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Treating non-healing atypical femur fractures (AFF) with extracorporeal shock wave therapy (ESWT); a pilot-study.

Treating non-healing atypical femur fractures (AFF) with extracorporeal shock wave therapy (ESWT); a pilot-study. - ESWT for non-healing AFF

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48267
Enrollment
10
Registered
2019-10-30
Start date
2019-12-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

atypical femur fracture

Interventions

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

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Instable or displaced AFF - Active infection - Haemophilia

Design outcomes

Primary

MeasureTime frame
Number of healed AFF's after six months assessed with CT-scan.

Secondary

MeasureTime frame
Number of healed AFF's after 3 monts, changes in patient reported outcome measures at 3 and 6 month compared to baseline.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)