Outcomes of Motion-preserving Surgery and Arthrodesis at... | NCT03074916

Studies
Outcomes of Motion-preserving Surgery and Arthrodesis at the Distal Interphalangeal (DIP) Joint

NCT03074916

Sponsor

Schulthess Klinik

Status

Completed

Last Update Posted

Apr 26, 2018Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Distal Interphalangeal Arthroplasty
Distal Interphalangeal Arthrodesis

Interventions

DIP arthroplasty or arthrodesis

Countries

Switzerland

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

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 8, 2017Actual

Primary Completion Date

Apr 18, 2018Actual

Completion Date

Apr 18, 2018Actual

First Submitted Date

Feb 23, 2017

First Submission Date that Met QC Criteria

Mar 8, 2017

First Posted Date

Mar 9, 2017Actual

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

Apr 25, 2018

Last Update Posted Date

Apr 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 objective of this project is to investigate the subjective and clinical outcome in patients at least one year after DIP arthroplasty and compare them to matched patients with an arthrodesis.

The primary endpoint is the satisfaction with the treatment result of in the motion-preserving DIP surgery at follow-up.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DIP arthroplasty			Device: DIP arthroplasty or arthrodesis
DIP arthrodesis			Device: DIP arthroplasty or arthrodesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DIP arthroplasty or arthrodesis	Device	Arthroplasty of the DIP Joint or arthrodesis of the DIP joint	DIP arthrodesis DIP arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up	Question to be answered on a 5 Point Likert scale	at least 1 year up to 7 years

Secondary Outcomes

Measure	Description	Time Frame
Michigan Hand Questionnaire	Questionnaire about Hand function scored 0-100	at least 1 year up to 7 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Arthroplasty group:

DIP silicone arthroplasty at least one year ago
Informed consent as documented by signature

Arthrodesis group:

Matched patients with an DIP arthrodesis
Informed consent as documented by signature

Exclusion Criteria:

Arthroplasty group:

Silicone arthroplasty at the thumb IP joint
Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
Legal incompetence
German language barrier to complete the questionnaires

Arthrodesis group:

Arthroplasty at another DIP joint
Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
Legal incompetence
German language barrier to complete the questionnaires

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

111 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with a DIP arthroplasty at least one year ago Matched patients with a DIP arthrodesis

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Schulthess Klinik		Zurich		8008	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001174	Arthrodesis

Ancestor Terms

ID	Term
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided