Trials Sponsors Conditions Drugs Pricing

Conditions

Avascular Necrosis of Humerus Implant Complication Proximal Humeral Fracture

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

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Oslo University Hospital
Otherlead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

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

Enrollment

38 participants (actual enrollment reported by the registry).

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

Actual (reported)

Pegs for Osteofixation of Proximal Humeral Fractures

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Group A: ALPS-PHP device

Group B: Philos device

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Group A: ALPS-PHP device

Group B: Philos device

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations