NCT01873651

Brief Summary

The aim of the study is to describe the results after \> 10 years due to a prosthesis implant.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Status
withdrawn

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

June 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

2 months

First QC Date

June 5, 2013

Last Update Submit

August 8, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Constant Murley Score

    10 years

Secondary Outcomes (9)

  • cASES

    10 years

  • pASES

    10 years

  • SF-36

    10 years

  • DASH-Questionannaire

    10 years

  • SPADI

    10 years

  • +4 more secondary outcomes

Study Arms (1)

Delta III

EXPERIMENTAL

Implantation of a Delta III Prosthesis

Device: Implantation of a Delta III Prosthesis

Interventions

Implantation of a Delta III Prosthesis

Delta III

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • implantation of a Delta III - prothesis
  • timeframe (Oct 1998 - Dec 2002)
  • delta-pectoral approach
  • written informed consent

You may not qualify if:

  • Implantation because of a revision
  • Complaints, which make it difficult to follow instructions or even prevent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

ChondrocalcinosisArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Study Officials

  • Matthias Flury, Dr.

    Schulthess Klinik, Upper Extremities Department

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (Department of Upper Extremity)

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 10, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

August 11, 2014

Record last verified: 2014-08