Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy (CISKO)
Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge
Study Overview
Status
Conditions
Intervention / Treatment
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 osteotomy (HTO). The former two very much focus on treating the effect of malalignment, i.e. removing the arthritic joint. However, HTO addresses the cause of the arthritis, namely the joint malalignment. This preserves the patient's joint and it means that a patient will start using the unaffected part of the knee joint more.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Carlisle, United Kingdom, CA2 7HY
- North Cumbria University Hospitals NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: 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.
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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 Names:
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ACTIVE_COMPARATOR: 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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Healing of the osteotomy site
Time Frame: 6-month postoperative
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Healing of the osteotomy site after final correction as assessed by two independent radiology reports based on visual assessment of the CT imaging. The scoring system is derived from a study by Brosset and colleagues (Brosset et al, 2011). In addition to a pure clinician perspective of the healing process, CT imaging data will also be used to quantify and describe:
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6-month postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analog Pain Scale
Time Frame: 6-month postoperative
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A patient reported outcome of their perception of pain
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6-month postoperative
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Osteotomy patient satisfaction questionnaire
Time Frame: 6-month postoperative
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A patient reported outcome of the patient's perception of satisfaction with treatment
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6-month postoperative
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SF-12 Quality of Life Questionnaire
Time Frame: 6-month postoperative
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A validated patient reported outcome.
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6-month postoperative
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KOOS Knee Health Questionnaire
Time Frame: 6-month postoperative
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A validated patient reported outcome.
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6-month postoperative
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR0251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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