NCT04622852

Brief Summary

Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

3.2 years

First QC Date

November 3, 2020

Last Update Submit

September 12, 2021

Conditions

Implant ComplicationProximal Humeral FractureAvascular Necrosis of Humerus

Keywords

Humeral headScrew penetrationPeg penetrationAvascular necrosis

Outcome Measures

Primary Outcomes (2)

  • Peg penetration into glenohumeral joint

    Radiographic or CT verified peg penetration

    12 months

  • Screw penetration into glenohumeral joint

    Radiographic or CT verified screw penetration

    12 months

Secondary Outcomes (4)

  • Humeral head deformation

    12 months

  • Shoulder function

    12 months

  • Self reported shoulder function

    12 months

  • Quality of life

    12 months

Study Arms (2)

Group A: ALPS-PHP device

Patients operated with angular stable plate for displaced PHF with an ALPS plate

Device: Open reduction internal fixation (ORIF) with an angular stable plate

Group B: Philos device

Patients operated with angular stable plate for displaced PHF with a Philos plate

Device: Open reduction internal fixation (ORIF) with an angular stable plate

Interventions

Open reduction internal fixation (ORIF) with an angular stable plateDEVICE

Operative treatment of proximal humeral fracture

Group A: ALPS-PHP deviceGroup B: Philos device

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to hospital with an acute PHF for surgical treatment

You may not qualify if:

  • Not eligible to surgical treatment
  • Non-compliant
  • Former shoulder fracture or symptomatic shoulder illness
  • Drug abuser

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

  • Bones I, Karlberg AC, Liljeholm M, Fraser AN, Madsen JE, Fjalestad T. Pegs not superior to screws for fixation of fractures of the proximal humerus. J Orthop Surg Res. 2022 Feb 2;17(1):66. doi: 10.1186/s13018-022-02947-3.

    PMID: 35109905DERIVED

MeSH Terms

Conditions

Shoulder FracturesOsteonecrosis

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder InjuriesBone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tore Fjalestad, MD, PhD.

    Oslo University Hospital, Ortophaedic Dept.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD. Senior Consultant Ortophaedic Surgeon

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 10, 2020

Study Start

July 1, 2017

Primary Completion

September 1, 2020

Study Completion

August 1, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations

NO(1)