NCT00738127

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
801

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 1992

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1992

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
Last Updated

August 20, 2008

Status Verified

August 1, 2008

Enrollment Period

11.7 years

First QC Date

August 15, 2008

Last Update Submit

August 19, 2008

Conditions

Operative TimeGrip StrengthPainFunctional Status

Keywords

Acute trans-scaphoid perilunate dislocationsOpen reduction and internal fixationKirschner-wireRange of motion

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture.

    1992-2004

Study Arms (2)

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.

Procedure: Open reduction and internal fixation

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

Interventions

Open reduction and internal fixationPROCEDURE

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.

Also known as: Techniques for Perilunate Dislocations
12

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical treatment of acute trans-scaphoid perilunate dislocations
  • Must have open reduction and internal fixation

You may not qualify if:

  • Patients whose age under 18 years
  • Associated with severe crush, avulsion, or opened injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Qinhuangdao

Qinhuangdao, Hebei, 066600, China

Location

Related 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.

    PMID: 6386257BACKGROUND

Related Links

MeSH Terms

Conditions

Pain

Interventions

Open Fracture ReductionFracture Fixation, InternalMethods

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Xu Zhang, MD

    The Second Hospital of Qinhuangdao

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 20, 2008

Study Start

October 1, 1992

Primary Completion

June 1, 2004

Study Completion

October 1, 2004

Last Updated

August 20, 2008

Record last verified: 2008-08

Locations

CN(1)