The primary research question includes: Can ESWT induce fracture healing in non-healing AFF's after six months?
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of healed AFF's after six months assessed with CT-scan.
Secondary outcome
Number of healed AFF's after 3 monts, changes in patient reported outcome
measures at 3 and 6 month compared to baseline.
Background summary
Patients with atypical femur fractures are usually treated surgically with an
intramedullary nail. However, due to poor bone quality, AFF's often experience
problems with consolidation.A non-healing AFF is a highly disabling condition
for which no effective treatment does exist. Application of extracorporeal
shock wave therapy (ESWT) is a very potent non-invasive therapy for bone
regeneration because is stimulates early angiogenesis and subsequent
osetogenesis. ESWT is an effective treatment in non-healing fractures and could
therefore be an effective treatment for non-healing AFF's as well.
Study objective
The primary research question includes: Can ESWT induce fracture healing in
non-healing AFF's after six months?
Study design
Pilot-study
Intervention
Patients participating in the study will be treated with ESWT twice, at a two
week interval. Patients will be treated at our day care facility under local or
general anesthesia. During one treatment of ESWT 4000 shocks will be applied at
an energy density level of 0.59 mJ/mm2, which will take about 30 minutes.
Study burden and risks
ESWT is used worldwide for treatment of orthopedic disorders, including
treatment of non-healing fractures. In the current study the same treatment
protocol is used as in treatment for non-unions of long bones. Besides local
reddening and ecchymosis no other side effects have been found.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- AFF according to the American Society for Bone and Mineral Research Task
Force created guidelines
- Time since primary surgical fixation of the AFF more than > 1 year
- Fracture gap <5 mm
- Good understanding of the Dutch language and willing to participate
- 18 years or older
Exclusion criteria
- Instable or displaced AFF
- Active infection
- Haemophilia
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 | NL69232.078.19 |