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

Pain Clinical Trial

— ADTPD  

Official title:

Surgical Techniques for Acute Dorsal Trans-Scaphoid Perilunate Dislocations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738127
• Other study ID #: SHQ-0808-A
• Status: Completed
• Phase: N/A
• First received: August 15, 2008
• Last updated: August 19, 2008
• Start date: October 1992
• Est. completion date: October 2004

Study information

• Verified date: August 2008
• Source: The Second Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine a surgical technique is effective in the treatment of acute dorsal trans-scaphoid perilunate dislocations.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: October 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Functional Status
• Grip Strength
• Operative Time
• Pain

Intervention

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.

Locations

Country	Name	City	State
China	The Second Hospital of Qinhuangdao	Qinhuangdao	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

References & Publications (1)

Moneim MS, Hofammann KE 3rd, Omer GE. Transscaphoid perilunate fracture-dislocation. Result of open reduction and pin fixation. Clin Orthop Relat Res. 1984 Nov;(190):227-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion.		1992-2004	Yes
Secondary	Both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture.		1992-2004	Yes

External Links

•   Acute Dorsal Trans-scaphoid Perilunate Dislocations: Open Reduction and Internal Fixation
•   Perilunate Dislocations
•   Recurrent Dorsal Trans-Scaphoid Perilunate Dislocation
•   Trans-scaphoid perilunate fracture dislocations : Results of screw fixation of the scaphoid and lunotriquetral repair with a dorsal approach
•   Treatment of trans-scaphoid perilunate dislocations by internal fixation with the Herbert screw