Clinical trial NCT02412163: Ellipse Intramedullary Nail High Tibial Osteotomy Study
Official title: A Multicenter Study of Patients Treated With the Ellipse Technologies Intramedullary High Tibial Osteotomy (IM HTO) Nail System for Osteoarthritis and Varus Malalignment of the Knee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Varus Malalignment
Lead sponsor: Ellipse Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-09
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who meet the protocol eligibility criteria including standing varus malalignment in the limb presenting with osteoarthritis of the knee.

Brief summary: This study further evaluates the safety profile and efficacy of the Ellipse IM HTO Nail system in subjects with osteoarthritis and varus malalignment of the knee. All subjects will receive treatment with the Ellipse IM HTO Nail System and followed for six months.

Detailed description: The Ellipse IM HTO Nail is intended for open wedge proximal tibial osteotomies. The Ellipse IM HTO Nail is an intramedullary nail that operates on the principles of distraction osteogenesis.

The Ellipse IM HTO Nail is used in valgizing HTO procedures to correct varus malalignment. The Ellipse IM HTO Nail is surgically placed in the intramedullary canal of the tibia. It is lengthened telescopically using the non-invasive external remote control.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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 patellofemoral 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

Primary outcomes:
measure: Weight-Bearing Line at Final Correction within ±5, 10, and 15% of Baseline Target
timeFrame: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
Secondary outcomes:
measure: Absolute Difference in Weight-Bearing Line Final Target versus Actual at Final Consolidation
timeFrame: Week 6 (Considered the Final Correction Visit unless additional visits are required), Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
measure: Absolute Difference in Weight-Bearing Line Baseline Target versus Final Target
timeFrame: Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
measure: Change in Hip-Knee-Ankle Angle Baseline versus Final Correction
timeFrame: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
measure: Change in Hip-Knee-Ankle Angle Baseline versus Final Consolidation
timeFrame: Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
measure: Change in Tibial Slope Angle Baseline versus Final Correction
timeFrame: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
measure: Change in Tibial Slope Angle Baseline versus Final Consolidation
timeFrame: Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required)
measure: Time to Full Weight-Bearing
timeFrame: Week 2, Week 4, Week 6, Month 3, Month 6
Other outcomes:
measure: Serious Adverse Events
timeFrame: Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6
measure: Unanticipated Adverse Device Effects
timeFrame: Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6
measure: Non-Serious Adverse Events
timeFrame: Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6
measure: Secondary Surgical Procedures
timeFrame: Pre-Op, Operative, Week 2, Week 4, Week 6, Month 3, Month 6
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Bialystok
country: Poland
facility: Centrum Ortopedii I Traumatologii
city: Lublin
country: Poland
facility: Zagiel Hospital
city: Warsaw
country: Poland
facility: Lekmed Hospital
city: Wolomin
country: Poland
facility: District Hospital of Wolomin
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Carlisle
country: United Kingdom
facility: North Cumbria University Hospital
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton
Study officials:
affiliation: University of Minnesota
name: Mark T Dahl, MD
role: PRINCIPAL_INVESTIGATOR
References: