Exploration of Wrist Soft Tissue Injuries Associated With Wrist Fractures

May 19, 2011 updated by: Linkoeping University

Exploration of Acute TFCC-injuries in Association With Distal Radius Fractures

The purpose of this study is to describe and stage lesions of the triangular fibrocartilage complex (TFCC) in association with distal radius fractures. 20 patients with dorsally dislocated AO type A fractures of the distal radius with sufficient displacement (based of cadaveric data) will be included. After stability testing and wrist arthroscopy. The TFCC is explored through a volar incision and injuries were documented and repaired from this approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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

  • Sweden
      • Linkoeping, Sweden, 58185
        • Dept of orthopedics

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-65
  • Distal radius fracture
  • Displacement > 20 degrees of dorsal angulation

Exclusion Criteria:

  • Previous significant wrist injury
  • Declines to participate
  • Ulnar styloid fracture at base or proximal to it

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surgical exploration
Descriptive
Procedure: Arthroscopy, surgery
Ulno-volar wrist approach to the TFCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual instability symptoms
Time Frame: Approx 2-6 months to include the patients that meet the inclusion criteria. They will be followed for 6 momths
Mechanisms of injury are poorly previously described. This study will hopefully confirm cadeveric data. There is some evidence that patients might benefit from acute repair. Residual instability can be both ulnocarpal and radioulnar.
Approx 2-6 months to include the patients that meet the inclusion criteria. They will be followed for 6 momths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Three months
Patients that accept to participate will undergo exploration from a (new) ulnovolar approach. The study is purely descriptive. Patients are monitored for adverse events such as nerve injury and infection for 3 months.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Investigators

  • Principal Investigator: Lars E Adolfsson, Assoc prof, Linkopeing University, Sweden

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

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

August 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Estimate)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC Linkoping TFCC volar expl
  • Dnr M200-08 Linkoping (Other Identifier: Linkoeping University/County Council Ostergotland)

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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