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

10. august 2021 opdateret af: Bryan Tan, Tan Tock Seng Hospital

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

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Forventet)

400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Singapore
      • Singapore, Singapore
        • Rekruttering
        • Tan Tock Seng Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 110 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Constant Shoulder Score - change over 6 weeks, 3, 6, 12 months
Tidsramme: Assessed at baseline, 6 weeks, 3 months, 6 months, 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
Tidsramme: Assessed at baseline, 6 weeks, 3 months, 6 months, 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
Tidsramme: Assessed at baseline, 6 weeks, 3 months, 6 months, 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EQ5D-5L - change over 6 weeks, 3, 6, 12 months
Tidsramme: Assessed at baseline, 6 weeks, 3 months, 6 months, 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
Costing questionnaire
Tidsramme: Assessed at 6 weeks, 3 months, 4.5 months, 6 months
Questionnaire measuring the direct and indirect costs
Assessed at 6 weeks, 3 months, 4.5 months, 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tan Tock Seng Hospital

Efterforskere

  • Ledende efterforsker: Bryan Tan, Tan Tock Seng Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. august 2017

Primær færdiggørelse (Forventet)

31. december 2023

Studieafslutning (Forventet)

31. december 2023

Datoer for studieregistrering

Først indsendt

10. august 2021

Først indsendt, der opfyldte QC-kriterier

10. august 2021

Først opslået (Faktiske)

13. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2016/01241

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Proksimale humerusfrakturer

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