Pulsed Electromagnetic Fields after Arthroscopic Treatment for Osteochondral Defects of the Talus: Double-blind Randomized Controlled Multicenter Trial

Pulsed Electromagnetic Fields after Arthroscopic Treatment for Osteochondral Defects of the Talus: Double-blind Randomized Controlled Multicenter Trial - PEMF-trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31683

Enrollment

Registered

2008-12-12

Start date

2009-01-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bone and cartilage defect osteochondral defect

Interventions

During 60 days after surgery patients will receive a device around the ankle (4 hrs/d) which produces electromagnetic fields or sham device.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with a symptomatic osteochondral defects of the talus who are scheduled for arthroscopic debridement and microfracturing. 2. diameter 3) 4. 18 years or older

Exclusion criteria

Exclusion criteria: Concomitant osteochondral defect of the tibia Ankle osteoarthritis grade 2 or 3 Ankle fracture

Design outcomes

Primary

Measure	Time frame
Combination of timing of resumption of sports (weeks after surgery) and number of patients that resume sports.	—

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)