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CT Imaging Study for Knee Osteotomy (CISKO) (CISKO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717845
Recruitment Status : Unknown
Verified April 2016 by North Cumbria University Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : March 24, 2016
Last Update Posted : April 8, 2016
Sponsor:
Collaborator:
NuVasive
Information provided by (Responsible Party):
North Cumbria University Hospitals NHS Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bone Malalignment Device: Ellipse Device: Tomofix Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy [CT Imaging Study for Knee Osteotomy (CISKO)]
Study Start Date : March 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CT scan Ellipse
New medical device for high tibial osteotomy
Device: Ellipse
diagnostic CT scan imaging

Active Comparator: CT scan Tomofix
Established medical device for high tibial osteotomy
Device: Tomofix
diagnostic CT scan imaging




Primary Outcome Measures :
  1. Healing score [ Time Frame: 3 months ]
    Healing of the osteotomy site after final correction as assessed by two independent radiology reports based on visual assessment of the CT imaging


Secondary Outcome Measures :
  1. Patient satisfaction score [ Time Frame: 6 months ]
    Patients' perspective of the degree of healing and rehabilitation following high tibial osteotomy

  2. Change in KOOS score [ Time Frame: 6 months ]
    difference in KOOS score , comparing per-operative vs 6 months post-operative.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717845


Contacts
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Contact: Leon Jonker, PhD 01228523444 leon.jonker@ncuh.nhs.uk

Locations
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United Kingdom
Cumberland Infirmary Recruiting
Carlisle, Cumbria, United Kingdom, CA2 7HY
Contact: Hannah Crowther, BSc       hannah.crowther@ncuh.nhs.uk   
Sponsors and Collaborators
North Cumbria University Hospitals NHS Trust
NuVasive
Investigators
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Study Director: Chris Hafner, PhD NuVasive
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Responsible Party: North Cumbria University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02717845    
Other Study ID Numbers: PR0251
16/NW/0038 ( Other Identifier: UK National Research Ethics Service )
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results to be published in peer-reviewed scientific journal
Keywords provided by North Cumbria University Hospitals NHS Trust:
varus malignment
osteoarthritis
knee
Additional relevant MeSH terms:
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Bone Malalignment
Bone Diseases
Musculoskeletal Diseases