No registrations found.
ID
Source
Brief title
Health condition
Malunited fracture of radius and/or ulna
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Postoperative improvement in forearm rotation
Secondary outcome
- Postoperative improvement in subjectively experienced limitations
- Postoperative reduction of pain
- Postoperative improvement of cosmetics
- Postoperative satisfaction
Background summary
Although a malunited fracture of (one of) the bones of the forearm can be disabling in terms of pain, loss of function and cosmetics, treatment is not yet sufficiently predictable. Patients are often young and their arm can not be fully used in daily life. In an earlier pilot study, we performed surgical correction of the fracture in 15 patients. Surgery was preoperatively planned using specially developed computer software. Also patient-specific drill and saw guides were used. The first results of this earlier study are very promising. All operated patients are satisfied with the result of the surgery. In the current study, we want to find out the added value of patient-specific guides above the virtual 3-dimensional planning.
Study objective
Our hypothesis is that we can achieve comparable clinical outcomes with accurate virtual 3D planning and surgical preparation only.
Study design
Baseline and 3, 6 and 12 months postoperative
Intervention
Corrective osteotomy of radius and/or ulna with or without the use of patient specific guides
Inclusion criteria
- Malunion after radius and/or ulna fracture
- Less than 50 degrees of pronation and/or supination
- Complaints of the forearm
- Age of at least 6 years
- Full consolidation of the fractures
- Informed consent for participation in the study
Exclusion criteria
- Relevant deviations of the contralateral arm
- Malunion of distal radius
- Insufficient understanding of the Dutch language
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8059 |
| Other | METC Erasmus MC : MEC-2019-0025 |