Longterm Outcome of the Delta III Inverse Prosthesis | NCT01873651

Studies
Longterm Outcome of the Delta III Inverse Prosthesis

NCT01873651

Sponsor

Schulthess Klinik

Status

Withdrawn

Last Update Posted

Aug 11, 2014Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Rotator Cuff Tear Arthropathy

Interventions

Implantation of a Delta III Prosthesis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study has been withdrawn due to too few patients

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Mar 2014Estimated

First Submitted Date

Jun 5, 2013

First Submission Date that Met QC Criteria

Jun 5, 2013

First Posted Date

Jun 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2014

Last Update Posted Date

Aug 11, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthias Flury, Principal Investigator (Department of Upper Extremity), Schulthess KlinikPrincipal Investigator

Lead Sponsor

Schulthess KlinikOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The aim of the study is to measure the gain of the benefit in function an painreduction which the patient yields with this type of prosthesis in a longterm (> 10 years )outcome. Additionally the long-term results will be compared with the mid-term results and the literature. Furthermore the complications since the mid-term measurement time point will be determined.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Delta III	Experimental	Implantation of a Delta III Prosthesis	Device: Implantation of a Delta III Prosthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantation of a Delta III Prosthesis	Device	Implantation of a Delta III Prosthesis	Delta III

Measure	Description	Time Frame
Constant Murley Score		10 years

Measure	Description	Time Frame
cASES		10 years
pASES		10 years
SF-36		10 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias Flury, Dr.	Schulthess Klinik, Upper Extremities Department	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070656	Rotator Cuff Tear Arthropathy

Ancestor Terms

ID	Term
D002805	Chondrocalcinosis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided