NCT04106674

Brief Summary

The proximal humerus fracture (PHFs) is the third most common fracture type in the elderly, and represents 5% of the overall fractures. The incidence is increasing. The purpose of the project is to compare surgical and conservative management of two- part PHFs in light of radiological, economical and clinical outcome. Do the participants between 60 and 85 years of age with displaced two-part PHFs fare better or worse after surgery compared to non-operative treatment?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
103mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Oct 2020Oct 2034

First Submitted

Initial submission to the registry

September 23, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
10.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2034

Expected
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

4 years

First QC Date

September 23, 2019

Last Update Submit

October 24, 2022

Conditions

Proximal Humerus Fracture2 Part Fracture

Keywords

Proximal humerus fractureNon-operative versus operative treatmentConservative versus surgical treatmentSurgical versus non-surgical treatment

Outcome Measures

Primary Outcomes (1)

  • Quick Dash

    Prom, The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5). This is a 100-points scale where 0 is perfect/ best and 100 is the worst possible outcome

    1 year

Secondary Outcomes (5)

  • Constant-Murley score

    1 year

  • EQ5D

    1 year

  • Radiology

    1 year

  • Number of patients with complications such as infection, Avascular necrosis, failure of osteosynthesis, screw cut out, nerve damage, deep vein thrombosis,

    1 year

  • Visual Analog scale (VAS score)

    1 year

Study Arms (2)

Non-surgical

NO INTERVENTION

No surgery

Surgical

ACTIVE COMPARATOR

Surgeons preference

Procedure: Open reduction internal stabilisation (ORIF)

Interventions

Open reduction internal stabilisation (ORIF)PROCEDURE

Treatment allocated to surgical or non-surgical group. Implant choice pragmatic, surgeons choice.

Also known as: Surgery
Surgical

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 60 years and \<85 years
  • More than 50% displacement between head or shaft or 50⁰ angulation of the head against the shaft in Y-projection or more than 45 ˚ valgus or more than 30˚ varus of the Head Shaft Angle (HSA).
  • Patient with tuberculum majus or minor fractures which displaced \<5mm can be included as long as points 1 and 2 above are fulfilled.

You may not qualify if:

  • Refusal to participate in the study
  • Fracture more than 3 weeks old
  • No contact btw head and shaft
  • Ipsilateral damage that will influence the recovery and scoring systems
  • Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity. This is up to the treating surgeon to decide
  • Pathological fracture or previous fracture of the same proximal humerus
  • Multitrauma or "multifractured patient"
  • Neurovascular injury
  • Open fracture
  • Noncompliance, dementia and/ or institutionalized
  • Congenital anomaly
  • Ongoing infectious process around the incision site for osteosynthesis
  • Systemic disease that may influence healing processes or scoring systems (in example Rheumatoid arthritis/Multiple sclerosis/ poorly controlled DM)
  • Fracture dislocation
  • Substance abuse
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lørenskog, Oslo County, 0587, Norway

RECRUITING

Related Publications (1)

  • Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

    PMID: 35727196DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Asbjørn Aarøen, Professor

    Akershus Universitetssykehus HF

    STUDY DIRECTOR

Central Study Contacts

Annette Konstanse Bordewich Wikerøy, MD

CONTACT

004799717481awikeroy@hotmail.com

Hendrik Fuglesang, MD, PhD

CONTACT

drhendrik@me.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The physiotherapists conducting outcomes at 6 months and 1 year do not know if patients are treated with surgery or not. Patients are instructed to wear t-shirt and not talk about treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with 2 arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Head of orthopedic trauma unit

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 27, 2019

Study Start

October 1, 2020

Primary Completion

October 1, 2024

Study Completion (Estimated)

October 31, 2034

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations

NO(1)