Text Size

Exploration of Wrist Soft Tissue Injuries Associated With Wrist Fractures

This study has been completed.
Sponsor:
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT01145716
First received: May 4, 2010
Last updated: May 19, 2011
Last verified: November 2009
History of Changes
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Exploration of Acute TFCC-injuries in Association With Distal Radius Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 4, 2010
Last Updated: May 19, 2011
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Linkoeping University:
TFCC injuries
Distal radius fractures

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

ClinicalTrials.gov processed this record on May 23, 2013