Hamate Hook Removal, Microscrew Internal Fixation and Pla... | NCT03108716

Studies
Hamate Hook Removal, Microscrew Internal Fixation and Plaster Fixation for the Treatment of Hamate Hook Fractures

NCT03108716

Sponsor

Siping Central People's Hospital

Status

Completed

Last Update Posted

Apr 11, 2017Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Fractures, Bone

Interventions

hamate hook removal
microscrew internal fixation
short-arm tube-type plaster fixation

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

Apr 2017

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

Jan 2011Actual

Primary Completion Date

Jan 2012Actual

Completion Date

Jun 2013Actual

First Submitted Date

Apr 5, 2017

First Submission Date that Met QC Criteria

Apr 5, 2017

First Posted Date

Apr 11, 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 5, 2017

Last Update Posted Date

Apr 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhuang Liu, Principal Investigator, Siping Central People's HospitalPrincipal Investigator

Lead Sponsor

Siping Central People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To compare the effects of hamate hook removal, microscrew internal fixation and plaster fixation on fracture healing, work, life, and exercise recovery in patients with hamate hook fractures by retrospective case analysis.

Detailed Description

Hamate hook fractures are rare, and mainly occur during sports activities. Its projection is often obscured by other carpal bone in conventional X-ray plain films, so hamate hook fractures are the most easily missed injury in hand surgery. As the incidence of such fractures is too small, it brings some difficulties in the clinical choice of correct and effective treatment. Currently, treatment programs of hamate hook fractures also are not consistent.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hamate hook removal	Experimental	The patients were assigned to hamate hook removal(n=13).	Procedure: hamate hook removal
microscrew internal fixation	Experimental	The patients were assigned to the microscrew internal fixation after open reduction (n=11).	Procedure: microscrew internal fixation
short-arm tube-type plaster fixation	Experimental	The patients were assigned to the short-arm tube-type plaster fixation (conservative treatment) (n=4).	Other: short-arm tube-type plaster fixation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hamate hook removal	Procedure	The patients were assigned to treat with hamate hook removal.	hamate hook removal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fracture healing	Fracture healing was assessed using CT images or X-ray films at the wrist position holding a cup.	At 6-18 months after surgery

Secondary Outcomes

Measure	Description	Time Frame
Time of plaster fixation	To reflect fracture healing; the shorter the fixation time, the faster the healing	At 6-18 months after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hamate hook fractures finally diagnosed by X-ray and CT scan at the wrist position holding a cup and the carpal canal position (appendix 2)
Unilateral hamate hook fractures
Irrespective of age and sex

Exclusion Criteria:

Incomplete follow-up data

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
Zhuang Liu, Ph.D	Siping Central People's Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided