Clinical trial NCT05005364: Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus Fractures.
Official title: Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus Fractures.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proximal Humerus Fractures
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with proximal humerus fracture going for surgical or conservative treatment option

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Constant Shoulder Score - change over 6 weeks, 3, 6, 12 months
timeFrame: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
measure: Oxford Shoulder Score - change over 6 weeks, 3, 6, 12 months
timeFrame: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
measure: QuickDASH scoring - change over 6 weeks, 3, 6, 12 months
timeFrame: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary outcomes:
measure: EQ5D-5L - change over 6 weeks, 3, 6, 12 months
timeFrame: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
measure: Costing questionnaire
timeFrame: Assessed at 6 weeks, 3 months, 4.5 months, 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Bryan Tan
role: PRINCIPAL_INVESTIGATOR
References: