Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
Recruiting
Observational Study
Leg Length Inequality
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 12 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 45 (estimated)
- Sponsor
- Orthofix s.r.l. · Industry
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About This Trial
This study is a prospective observational non-interventional multi-centre cohort study of patients, 12 years or older, initiating a lower limb lengthening procedure with FITBONE and who have a length discrepancy of 30mm or more between the limbs.
The following parameters will be assessed for up to 24 months.
* Pain using the Visual Analog Scale (VAS), Patient Global Assessment (PGA) and Clinical…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients aged ≥12 years old, with congenital or acquired lower limb discrepancy greater than 30mm, undergoing femoral or tibia bone lengthening with FITBONE
* Patients with a regular indication for a surgical intervention with FITBONE according to manufacturer IFU
* The patien…
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