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CompletedNCT04622852Updated Sep 14, 2021

Pegs for Osteofixation of Proximal Humeral Fractures

An observational study in Implant Complication, Proximal Humeral Fracture and Avascular Necrosis of Humerus, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-09-14.

Sponsored by Oslo University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
38
Ages
55 Years to 90 Years
Sex
All
01

Study summary

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

Read the detailed description

From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007 fracture classification were selected according to age and gender to be compared with patients operated with a Philos plate within the same fracture group, age and gender to be matched for adverse events:

  1. Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and
  2. Avascular head necrosis / sinking / need of re-surgery
  3. Clinical PROMS
02

Conditions studied

  • Implant Complication
  • Proximal Humeral Fracture
  • Avascular Necrosis of Humerus

Keywords

  • Humeral head
  • Screw penetration
  • Peg penetration
  • Avascular necrosis
03

In context

Necrosis

477 studies on the registry are indexed under Necrosis; 54 are open to participants now.

This study's enrollment of 38 is below the median of 100 across 147 observational studies indexed under Necrosis.

Browse Necrosis studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to hospital with an acute PHF for surgical treatment

Inclusion criteria

  • Acute proximal humeral fracture
  • AO/OTA type 11-B2 or 11C2

Exclusion criteria

Exclusion Criteria:

  • Not eligible to surgical treatment
  • Non-compliant
  • Former shoulder fracture or symptomatic shoulder illness
  • Drug abuser
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
38 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceOpen reduction internal fixation (ORIF) with an angular stable plate

    Operative treatment of proximal humeral fracture

06

What researchers measure

Primary outcomes

  1. Peg penetration into glenohumeral joint

    Radiographic or CT verified peg penetration

    Time frame: 12 months

  2. Screw penetration into glenohumeral joint

    Radiographic or CT verified screw penetration

    Time frame: 12 months

Secondary outcomes

  1. Humeral head deformation

    Avascular head necrosis or Sinking

    Time frame: 12 months

  2. Shoulder function

    Constant-Murley score

    Time frame: 12 months

  3. Self reported shoulder function

    Oxford scoulder score

    Time frame: 12 months

  4. Quality of life

    Generic 15D score

    Time frame: 12 months

07

Study locations

1 site
  • Oslo University Hospital
    Oslo, Norway
08

References and documents

Publications

  • 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. PubMed 35109905 ↗

Individual participant data

Plan to share: Undecided — No plan has been decided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04622852
Lead sponsor
Oslo University Hospital
Responsible party
Tore Fjalestad (MD. PhD. Senior Consultant Ortophaedic Surgeon, Oslo University Hospital) — Principal investigator
First posted
Nov 10, 2020
Start date
Jul 1, 2017
Primary completion
Sep 1, 2020
Completion
Aug 1, 2021
Last update
Sep 14, 2021

Study contacts

Tore Fjalestad, MD, PhD.
principal investigator · Oslo University Hospital, Ortophaedic Dept.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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