NCT03108716

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

April 5, 2017

Last Update Submit

April 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Time of plaster fixation

    At 6-18 months after surgery

Study Arms (3)

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

The patients were assigned to treat with hamate hook removal.

hamate hook removal

The patients were assigned to treat with microscrew internal fixation after open reduction.

microscrew internal fixation

The patients were assigned to treat with short-arm tube-type plaster fixation (conservative treatment).

short-arm tube-type plaster fixation

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Incomplete follow-up data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Zhuang Liu, Ph.D

    Siping Central People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The investigators collected data of 28 hamate hook fractures patients, who were treated in the Siping Central People's Hospital and had complete follow-up records.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 11, 2017

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

June 1, 2013

Last Updated

April 11, 2017

Record last verified: 2017-04