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Exploration of Wrist Soft Tissue Injuries Associated With Wrist Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01145716
First Posted: June 17, 2010
Last Update Posted: May 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Linkoeping University
  Purpose
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.

Condition Intervention
Triangular Fibrocartilage Complex Injuries Procedure: Arthroscopy, surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exploration of Acute TFCC-injuries in Association With Distal Radius Fractures

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: August 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgical exploration
Descriptive
Procedure: Arthroscopy, surgery
Ulno-volar wrist approach to the TFCC

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145716


Locations
Sweden
Dept of orthopedics
Linkoeping, Sweden, 58185
Sponsors and Collaborators
Linkoeping University
Investigators
Principal Investigator: Lars E Adolfsson, Assoc prof Linkopeing University, Sweden
  More Information

Publications:
Responsible Party: Johan Scheer MD, County Council of Ostergotland
ClinicalTrials.gov Identifier: NCT01145716     History of Changes
Other Study ID Numbers: OC Linkoping TFCC volar expl
Dnr M200-08 Linkoping ( Other Identifier: Linkoeping University/County Council Ostergotland )
First Submitted: May 4, 2010
First Posted: June 17, 2010
Last Update Posted: May 20, 2011
Last Verified: November 2009

Keywords provided by Linkoeping University:
TFCC injuries
Distal radius fractures

Additional relevant MeSH terms:
Wounds and Injuries
Radius Fractures
Forearm Injuries
Arm Injuries
Fractures, Bone