neutral Rotation Brace (Device)
Neutral Rotation Brace
Neutral Rotation Brace
干预措施: Physiotherapy review (Other)
Neutral Rotation Brace
Neutral Rotation Brace
干预措施: Functional outcome forms filled in (Other)
Neutral Rotation Brace
Neutral Rotation Brace
干预措施: Postal functional outcome scores (Other)
Neutral Rotation Brace
Neutral Rotation Brace
干预措施: Post-operative Radiographs (Other)
Standard polysling (Current practice)
Standard polysling (Current practice)
干预措施: Operative procedure to fix proximal humeral (Procedure)
Standard polysling (Current practice)
Standard polysling (Current practice)
干预措施: Neutral Rotation Brace (Device)
Standard polysling (Current practice)
Standard polysling (Current practice)
干预措施: Physiotherapy review (Other)
Standard polysling (Current practice)
Standard polysling (Current practice)
干预措施: Functional outcome forms filled in (Other)
Standard polysling (Current practice)
Standard polysling (Current practice)
干预措施: Postal functional outcome scores (Other)
Standard polysling (Current practice)
Standard polysling (Current practice)
干预措施: Post-operative Radiographs (Other)
结局指标
主要结局
DASH - the Disabilities of the Arm, Shoulder and Hand
时间窗: 1 year post surgery
DASH Scoring system was developed to assess the level of disability for any patient with any condition affecting the upper limb by covering domains including symptoms, physical function and psychological function
Oxford score
时间窗: 1 Year post surgery
Patients subjective assessment of pain and Activities of Daily Living (ADL) impairment. The Oxford Shoulder Questionnaire has been shown to correlate well with both the Constant Score and the SF36 assessment and to be sensitive to surgical intervention. The Oxford Shoulder Questionnaire accumulates to a total score with a maximum of value of 60, in which four pain related questions make up 33% of this total whilst the remaining 67% is derived from eight ADL related questions. The highest scores are attributed to the worst outcomes in the Oxford Shoulder Questionnaire
次要结局
- Range of movement(flexion, extension, abduction, external and internal rotation)(6 weeks, 3 months and 1 year)
- SF-12 Score(1 Year post surgery)
- Range of movement (flexion, extension, abduction and internal rotation)(6 weeks, 6 months and 1 year)
- Time to union of fracture(6 weeks and 3 Months)
- Return to work post surgery(1 year follow up)
- Re-operations and Complications(Throughout 1st year as applicable at outpatient appointments)