Osteochondral defect, Osteochondral lesion, Ankle, Talus, Arthroscopy Osteochondraal defect, Osteochondritis dissecans, Enkel, Talus, Artroscopie
Conditions
Interventions
In both groups the investigational treatment (active PEMF-treatment or sham device treatment) will start three days after surgery. It will be applied four hours daily (in one or two sessions) for a pe
Sponsors
Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a symptomatic OD of the talus who are scheduled for arthroscopic debridement and microfracture; 2. OD diameter = 4 before symptoms; 4. Age 18 years or older.
Exclusion criteria
Exclusion criteria: 1. Concomitant OD of the tibia; 2. Ankle osteoarthritis grade 2 or 3; 3. Ankle fracture < 6 months before scheduled arthroscopy; 4. Surgical treatment of the index ankle performed < 1 year before scheduled arthroscopy; 5. Concomitant painful or disabling disease of the lower limb; 6. Rheumatoid arthritis; 7. Pregnancy; 8. Implanted pacemaker; 9. Participation in concurrent trials; 10. Participation in previous trials < 1 year, in which the subject has been exposed to radiation (radiographs or CT); 11. Patients who are unable to fill out questionnaires and cannot have them filled out; 12. No informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The combined primary outcome measures are: 1. The number of patients that resume and maintain sports during 12 months follow-up; 2. The time to resumption of sports, defined by the AAS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to resumption of work; 2. American Orthopaedic Foot and Ankle Society - Ankle and Hindfoot clinical rating System (AOFAS-AHS); 3. Foot and Ankle Outcome Score (FAOS); 4. Quality of life (EuroQol); 5. Pain; 6. Satisfaction; 7. Computed tomography evaluation; 8. Adverse events. | — |
Contacts
Public ContactC.J.A. Bergen, van
Outcome results
None listed