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

NCT05005364 | Unknown

• 1 other identifier: 2016/01241
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

• Incidence
• Health service utilization
• clinical and functional outcomes
• To estimate the relative cost-effectiveness of surgical vs non-surgical treatment pathways for managing patients with proximal humerus fractures.

Conditions

Proximal Humerus Fractures

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• EQ5D-5L - change over 6 weeks, 3, 6, 12 months

  Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months

• Costing questionnaire

  Assessed at 6 weeks, 3 months, 4.5 months, 6 months

Eligibility Criteria

• Age: 21 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with proximal humerus fracture going for surgical or conservative treatment option

You may qualify if:

• Age 21 years old and above
• Radiologically confirmed proximal humerus fracture
• Within 3 weeks of their injury

You may not qualify if:

• Open fracture
• Mentally incompetent patients
• Co-morbidities precluding anaesthesia
• Severe soft tissue compromise
• Neurovascular compromise
• Pathological fracture other than osteoporosis
• Surgery delayed \> 3 weeks
• Pregnancy

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

Study Officials

• Bryan Tan

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryan Tan

CONTACT

63577713; bryan_tan@whc.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 13, 2021
• Study Start: August 21, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 13, 2021

Record last verified: 2021-08

Locations

SG (1)