Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy (CISKO)
Primary Purpose
Osteoarthritis, Varus Malalignment
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ellipse IM HTO Nail
TomoFix
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- North Cumbria University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ellipse IM HTO Nail
TomoFix
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Healing of the osteotomy site
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:
definition of osteotomy line,
osteotomy margin,
osteotomy gap,
callus appearances,
callus to cortex ratio,
bridging of the bone, including complete union and healing.
application of region of interest (ROI) to quantify bone density of the callus formation
Secondary Outcome Measures
Visual Analog Pain Scale
A patient reported outcome of their perception of pain
Osteotomy patient satisfaction questionnaire
A patient reported outcome of the patient's perception of satisfaction with treatment
SF-12 Quality of Life Questionnaire
A validated patient reported outcome.
KOOS Knee Health Questionnaire
A validated patient reported outcome.
Full Information
NCT ID
NCT03431662
First Posted
July 20, 2017
Last Updated
February 12, 2018
Sponsor
Ellipse Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03431662
Brief Title
Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy
Acronym
CISKO
Official Title
Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ellipse Technologies, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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-scan at 3 and 6-months postoperatively.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Varus Malalignment
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ellipse IM HTO Nail
Arm Type
Experimental
Arm Description
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.
Arm Title
TomoFix
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ellipse IM HTO Nail
Other Intervention Name(s)
Computerized Tomography (CT) Scan
Intervention Description
A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
Intervention Type
Procedure
Intervention Name(s)
TomoFix
Other Intervention Name(s)
Computerized Tomography (CT) Scan
Intervention Description
A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
Primary Outcome Measure Information:
Title
Healing of the osteotomy site
Description
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:
definition of osteotomy line,
osteotomy margin,
osteotomy gap,
callus appearances,
callus to cortex ratio,
bridging of the bone, including complete union and healing.
application of region of interest (ROI) to quantify bone density of the callus formation
Time Frame
6-month postoperative
Secondary Outcome Measure Information:
Title
Visual Analog Pain Scale
Description
A patient reported outcome of their perception of pain
Time Frame
6-month postoperative
Title
Osteotomy patient satisfaction questionnaire
Description
A patient reported outcome of the patient's perception of satisfaction with treatment
Time Frame
6-month postoperative
Title
SF-12 Quality of Life Questionnaire
Description
A validated patient reported outcome.
Time Frame
6-month postoperative
Title
KOOS Knee Health Questionnaire
Description
A validated patient reported outcome.
Time Frame
6-month postoperative
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
North Cumbria University Hospitals NHS Trust
City
Carlisle
ZIP/Postal Code
CA2 7HY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy
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