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Completed

NCT Number: NCT01145716

Exploration of Wrist Soft Tissue Injuries Associated With Wrist 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.

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Key information

Conditions

Triangular Fibrocartilage Complex Injuries Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of orthopedics

Linköping, 58185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopy, surgery

Procedure

Ulno-volar wrist approach to the TFCC

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2010
Registry last updated
May 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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