The aim of this study is to provide an overview of this novel technique and to present the preliminary clinical results in a series of patients.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative residual deformation evaluated using CT scans
Secondary outcome
Wrist function as measured on the DASH score and PRWE score, pain, prehensile
gripstrength, Range of Motion, patient satisfaction.
Background summary
Corrective osteotomy for patients with a malunited radius fracture may improve
wrist function and reduce other symptoms such as pain. Since functional outcome
is susceptible to the accurateness of the anatomic reconstruction, detailled
preoperative planning is essential. However, malunions often involve complex
deformations which are not recognized during conventional preoperative
planning. Computer-assisted navigation techniques with 3D images address
three-dimensional deformity and may optimise functional and radiological
results of corrective osteotomies of the radius.
Study objective
The aim of this study is to provide an overview of this novel technique and to
present the preliminary clinical results in a series of patients.
Study design
A prospective observational follow up study which will be conducted in the
Academic Medical Center Amsterdam for an estimated period of six months.
Study burden and risks
Patients will be asked to return to the hospital once. During this visit
patients will be asked about any complaints/pain/contentment. These procedures
are all part of standard care. The two questionnaires (DASH and PRWE) provide a
tool to assess wrist function in a validated and standardized manner and will
take an estimated 10 minutes each. Physical examination of the wrist including
range of motion and prehensile grip strength are also part of standard follow
up. A post operative CT scan provides information on the position of the bone
and osteosynthesis material, fracture healing and residual deformation. The
radiation exposure is minimal (0.6mSV), however, this examination is also often
part of usual care.
For this study, patients will be asked to return to the hospital for follow up
only once. The risks are comparable to those that the standard follow up visits
involve. The burden experienced regarding time spent will not exceed 50
minutes.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1. Patients with a symptomatic malunion of a distal radius or midshaft fracture which was treated with a computer-assisted planned osteotomy
Exclusion criteria
1. Not able to understand the written informed consent
2. Pregnant
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42760.018.12 |