- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01479738
Proximal Interphalangeal Joint Arthroplasty Using a Graft From the Capitate (PIPPC)
November 24, 2011 updated by: The Second Hospital of Qinhuangdao
The Second Hospital of Qinhuangdao, Qinhuangdao, Hebei, 066600, China
The capitate had a widened distal base.
The distal articulation can be used for proximal interphalangeal (PIP) articula reconstruction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Previous anatomical studies have shown that the capitate had a widened distal base.
The distal articulation was mainly with the base of the third metacarpal and partially with the base of the second metacarpal.
The articulation was slightly flattened with a convex and concave dorsal articular surface.
The contour stimulates our imagination and creativity to use a portion of the articular surface for PIP arthroplasty.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hebei
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Qinhuangdao, Hebei, China, 066600
- The Second Hospital of Qinhuangdao
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- an articular defect at the proximal aspect of the PIP joint;
- the defect larger than 5 mm × 5 mm in size based on intraoperative findings.
Exclusion Criteria:
- large defects involved double joint surfaces;
- the size of the defect less than 5 mm × 5 mm;
- mult-digital articular defects that all required osteoarticular grafting;
- associate with infection or other diseases that restrict to use the technique.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Capitate bone grafting
18 patients with PIP joint defects were included in the study.
There were 13 male and 5 female patients with a mean age of 31 years (range, 18-47 years).
The injury occurred in the right hand in 11 patients and on the left hand in 7. The injured PIP joints were in the index finger (n=7), long finger (n=9), and ring finger (n=2).
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Capitate bone graft transfer for PIP joint reconstruction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
range of motion
Time Frame: 37 to 46 months postoperatively
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Active range of motion of the hand were measured by a goniometer.
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37 to 46 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
grip strength
Time Frame: 37 to 46 months postoperatively
|
The grip strength of the thumb to the injured finger was measured using dynamometers
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37 to 46 months postoperatively
|
pinch strength
Time Frame: 37 to 46 months postoperatively
|
The pinch strength of the thumb to the injured finger was measured using dynamometers
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37 to 46 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xu Zhang, M.D., The Second Hospital of Qinhuangdao
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
November 19, 2011
First Submitted That Met QC Criteria
November 22, 2011
First Posted (Estimate)
November 24, 2011
Study Record Updates
Last Update Posted (Estimate)
November 28, 2011
Last Update Submitted That Met QC Criteria
November 24, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHQ002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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