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

  • China
    • Hebei
      • 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 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.
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.
Other Names:
  • Techniques for Perilunate Dislocations
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.
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.
Other Names:
  • Techniques for Perilunate Dislocations

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.

Sponsor

The Second Hospital of Qinhuangdao

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

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

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

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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