CompletedNot Applicable

Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy

United Kingdom12 participantsStarted 2016-03

Plain-language 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-scan at 3 and 6-months postoperatively.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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 criteria

✕. Under age (\< 18 years)
✕. Patients lacking mental capacity.
✕. Females
✕. Current use of nicotine products.
✕. Patients who cannot understand English and therefore cannot be consented.

What they're measuring

Healing of the osteotomy site

Timeframe: 6-month postoperative

Trial details

NCT IDNCT03431662

SponsorEllipse Technologies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03

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