Triangular Fibrocartilage Complex Injuries Clinical Trial
Official title:
Exploration of Acute TFCC-injuries in Association With Distal Radius Fractures
| Verified date | November 2009 |
| Source | Linkoeping University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: The National Board of Health and Welfare |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | May 2011 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Dept of orthopedics | Linkoeping |
| Lead Sponsor | Collaborator |
|---|---|
| Linkoeping University |
Sweden,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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. | Three months | Yes |