NCT01145716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 20, 2011

Status Verified

November 1, 2009

Enrollment Period

1.7 years

First QC Date

May 4, 2010

Last Update Submit

May 19, 2011

Conditions

Keywords

TFCC injuriesDistal radius fractures

Outcome Measures

Primary Outcomes (1)

  • 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.

    Approx 2-6 months to include the patients that meet the inclusion criteria. They will be followed for 6 momths

Secondary Outcomes (1)

  • Adverse events

    Three months

Study Arms (1)

Surgical exploration

OTHER

Descriptive

Procedure: Arthroscopy, surgery

Interventions

Ulno-volar wrist approach to the TFCC

Surgical exploration

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of orthopedics

Linköping, 58185, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 10906880BACKGROUND
  • 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.

    PMID: 9752922BACKGROUND
  • 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.

    PMID: 8641057BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Interventions

ArthroscopySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresOrthopedic Procedures

Study Officials

  • Lars E Adolfsson, Assoc prof

    Linkopeing University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 4, 2010

First Posted

June 17, 2010

Study Start

August 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 20, 2011

Record last verified: 2009-11

Locations