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

NCT03431662 | Completed

• 1 other identifier: PR0251
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis; Varus Malalignment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual Analog Pain Scale

  6-month postoperative

• Osteotomy patient satisfaction questionnaire

  6-month postoperative

• SF-12 Quality of Life Questionnaire

  6-month postoperative

• KOOS Knee Health Questionnaire

  6-month postoperative

Study Arms (2)

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.

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.

Procedure: TomoFix

Interventions

Ellipse IM HTO Nail PROCEDURE

A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.

Also known as: Computerized Tomography (CT) Scan

Ellipse IM HTO Nail

TomoFix PROCEDURE

A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.

Also known as: Computerized Tomography (CT) Scan

TomoFix

Eligibility Criteria

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

You may qualify if:

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

Sponsors & Collaborators

• Ellipse Technologies, Inc.: lead

Study Sites (1)

North Cumbria University Hospitals NHS Trust

Carlisle, CA2 7HY, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

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

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: February 13, 2018
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)