With this study we try to answer the following question:What is the clinical outcome after a corrective osteotomy of a forearm malunion when we virtually plan the correction preoperatively and whether or not use patient-specific guides…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Postoperative improvement in pronation and supination.
Secondary outcome
• Possibility to use boneMRI for the planning of the osteotomy.
• Postoperative improvement in subjectively experienced limitations.
• Postoperative reduction of pain.
• Postoperative improvement of cosmetics.
• Postoperative satisfaction.
• Usefulness of preoperative MRI for imaging of soft tissue scarring.
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
With this study we try to answer the following question:
What is the clinical outcome after a corrective osteotomy of a forearm malunion
when we virtually plan the correction preoperatively and whether or not use
patient-specific guides peroperatively?
Study design
A randomized controlled pilot study with a one year follow-up.
Intervention
Corrective osteotomy of radius and/or ulna.
Study burden and risks
Patients will have the standard risks associated with surgery. They will also
have radiation exposure from the X-rays (pre- and postoperative) and the CT
scan (preoperative).
The extra load for patients participating in the study in comparison to
patients not participating are:
- An additional CT scan 1 year postoperatively (extra radiation 0.4 mSv).
- Time load for filling in questionnaires at 4 time moments and extensive
physical examination.
- An MRI scan is usually not made preoperatively.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
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 | NL68650.078.19 |