Status:
COMPLETED
Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy
Lead Sponsor:
Ellipse Technologies, Inc.
Conditions:
Osteoarthritis
Varus Malalignment
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess whether there is a difference between the TomoFix and Ellipse Intramedullary HTO Nail System in terms of bone regeneration in the tibial wedge by performing a CT...
Detailed Description
Malalignment of the knee joint causes arthritis in later life. Currently there are three surgical ways to treat knee arthritis: total knee replacement, partial knee replacement, and high tibial osteot...
Eligibility Criteria
Inclusion
- Indicated treatment with medial open wedge proximal tibial osteotomy, either with Tomofix device or Ellipse device
- Provision of written informed consent
- Males
- Mental capacity
Exclusion
- Under age (\< 18 years)
- Patients lacking mental capacity.
- Females
- Current use of nicotine products.
- Patients who cannot understand English and therefore cannot be consented.
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03431662
Start Date
March 1 2016
End Date
March 1 2017
Last Update
February 13 2018
Active Locations (1)
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1
North Cumbria University Hospitals NHS Trust
Carlisle, United Kingdom, CA2 7HY