Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge Proximal Tibial Osteotomy

Osteoarthritis Clinical Trial

— CISKO  

Official title:

Computerized Tomography (CT) Scan Study of Bone Healing Following Open Wedge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431662
• Other study ID #: PR0251
• Status: Completed
• Phase: N/A
• First received: July 20, 2017
• Last updated: February 12, 2018
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2018
• Source: Ellipse Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Indicated treatment with medial open wedge proximal tibial osteotomy, either with Tomofix device or Ellipse device

2. Provision of written informed consent

3. Males

4. 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Varus Malalignment

Intervention

Procedure:
• Ellipse IM HTO Nail
A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
• TomoFix
A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.

Locations

Country	Name	City	State
United Kingdom	North Cumbria University Hospitals NHS Trust	Carlisle

Sponsors (1)

Lead Sponsor	Collaborator
Ellipse Technologies, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6-month postoperative
Secondary	Visual Analog Pain Scale	A patient reported outcome of their perception of pain	6-month postoperative
Secondary	Osteotomy patient satisfaction questionnaire	A patient reported outcome of the patient's perception of satisfaction with treatment	6-month postoperative
Secondary	SF-12 Quality of Life Questionnaire	A validated patient reported outcome.	6-month postoperative
Secondary	KOOS Knee Health Questionnaire	A validated patient reported outcome.	6-month postoperative