NCT00835562

Brief Summary

Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making. The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns. The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
162

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

Enrollment Period

3.9 years

First QC Date

February 2, 2009

Last Update Submit

June 6, 2012

Conditions

Proximal Humeral Fractures

Keywords

Shoulder fracturesProximal humeral fracturesRandomised clinical trialelderlyDisplaced four-part fractures of the proximal humerus

Outcome Measures

Primary Outcomes (1)

  • Constant Disability Scale

    3 years

Secondary Outcomes (1)

  • Oxford Shoulder Score, Short Form-36

    3 years

Study Arms (3)

Osteosynthesis

EXPERIMENTAL
Procedure: Osteosynthesis

Non-surgical

EXPERIMENTAL
Procedure: Non-surgical management

Hemiarthroplasty

EXPERIMENTAL
Procedure: Hemiarthroplasty

Interventions

Non-surgical managementPROCEDURE

Non-surgical management (physiotherapy and self-training)

Non-surgical
OsteosynthesisPROCEDURE

Osteosynthesis with angle-stable plate followed by physiotherapy and self-training

Osteosynthesis
HemiarthroplastyPROCEDURE

Primary modular hemiarthroplasty followed by physiotherapy and self-training

Hemiarthroplasty

Eligibility Criteria

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

You may qualify if:

  • Displaced four-part fracture of the proximal humerus
  • Mentally alert
  • Physically fit for surgery and rehabilitation (ASA-group 1-3)
  • Informed written consent
  • Operation can be conducted within 2 weeks of injury

You may not qualify if:

  • Fracture-dislocations
  • Head-splitting fractures
  • Previous shoulder surgery on injured side
  • Chronic shoulder pain
  • Abuse problems
  • Patients unable to understand instructions in Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev University Hospital, Department Orthopaedic Surgery

Herlev, Denmark, DK-2730, Denmark

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

Conditions

Shoulder Fractures

Interventions

Fracture Fixation, InternalHemiarthroplasty

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, OperativeArthroplasty, ReplacementArthroplastyPlastic Surgery ProceduresProsthesis Implantation

Central Study Contacts

Stig Brorson, MD, PhD

CONTACT

sbrorson@hotmail.com

Asbjørn Hrobjartsson, MD, PhD

CONTACT

ah@cochrane.dk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2013

Last Updated

June 7, 2012

Record last verified: 2012-06

Locations

DK(1)