NCT02052206

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

January 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

3.7 years

First QC Date

January 30, 2014

Last Update Submit

November 24, 2017

Conditions

Osteoarthritis of the ShoulderComplexe Proximal Humeral Fractures

Keywords

osteoarthritiscomplexe proximal humeral fractureshouldershoulder replacementaccuracycomputer-assisted3D

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Study Arms (1)

Computer-assisted 3D planning

EXPERIMENTAL

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

Procedure: Shoulder replacement surgery

Interventions

Shoulder replacement surgeryPROCEDURE
Computer-assisted 3D planning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Balgrist

Zurich, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 35727196DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Lazaros Vlachopoulos, MD

    Balgrist University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 3, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 27, 2017

Record last verified: 2017-11

Locations

CH(1)