OsteoarthritisCISKONCT03431662
Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy
A study testing Ellipse IM HTO Nail and TomoFix in people with Osteoarthritis and Varus Malalignment, run by Ellipse Technologies, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Osteoarthritis, Varus Malalignment
- What is being tested?
- Ellipse IM HTO Nail and TomoFix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indicated treatment with medial open wedge proximal tibial osteotomy, either with Tomofix device or Ellipse device
- Provision of written informed consent
- Males
- Mental capacity
Who cannot join
- Under age (< 18 years)
- Patients lacking mental capacity.
- Females
- Current use of nicotine products.
- Patients who cannot understand English and therefore cannot be consented.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North Cumbria University Hospitals NHS Trust
Carlisle, CA2 7HY
About this study
Official title: Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge
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.
Read the 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.
- Conditions
- Osteoarthritis, Varus Malalignment
- Being tested
- Ellipse IM HTO Nail, TomoFix
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ellipse IM HTO NailProcedure or surgery
Also called Computerized Tomography (CT) Scan
A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
TomoFixProcedure or surgery
Also called Computerized Tomography (CT) Scan
A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Ellipse IM HTO Nail | Experimental | 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. Receives: Procedure: Ellipse IM HTO Nail |
| TomoFix | Active comparator | 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. Receives: Procedure: TomoFix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-month postoperative
Secondary outcomes (4)
Visual Analog Pain Scale
A patient reported outcome of their perception of pain
Measured: 6-month postoperative
Osteotomy patient satisfaction questionnaire
A patient reported outcome of the patient's perception of satisfaction with treatment
Measured: 6-month postoperative
SF-12 Quality of Life Questionnaire
A validated patient reported outcome.
Measured: 6-month postoperative
KOOS Knee Health Questionnaire
A validated patient reported outcome.
Measured: 6-month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study startMar 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellipse Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431662
- Sponsor's protocol ID
- PR0251
- Acronym
- CISKO
- Status last verified
- Feb 2018
- First submitted
- 20 Jul 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge
- ClinicalTrials.gov ID
- NCT03431662
- Acronym / sponsor ID
- CISKO / PR0251
- Conditions
- Osteoarthritis, Varus Malalignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ellipse Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ellipse IM HTO Nail | Experimental | Procedure: Ellipse IM HTO NailIn 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. |
| TomoFix | Active comparator | Procedure: TomoFixIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indicated treatment with medial open wedge proximal tibial osteotomy, either with Tomofix device or Ellipse device
- Provision of written informed consent
- Males
- Mental capacity
Key exclusion criteria (5 listed)
- Under age (< 18 years)
- Patients lacking mental capacity.
- Females
- Current use of nicotine products.
- Patients who cannot understand English and therefore cannot be consented.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ellipse IM HTO NailAlso: Computerized Tomography (CT) ScanA CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months. | Procedure or surgery | Ellipse IM HTO Nail |
| TomoFixAlso: Computerized Tomography (CT) ScanA CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months. | Procedure or surgery | TomoFix |
Primary outcome
Healing of the osteotomy site
Time frame: 6-month postoperative
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
4 secondary outcomes
Visual Analog Pain Scale
Time frame: 6-month postoperative
Osteotomy patient satisfaction questionnaire
Time frame: 6-month postoperative
SF-12 Quality of Life Questionnaire
Time frame: 6-month postoperative
KOOS Knee Health Questionnaire
Time frame: 6-month postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ellipse IM HTO Nail and TomoFix in people with Osteoarthritis and Varus Malalignment, run by Ellipse Technologies, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of the osteotomy site (time frame: 6-month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.