Bone Malalignment Clinical Trial
— CISKOOfficial title:
Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy [CT Imaging Study for Knee Osteotomy (CISKO)]
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | February 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: 1. Provision of written informed consent 2. Males 3. Mental capacity Exclusion Criteria: 1. Under age (< 18 years) 2. Patients lacking mental capacity. 3. Females 4. Current use of nicotine products. 5. Patients who cannot understand English and therefore cannot be consented. Pre-existing clinical exclusion criteria (for both Ellipse and Tomofix patients): 1. Varus deformity greater than 10° 2. Flexion contracture greater than 15° 3. Knee flexion under 90° 4. Medial/lateral tibial subluxation over 1 cm 5. Medial bone loss of over 3 mm 6. Inflammatory arthritis (including use of methotrexate) 7. Arthritis in the lateral compartment 8. Patella baja 9. Weight over 114 kg 10. Severe patella femoral symptoms 11. Unaddressed ligamentous instability 12. Fixed flexion contracture 13. Known or suspected osteoporosis or osteopenia based on medical history and radiographic image 14. Requires other surgical procedures at the time of the HTO surgery - |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cumberland Infirmary | Carlisle | Cumbria |
Lead Sponsor | Collaborator |
---|---|
North Cumbria University Hospitals NHS Trust | NuVasive |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Healing score | Healing of the osteotomy site after final correction as assessed by two independent radiology reports based on visual assessment of the CT imaging | 3 months | No |
Secondary | Patient satisfaction score | Patients' perspective of the degree of healing and rehabilitation following high tibial osteotomy | 6 months | No |
Secondary | Change in KOOS score | difference in KOOS score , comparing per-operative vs 6 months post-operative. | 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03835000 -
Customized Biomechanical Models of the Musculoskeletal System Before and After Surgery
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