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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Page 1 of 1 (1 locations)

1

North Cumbria University Hospitals NHS Trust

Carlisle, United Kingdom, CA2 7HY