Back to resultsExploration of Wrist Soft Tissue Injuries Associated With Wrist Fractures
Primary Purpose
Triangular Fibrocartilage Complex Injuries
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Arthroscopy, surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Triangular Fibrocartilage Complex Injuries focused on measuring TFCC injuries, Distal radius fractures
Eligibility 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
Sites / Locations
- Dept of orthopedics
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Surgical exploration
Arm Description
Descriptive
Outcomes
Primary Outcome Measures
Residual instability symptoms
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01145716
Brief Title
Exploration of Wrist Soft Tissue Injuries Associated With Wrist Fractures
Official Title
Exploration of Acute TFCC-injuries in Association With Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Linkoeping University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triangular Fibrocartilage Complex Injuries
Keywords
TFCC injuries, Distal radius fractures
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical exploration
Arm Type
Other
Arm Description
Descriptive
Intervention Type
Procedure
Intervention Name(s)
Arthroscopy, surgery
Intervention Description
Ulno-volar wrist approach to the TFCC
Primary Outcome Measure Information:
Title
Residual instability symptoms
Description
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.
Time Frame
Approx 2-6 months to include the patients that meet the inclusion criteria. They will be followed for 6 momths
Secondary Outcome Measure Information:
Title
Adverse events
Description
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.
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars E Adolfsson, Assoc prof
Organizational Affiliation
Linkopeing University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of orthopedics
City
Linkoeping
ZIP/Postal Code
58185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
10906880
Citation
Lindau T, Hagberg L, Adlercreutz C, Jonsson K, Aspenberg P. Distal radioulnar instability is an independent worsening factor in distal radial fractures. Clin Orthop Relat Res. 2000 Jul;(376):229-35. doi: 10.1097/00003086-200007000-00031.
Results Reference
background
PubMed Identifier
9752922
Citation
Lindau T, Arner M, Hagberg L. Intraarticular lesions in distal fractures of the radius in young adults. A descriptive arthroscopic study in 50 patients. J Hand Surg Br. 1997 Oct;22(5):638-43. doi: 10.1016/s0266-7681(97)80364-6.
Results Reference
background
PubMed Identifier
8641057
Citation
Geissler WB, Fernandez DL, Lamey DM. Distal radioulnar joint injuries associated with fractures of the distal radius. Clin Orthop Relat Res. 1996 Jun;(327):135-46. doi: 10.1097/00003086-199606000-00018.
Results Reference
background
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Exploration of Wrist Soft Tissue Injuries Associated With Wrist Fractures
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