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Safety Study of Surgical Technique to Treat Acute Dorsal Trans-Scaphoid Perilunate Dislocations (ADTPD)

This study has been completed.
Sponsor:
Information provided by:
The Second Hospital of Qinhuangdao
ClinicalTrials.gov Identifier:
NCT00738127
First received: August 15, 2008
Last updated: August 19, 2008
Last verified: August 2008
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Surgical Techniques for Acute Dorsal Trans-Scaphoid Perilunate Dislocations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Second Hospital of Qinhuangdao:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture. [ Time Frame: 1992-2004 ] [ Designated as safety issue: Yes ]

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
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 Name: 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 Name: Techniques for Perilunate Dislocations

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738127

Locations
China, Hebei
The Second Hospital of Qinhuangdao
Qinhuangdao, Hebei, China, 066600
Sponsors and Collaborators
The Second Hospital of Qinhuangdao
Investigators
Study Chair: Xu Zhang, MD The Second Hospital of Qinhuangdao
  More Information

Additional Information:
Treatment of trans-scaphoid perilunate dislocations by internal fixation with the Herbert screw  This link exits the ClinicalTrials.gov site
Recurrent Dorsal Trans-Scaphoid Perilunate Dislocation  This link exits the ClinicalTrials.gov site
Perilunate Dislocations  This link exits the ClinicalTrials.gov site
Trans-scaphoid perilunate fracture dislocations : Results of screw fixation of the scaphoid and lunotriquetral repair with a dorsal approach  This link exits the ClinicalTrials.gov site
Acute Dorsal Trans-scaphoid Perilunate Dislocations: Open Reduction and Internal Fixation  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Xu Zhang / MD, The Second Hospital of Qinhuangdao
ClinicalTrials.gov Identifier: NCT00738127     History of Changes
Other Study ID Numbers: SHQ-0808-A
Study First Received: August 15, 2008
Last Updated: August 19, 2008
Health Authority: China: Ethics Committee

Keywords provided by The Second Hospital of Qinhuangdao:
Acute trans-scaphoid perilunate dislocations
Open reduction and internal fixation
Kirschner-wire
Range of motion

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013