CT Imaging Study for Knee Osteotomy (CISKO)

NCT02717845 | Unknown

• 2 other identifiers: PR025116/NW/0038
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Malalignment

Keywords

varus malignment; osteoarthritis; knee

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Patient satisfaction score

  6 months

• Change in KOOS score

  6 months

Study Arms (2)

CT scan Ellipse

EXPERIMENTAL

New medical device for high tibial osteotomy

Device: Ellipse

CT scan Tomofix

ACTIVE COMPARATOR

Established medical device for high tibial osteotomy

Device: Tomofix

Interventions

Ellipse DEVICE

diagnostic CT scan imaging

CT scan Ellipse

Tomofix DEVICE

diagnostic CT scan imaging

CT scan Tomofix

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• Males
• Mental capacity

You may not qualify if:

• Under age (\< 18 years)
• Patients lacking mental capacity.
• Females
• Current use of nicotine products.
• Patients who cannot understand English and therefore cannot be consented.
• Varus deformity greater than 10°
• Flexion contracture greater than 15°
• Knee flexion under 90°
• Medial/lateral tibial subluxation over 1 cm
• Medial bone loss of over 3 mm
• Inflammatory arthritis (including use of methotrexate)
• Arthritis in the lateral compartment
• Patella baja
• Weight over 114 kg
• Severe patella femoral symptoms

Sponsors & Collaborators

• North Cumbria University Hospitals NHS Trust: lead
• NuVasive: collaborator

Study Sites (1)

Cumberland Infirmary

Carlisle, Cumbria, CA2 7HY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Bone Malalignment; Osteoarthritis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• Chris Hafner, PhD

  NuVasive

  STUDY DIRECTOR

Central Study Contacts

Leon Jonker, PhD

CONTACT

01228523444; leon.jonker@ncuh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 24, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 8, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)