The aim of this study is to increase the predictability of these difficult procedures which hopefully result in less pain in combination with better function and cosmetics.Objectives: Accuracy of corrective osteotomyDoes a corrective osteotomy…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The aim of this study is to increase the predictability of these difficult
procedures which hopefully result in less pain in combination with better
function and cosmetics.
primary outcome:
Improvement of pronation and supination postoperatively.
Secondary outcome
secundary outcomes:
* Reduced pain postoperatively (VAS score).
* Better cosmetics postoperatively (VAS score).
* Relation between radiological and clinical outcomes.
* Accuracy of MRI as a tool of preplanning a corrective osteotomy.
* MRI preoperatively to find soft tissue scars
* Accuracy of *true angulation* on X-ray compared to CT
Background summary
Both-bone forearm fractures are common in children. Displaced fractures need to
be reduced and all fractures need to be stabilized with pins and/or cast. In 30
percent of children treated in cast secondary fracture displacement occur. This
fracture displacement might result in malunited fractures with complaints of
pain, limitation of function and cosmetics.
The treatment of a symptomatic malunited forearm fracture consists of a
corrective osteotomy. These corrective osteotomies are very difficult to plan
and operate and therefore few (orthopedic) surgeon do these procedures.
In this study, preoperative 3-dimensional planning of the corrective osteotomy
is based on the mirrored normal anatomy of the non-fractured forearm and
results in silicon mals which are used during surgery.
Study objective
The aim of this study is to increase the predictability of these difficult
procedures which hopefully result in less pain in combination with better
function and cosmetics.
Objectives:
Accuracy of corrective osteotomy
Does a corrective osteotomy result in less pain, better function and better
cosmetics?
Study design
Inclusion of patients with a symptomatic malunited forearm fractures in which
consersative treatment failed.
preoperative and 6 months and 1 year postoperative:
- Promis itembank lichamelijk functioneren bij kinderen - bovenste extremiteit
- Abilhand kids score
- Quick DASH score
- Painscore: VAS
- Cosmetic: VAS.
preoperative and 6 months and 1 year postoperative:
function of arm: flexion and extension of wrist and elbow, ulnar en radial
deviation wrist, pronation and supination
DRUJ stability test
sqeeuze-test with Jamar Hydraulic Hand Dynamometer.
radiology
conventional X-rays pre- and postoperatively
CT-scan of both forearms preoperatively and 1 year postoperatively.
MRI-scan of both forearm preoperatively
Intervention
corrective osteotomy
Study burden and risks
CT-scan of both forearms postoperative extra (0.2mSv (Sievert)
It takes time for the patient (questionnairres, MRI, examination)
benefit: shorter surgical time, better accuracy of corrective osteotomies and
better function and cosmetics of the traumatized forearm.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
malunited both-bone forearm fractures with complaints of pain and/or limitation of forearm rotation.
Exclusion criteria
no pain or limitation of forearm rotation
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 | NL52987.078.15 |