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| Sponsored by: |
The Second Hospital of Qinhuangdao |
|---|---|
| Information provided by: | The Second Hospital of Qinhuangdao |
| ClinicalTrials.gov Identifier: | NCT00738127 |
Purpose
The purpose of this study is to determine a surgical technique is effective in the treatment of acute dorsal trans-scaphoid perilunate dislocations.
| Condition | Intervention |
|---|---|
|
Operative Time Grip Strength Pain Functional Status |
Procedure: Open reduction and internal fixation |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Surgical Techniques for Acute Dorsal Trans-Scaphoid Perilunate Dislocations |
| Enrollment: | 801 |
| Study Start Date: | October 1992 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
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Procedure: Open reduction and internal fixation
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.
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2: Experimental
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.
|
Procedure: Open reduction and internal fixation
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China, Hebei | |
| The Second Hospital of Qinhuangdao | |
| Qinhuangdao, Hebei, China, 066600 | |
| Study Chair: | Xu Zhang, MD | The Second Hospital of Qinhuangdao |
More Information
| Responsible Party: | The Second Hospital of Qinhuangdao ( Xu Zhang / MD ) |
| Study ID Numbers: | SHQ-0808-A |
| Study First Received: | August 15, 2008 |
| Last Updated: | August 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00738127 History of Changes |
| Health Authority: | China: Ethics Committee |
|
Acute trans-scaphoid perilunate dislocations Open reduction and internal fixation Kirschner-wire Range of motion |
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Dislocations Wounds and Injuries Influenza, Human Disorders of Environmental Origin Pain |
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Dislocations Wounds and Injuries Disorders of Environmental Origin |
