To achieve earlier sport resumption in more patients due to PEMFs compared to placebo.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Combination of timing of resumption of sports (weeks after surgery) and number
of patients that resume sports.
Secondary outcome
work resumption
AOFAS-AHS: American Orthopaedic Foot and Ankle Society - Ankle Hindfoot Scale
FAOS: Foot and Ankle Outcome Score
quality of life (EQ-5D)
pain and satisfaction on a Visual Analogue Scale
bone regeneration on CT
Side-effects
Background summary
Pulsed Electromagnetic Fields (PEMF) haven been used since three decades. In
animal research the effect on cartilage and bone regeneration has been proven.
Clinically, however, the only entities on which an effect is objectified is
delayed union or nonunion of bone fractures and knee arthroscopy; clinical
results of PEMF as a solitary treatment for osteoarthritis are conflicting in
different studies. In view of the working mechanism of PEMF we expect a
positive effective of the treatment on osteochondral ankle defects after
arthroscopic treatment.
Study objective
To achieve earlier sport resumption in more patients due to PEMFs compared to
placebo.
Study design
A double-blind, randomized, placebo controlled multicenter trial
Intervention
During 60 days after surgery patients will receive a device around the ankle (4
hrs/d) which produces electromagnetic fields or sham device.
Study burden and risks
In former studies with PEMF no serious side-effects have been reported. The
treatment will take place in a similar manner (frequency and duration) as in
one of these studies. If a complaint or side-effect should occur, participating
patients will have the opportunity to stop with the study at all times.
The treatment with PEMFs is noninvasive and is relatively simple to implement
in the rehabilitation period of the current standard treatment of osteochondral
defects. Patients will not feel the electromagnetic fields, nor will they hear
the device, and the risk of side-effects is minimal. There will be no extra
visits to the hospital. However, the visits will be longer than usual because
of the assessment of research outcome (max. 30 min). Next to this, the patients
will be contacted by telephone twice. The additional CT-scan involves exposure
to radiation.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. Patients with a symptomatic osteochondral defects of the talus who are scheduled for arthroscopic debridement and microfracturing.
2. diameter < 15 mm
3. active sporters (ankle activity score > 3)
4. 18 years or older
Exclusion criteria
Concomitant osteochondral defect of the tibia
Ankle osteoarthritis grade 2 or 3
Ankle fracture < 6 months before scheduled arthroscopy
Surgical treatment of the index ankle performed < 1 year before scheduled arthroscopy
Concomitant painful or disabling disease of the lower limb
Rheumatoid arthritis
Pregnancy
Implanted pacemaker
Participation in concurrent trials
Participation in previous trials < 1 year, in which the subject has been exposed to radiation (radiographs or CT)
Patients who are unable to fill out questionnaires and cannot have them filled out
No informed consent
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 | NL19129.018.08 |