Pegs for Osteofixation of Proximal Humeral Fractures

September 12, 2021 updated by: Tore Fjalestad, Oslo University Hospital

Are Pegs Better Than Screw for Osteofixation of Proximal Humeral Fractures?

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to hospital with an acute PHF for surgical treatment

Description

Inclusion Criterion:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Operative treatment of proximal humeral fracture
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
Operative treatment of proximal humeral fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peg penetration into glenohumeral joint
Time Frame: 12 months
Radiographic or CT verified peg penetration
12 months
Screw penetration into glenohumeral joint
Time Frame: 12 months
Radiographic or CT verified screw penetration
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humeral head deformation
Time Frame: 12 months
Avascular head necrosis or Sinking
12 months
Shoulder function
Time Frame: 12 months
Constant-Murley score
12 months
Self reported shoulder function
Time Frame: 12 months
Oxford scoulder score
12 months
Quality of life
Time Frame: 12 months
Generic 15D score
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Tore Fjalestad, MD, PhD., Oslo University Hospital, Ortophaedic Dept.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 7, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 12, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/681

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

No plan has been decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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