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Clinical Trials/ISRCTN76296703
ISRCTN76296703
Active, not recruiting
未知

PROximal Fracture of the Humerus: Evaluation by Randomisation trial no. 2 (PROFHER-2 trial): a three-arm randomised controlled trial to assess the effectiveness and cost-effectiveness of reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical care for acute three and four-part fractures of the proximal humerus in patients over 65 years of age

South Tees Hospitals NHS Foundation Trust0 sites359 target enrollmentApril 5, 2018
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ConditionsThree and four part proximal humeral fracturesInjury, Occupational Diseases, PoisoningFracture of shoulder and upper arm

Overview

Phase
未知
Intervention
Not specified
Conditions
Three and four part proximal humeral fractures
Sponsor
South Tees Hospitals NHS Foundation Trust
Enrollment
359
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 5, 2018
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Adult patients aged 65 years or over
  • •2\. Radiographically confirmed acute three\-part (including surgical neck) or four\-part displaced fracture of the proximal humerus (Neer Classification) including head\-splitting fractures of the humeral head and fracture dislocations
  • •3\. Trial interventions can be provided within 5 weeks of injury
  • •4\. Patient is deemed by the clinical care team to be fit for surgery
  • •5\. Able to provide full informed consent

Exclusion Criteria

  • •1\. Patients who are unable to adhere to trial procedures or complete questionnaires
  • •2\. Polytrauma – where one or more additional fractures, which may affect the outcome measures for the trial, are present or other body\-systems are affected
  • •3\. Open fractures or fractures where there is severe soft tissue compromise requiring urgent surgery
  • •4\. Pathological (other than osteoporotic) fractures
  • •5\. Presence of axillary nerve palsy (given that this results in a weakening of the deltoid muscle, upon which the shoulder relies for function)

Outcomes

Primary Outcomes

Not specified

Similar Trials

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