Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus Fractures.

Proximal Humerus Fractures Clinical Trial

— SPHEER  

Official title:

Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus Fractures.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05005364
• Other study ID #: 2016/01241
• Status: Recruiting
• Start date: August 21, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: Tan Tock Seng Hospital
• Contact: Bryan Tan
• Phone: 63577713
• Email: bryan_tan[@]whc.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With an ageing population, fragility fractures secondary to osteoporosis are on a increasing trend. Proximal humerus fractures are common fractures which account for a significant proportion of these fragility fractures. They significantly affect patients function and independence particularly in the elderly.

Currently, treatment options range from conservative treatment with an arm sling to fixation either with plates or intramedullary devices to arthroplasty ranging from a hemiarthroplasty to the latest reverse shoulder arthroplasty. While is there has been a global trend towards surgical treatment for such fractures, there is significant controversy regarding the best treatment with many studies reporting disappointing functional outcomes including residual shoulder pain, limitation in shoulder motion and decreased quality of life regardless of treatment option selected.

In this day and age where healthcare cost is a big concern both at the individual patient level but at a government level as well, evaluating the cost effectiveness of treatment becomes essential as well. Currently in Singapore, there have been a significant trend of an increased use of surgical treatment of proximal humerus fractures however we have very little data in our local context not only to evaluate the clinical effectiveness but also the cost effectiveness of surgical treatment in comparison to conservative treatment.

The primary aim of the study is

1. To understand the epidemiology and prognostic factors for proximal humerus fractures

• Incidence

• Health service utilization

• clinical and functional outcomes

2. To estimate the relative cost-effectiveness of surgical vs non-surgical treatment pathways for managing patients with proximal humerus fractures.

We hypothesize that surgical fixation of the proximal humerus is both clinically and cost effective

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 110 Years

Eligibility

Inclusion Criteria:

1. Age 21 years old and above

2. Radiologically confirmed proximal humerus fracture

3. Within 3 weeks of their injury

Exclusion Criteria:

1. Open fracture

2. Mentally incompetent patients

3. Co-morbidities precluding anaesthesia

4. Severe soft tissue compromise

5. Neurovascular compromise

6. Pathological fracture other than osteoporosis

7. Surgery delayed > 3 weeks

8. Pregnancy

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humerus Fractures

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant Shoulder Score - change over 6 weeks, 3, 6, 12 months	To evaluate the clinical outcomes over time by comparing the change in constant shoulder score over a period of 1 year. The Constant Shoulder Score is used to assess the level of pain and the patient's ability to carry out normal daily activities.; Constant score of the unaffected shoulder was also assessed at baseline to compare the function between the two shoulders.	Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
Primary	Oxford Shoulder Score - change over 6 weeks, 3, 6, 12 months	A 12-item patient-report questionnaire developed to evaluate the outcome of shoulder surgery, excluding surgery for instability. The OSS contains two subscales, pain and activities of daily living. Each responses is of a 0-4 scoring format with a higher score representing better function. Hence, the highest possible total score is 48 and a higher score represents a better outcome.	Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
Primary	QuickDASH scoring - change over 6 weeks, 3, 6, 12 months	This score is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).	Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary	EQ5D-5L - change over 6 weeks, 3, 6, 12 months	EuroQol-5 Dimensions (EQ-5D) consists of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by selecting the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome.	Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary	Costing questionnaire	Questionnaire measuring the direct and indirect costs	Assessed at 6 weeks, 3 months, 4.5 months, 6 months