Back to resultsHamate Hook Removal, Microscrew Internal Fixation and Plaster Fixation for the Treatment of Hamate Hook Fractures
Primary Purpose
Fractures, Bone
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hamate hook removal
microscrew internal fixation
short-arm tube-type plaster fixation
Sponsored by
About this trial
This is an interventional treatment trial for Fractures, Bone
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
hamate hook removal
microscrew internal fixation
short-arm tube-type plaster fixation
Arm Description
The patients were assigned to hamate hook removal(n=13).
The patients were assigned to the microscrew internal fixation after open reduction (n=11).
The patients were assigned to the short-arm tube-type plaster fixation (conservative treatment) (n=4).
Outcomes
Primary Outcome Measures
Fracture healing
Fracture healing was assessed using CT images or X-ray films at the wrist position holding a cup.
Secondary Outcome Measures
Time of plaster fixation
To reflect fracture healing; the shorter the fixation time, the faster the healing
Full Information
NCT ID
NCT03108716
First Posted
April 5, 2017
Last Updated
April 5, 2017
Sponsor
Siping Central People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03108716
Brief Title
Hamate Hook Removal, Microscrew Internal Fixation and Plaster Fixation for the Treatment of Hamate Hook Fractures
Official Title
Hamate Hook Removal, Microscrew Internal Fixation and Plaster Fixation for the Treatment of Hamate Hook Fractures: a Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siping Central People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hamate hook removal
Arm Type
Experimental
Arm Description
The patients were assigned to hamate hook removal(n=13).
Arm Title
microscrew internal fixation
Arm Type
Experimental
Arm Description
The patients were assigned to the microscrew internal fixation after open reduction (n=11).
Arm Title
short-arm tube-type plaster fixation
Arm Type
Experimental
Arm Description
The patients were assigned to the short-arm tube-type plaster fixation (conservative treatment) (n=4).
Intervention Type
Procedure
Intervention Name(s)
hamate hook removal
Intervention Description
The patients were assigned to treat with hamate hook removal.
Intervention Type
Procedure
Intervention Name(s)
microscrew internal fixation
Intervention Description
The patients were assigned to treat with microscrew internal fixation after open reduction.
Intervention Type
Other
Intervention Name(s)
short-arm tube-type plaster fixation
Intervention Description
The patients were assigned to treat with short-arm tube-type plaster fixation (conservative treatment).
Primary Outcome Measure Information:
Title
Fracture healing
Description
Fracture healing was assessed using CT images or X-ray films at the wrist position holding a cup.
Time Frame
At 6-18 months after surgery
Secondary Outcome Measure Information:
Title
Time of plaster fixation
Description
To reflect fracture healing; the shorter the fixation time, the faster the healing
Time Frame
At 6-18 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuang Liu, Ph.D
Organizational Affiliation
Siping Central People's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hamate Hook Removal, Microscrew Internal Fixation and Plaster Fixation for the Treatment of Hamate Hook Fractures
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