Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy
NCT ID: NCT03431662
Last Updated: 2018-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2016-03-31
2017-03-31
Brief Summary
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Detailed Description
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HTO involves cutting a wedge out the tibia to correct the alignment of that bone with the knee joint, to redistribute load from the affected medial part to lateral part. To keep the tibia in the new position, a medical nail device is attached to keep it in place and allow new bone to regenerate within the wedge. Currently, the market leader for HTO is the TomoFix (by DePuySynthes company) plate and nail device. As the name suggests, TomoFix is fixed at surgery and therefore the change in bone angle cannot be changed afterwards. It does mean that patients can be weight-bearing on the affected leg soon after the HTO procedure. A new CE-marked device is being tested in an interventional trial; it is produced by Ellipse Technologies. This device is an extendable nail and inserted intramedullary; following surgery the nail is tend slowly extended over a period of time until the bone correction is satisfactory.
The CISKO imaging study will assess whether there is a difference between the TomoFix and Ellipse system in terms of bone regeneration in the tibial wedge by performing a CT-scan at 3 and 6 months post-operatively. This will be quantified by two independent radiological reports. A secondary objective is to investigate patient satisfaction and also patient pain levels at these time intervals. The degree of bone healing is usually the main factor holding clinicians back when it comes to advising patients on what activities they can return to post-operatively. A difference in bone healing between the two systems may impact on the advice clinicians can give patients regarding recommencing more intense activities such as recreational sports, which ultimately could positively impact patients' health and well-being.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Ellipse IM HTO Nail
In this arm, the subjects varus malalignment is corrected with Ellipse Intramedullary High Tibial Osteotomy Intramedullary Nail, which is a CE device. The device achieves the correction via progressive distraction osteogenesis.
Ellipse IM HTO Nail
A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
TomoFix
In this arm, the subjects varus malalignment is corrected with Synthes TomoFix system, which is a CE device. The device achieves the correction via fixating an accute intraoperative correction of the varus malalignment.
TomoFix
A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
Interventions
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Ellipse IM HTO Nail
A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
TomoFix
A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Provision of written informed consent
3. Males
4. Mental capacity
Exclusion Criteria
2. Patients lacking mental capacity.
3. Females
4. Current use of nicotine products.
5. Patients who cannot understand English and therefore cannot be consented.
18 Years
MALE
No
Sponsors
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Ellipse Technologies, Inc.
INDUSTRY
Responsible Party
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Locations
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North Cumbria University Hospitals NHS Trust
Carlisle, , United Kingdom
Countries
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Other Identifiers
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PR0251
Identifier Type: -
Identifier Source: org_study_id
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