search
Back to results

Reconstruction of Complex Proximal Humeral Fractures.

Primary Purpose

Osteoarthritis of the Shoulder, Complexe Proximal Humeral Fractures

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Shoulder replacement surgery
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Shoulder focused on measuring osteoarthritis, complexe proximal humeral fracture, shoulder, shoulder replacement, accuracy, computer-assisted, 3D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • osteoarthritis or complexe proximal humeral fracture and indication for shoulder arthroplasty
  • patients > 18years

Exclusion Criteria:

  • contraindication for computertomography
  • pregnancy
  • previous fracture or shoulder replacement of the contralateral side in case of a complexe proximal humeral fracture

Sites / Locations

  • University Hospital Balgrist

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computer-assisted 3D planning

Arm Description

Realization of the fracture reconstruction according to the computer-assisted 3D preoperative plan

Outcomes

Primary Outcome Measures

Quantitative analysis of the accuracy of an automatic algorithm for the reconstruction of proximal humeral fractures
Accuracy of the reconstruction of complex proximal humeral fractures.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2014
Last Updated
November 24, 2017
Sponsor
Balgrist University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02052206
Brief Title
Reconstruction of Complex Proximal Humeral Fractures.
Official Title
Reconstruction of Complex Proximal Humeral Fractures.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balgrist University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in realization a computer assisted 3D planning compared to conventional 2D planning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Shoulder, Complexe Proximal Humeral Fractures
Keywords
osteoarthritis, complexe proximal humeral fracture, shoulder, shoulder replacement, accuracy, computer-assisted, 3D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer-assisted 3D planning
Arm Type
Experimental
Arm Description
Realization of the fracture reconstruction according to the computer-assisted 3D preoperative plan
Intervention Type
Procedure
Intervention Name(s)
Shoulder replacement surgery
Primary Outcome Measure Information:
Title
Quantitative analysis of the accuracy of an automatic algorithm for the reconstruction of proximal humeral fractures
Description
Accuracy of the reconstruction of complex proximal humeral fractures.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: osteoarthritis or complexe proximal humeral fracture and indication for shoulder arthroplasty patients > 18years Exclusion Criteria: contraindication for computertomography pregnancy previous fracture or shoulder replacement of the contralateral side in case of a complexe proximal humeral fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lazaros Vlachopoulos, MD
Organizational Affiliation
Balgrist University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Balgrist
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727196
Citation
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.
Results Reference
derived

Learn more about this trial

Reconstruction of Complex Proximal Humeral Fractures.

We'll reach out to this number within 24 hrs