A Multicenter Study of Patients treated with the EllipseTechnologies Intramedullary High Tibial Osteotomy (IM HTO) Nail System for Osteoarthritis and Varus Malalignment of the Knee
- Conditions
- arthritis1002321310005944
- Registration Number
- NL-OMON42426
- Lead Sponsor
- MEDPASS INTERNATIONA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1. Patient has standing varus malalignment benefitting from high tibial
osteotomy correction
2. Patient is diagnosed with current osteoarthritis of the knee
3. Patient is eighteen years of age or greater
4. Patient is a candidate to be implanted with an Ellipse IM HTO System
5. If female of childbearing potential, patient presents with a negative
pregnancy test and agrees to employ adequate birth control measures for
the duration of the study
6. Patient understands and accepts the obligation to comply with the
required follow-up visits and is logistically able to meet all study
requirements
7. Patient signs informed consent for the use of their personal private data
1. Patient declines to sign informed consent for the use of their personal
private data
2. Varus deformity greater than 10°
3. Flexion contracture greater than 15°
4. Knee flexion under 90°
5. Medial/lateral tibial subluxation over 1 cm
6. Medial bone loss of over 3 mm
7. Inflammatory arthritis
8. Arthritis in the lateral compartment
9. Patella baja
10. Weight over 114 kg
11. Severe patellafemoral symptoms
12. Unaddressed ligamentous instability
13. Fixed flexion contracture
14. Known or suspected osteoporosis or osteopenia based on medical
history and radiographic images
15. Current use of nicotine products.
16. Requires other surgical procedures at the time of the HTO surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Endpoint:<br /><br>* Weight-Bearing Line at Final Correction within ±5, 10 and 15% of baseline<br /><br>target</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Efficacy Endpoints:<br /><br>* Absolute Difference in Weight-Bearing Line<br /><br>o Final Target versus actual at Final Consolidation<br /><br>o Baseline Target versus Final Target<br /><br>Change in Hip-Knee-Ankle Angle<br /><br>o Baseline versus Final Correction<br /><br>o Baseline versus Final Consolidation<br /><br>Change in Tibial Slope<br /><br>o Baseline versus Final Correction<br /><br>o Baseline versus Final Consolidation<br /><br>Time to full weight-bearing</p><br>