Follow-up for Locking Plate Fixaion of Distal Radius Frac... | NCT03556514

Studies
Follow-up for Locking Plate Fixaion of Distal Radius Fracture

NCT03556514

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Unknown status

Last Update Posted

Jun 14, 2018Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Distal Radius Fracture

Interventions

Not provided

Countries

Taiwan

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

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2017Actual

Primary Completion Date

May 9, 2019Estimated

Completion Date

May 9, 2019Estimated

First Submitted Date

Jun 4, 2018

First Submission Date that Met QC Criteria

Jun 4, 2018

First Posted Date

Jun 14, 2018Actual

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

Jun 4, 2018

Last Update Posted Date

Jun 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 current status of the disease under study. Including natural history, disease prognosis.

Distal radial fractures (DRF, distal radius fractures) are the most common fractures, allowing the user to lock the steel plate to accelerate the recovery of the wrist, but related injuries such as the triangular fibrocartilage cartilage complex (TFCC) tear or distal radius ulna joint (DRUJ) ligament tear with DRUJ instability requires time fixed or further repair surgery. If these issues are ignored, there will be weakness in the future. The ulnar shortening commonly used by hand surgeons is to improve the damage of TFCC or DRUJ instability. In the case of distal radial fracture combined with DRUJ instability, it is not clear that the distal radial fracture combined with DRUJ instability patients has long-term prognosis.

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

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
4-Item Pain intensity Measure	Each item is scored 0-10(0=no pain;10=pain as bad as can be)	5 seconds

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatient following for at least one year

Exclusion Criteria:

(1) Injury or arthritis before; (2) Open fractures, or more wounds require surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Acute distal humerus fracture after interlocking plate fixation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jung-Pan Wang, M.D.,Ph.D.	Contact	02-28757557	1125	jpwang801@gmail.com

Overall Officials

Name	Affiliation	Role
Jung-Pan Wang, M.D.,Ph.D.	Taipei Veterans General Hospital, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Veterans General Hospital	Recruiting	Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D000092503	Wrist Fractures

Ancestor Terms

ID	Term
D014954	Wrist Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided