Safety Study of Surgical Technique to Treat Acute Dorsal Trans-Scaphoid Perilunate Dislocations (ADTPD)
August 19, 2008 updated by: The Second Hospital of Qinhuangdao
Surgical Techniques for Acute Dorsal Trans-Scaphoid Perilunate Dislocations
The purpose of this study is to determine a surgical technique is effective in the treatment of acute dorsal trans-scaphoid perilunate dislocations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Open reduction and internal fixation is an effective method of treating acute trans-scaphoid perilunate dislocations.
We study a new surgical technique that allows for early wrist excises postoperatively.
We compare this technique to Inoue et al. 's techniques affect the objective and subjective outcomes.
We also compared the long-term outcomes of these two procedures performed in similar patient groups.Although both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture, the technique using in group I was more easily and quickly to perform.
It allows early postoperative excises and results better functional wrist range of motion.
Study Type
Interventional
Enrollment (Actual)
801
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
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-
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 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical treatment of acute trans-scaphoid perilunate dislocations
- Must have open reduction and internal fixation
Exclusion Criteria:
- Patients whose age under 18 years
- Associated with severe crush, avulsion, or opened injury
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Group I (treatment with our technique) Eighteen patients (18 wrists) were available for long-term follow-up at an average of 47.8 months after surgery.
There were 11 men and seven women.
Their mean age at the time of surgery was 35.4 years (range, 22 to 56 years).
The dominant hand was involved in 12 patients and the nondominant hand, in six.
|
Inoue et al.'s technique is most commonly used which required placing three K-wires to immobilize both midcarpal joint and radiocarpal joint.
This technique is effective, however, it has some problems.
In the study, we improve the surgical technique.
Other Names:
|
|
Experimental: 2
Group II (treatment with Inoue et al.'s technique) Fifteen patients (15 wrists) were evaluated at an average of 51 months.
Nine patients were men and 6 were women.
The mean age of the group at the time of surgery was 37.5 years (range, 24 to 58 years).
The dominant hand was involved in 10 and nondominant hand, in seven.
|
Inoue et al.'s technique is most commonly used which required placing three K-wires to immobilize both midcarpal joint and radiocarpal joint.
This technique is effective, however, it has some problems.
In the study, we improve the surgical technique.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
In group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion.
Time Frame: 1992-2004
|
1992-2004
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture.
Time Frame: 1992-2004
|
1992-2004
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xu Zhang, MD, 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
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
October 1, 1992
Primary Completion (Actual)
June 1, 2004
Study Completion (Actual)
October 1, 2004
Study Registration Dates
First Submitted
August 15, 2008
First Submitted That Met QC Criteria
August 19, 2008
First Posted (Estimate)
August 20, 2008
Study Record Updates
Last Update Posted (Estimate)
August 20, 2008
Last Update Submitted That Met QC Criteria
August 19, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHQ-0808-A
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