Distal Radius Fractures
Conditions
Keywords
Locking Compression Plate, Conservative treatment, Surgical treatment, Radius fractures, AO 23
Brief summary
Primary objective of the study is to demonstrate specific indications for the surgical treatment of distal radius fractures using the locking compression plate.
Detailed description
In addition the differences between the surgical treatment compared to conservative treatment with respect to fracture healing, functional outcome and subject satisfaction will be analysed after 6w./6m./1y./2y.
Interventions
DEVICELocking Compression Plate 2,4mm
DEVICELocking Compression Plate 3,5mm
Sponsors
Synthes Inc.
AO Hand Expert Group
AO Clinical Investigation and Publishing Documentation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* skeletally mature female and male * Distal radius and ulnar fractures AO 23 * 10 days after injury
Exclusion criteria
* general or local conditions adversely affecting the bone physiology * ISS \>16 * osteosynthesis close to the wrist joint where a different implant has been used * history of drug and alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Document specific indications for the surgical treatment of distal radius fractures using the LCP | — |
Secondary
| Measure | Time frame |
|---|---|
| - Primary reduction and maintenance of reduction of the plate fixation | — |
| - Functional outcome scoring using Garetland and Werley, DASH and SF-36 scoring | — |
| - Patient and surgeon satisfaction | — |
| - Analysis of the occured complications | — |
Countries
Germany, United Kingdom, United States
Outcome results
None listed