To gain clinical experience for the Ellipse IM HTO Nail System in subjects with osteoarthritis and varus malalignment of the knee:1. To further evaluate the safety profile of the Ellipse IM HTO Nail System2. To further evaluate the efficacy of the…
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Efficacy Endpoint:
* Weight-Bearing Line at Final Correction within ±5, 10 and 15% of baseline
target
Secondary outcome
Secondary Efficacy Endpoints:
* Absolute Difference in Weight-Bearing Line
o Final Target versus actual at Final Consolidation
o Baseline Target versus Final Target
Change in Hip-Knee-Ankle Angle
o Baseline versus Final Correction
o Baseline versus Final Consolidation
Change in Tibial Slope
o Baseline versus Final Correction
o Baseline versus Final Consolidation
Time to full weight-bearing
Background summary
Peer-reviewed literature has established that the best results of HTO are
related to achieving the desired alignment with precision and without causing
secondary malalignment in other planes. Correction of alignment promotes
symptom relief and potential healing of damaged cartilage. Although each
patient presents a unique case requiring customized treatment, optimal
correction is generally defined when the weight-bearing line passed through a
point 62.5% of the tibial plateau width (also referred to as the *Fujisawa
Line*).
Angular alignment is the subject of more debate, with Insall et al.
recommending amechanical hip-knee-ankle angle of 170 degrees (± 5 degrees,
measured laterally) whereas Coventry et al. recommended a correction range of
170 degrees to 167 degrees.
An established relationship has been observed between over- and undercorrection
and poor clinical outcome. Undercorrection leads to a recurrence of varus
malalignment and is associated with persistenceor a recurrence of symptoms.
Overcorrection may result in unsatisfactory cosmetic result, persistent pain,
tilting of the joint line, and considerable boss loss if a closed wedge
technique is used.38,39 Inadequatepreoperative planning is a primary cause of
failure after high tibial valgus osteotomy.
Fixation and instability are the primary causes of loss of correction intra- or
post-operatively.
Several different navigation techniques are used to obtain optimal alignment,
and the accuracy of obtaining precise alignment varies. Marti et al. reported
that 16 of 32 (50%) knees showed the desired position of the mechanical axis
(within ± 5% of target) treated with medial open-wedge high tibial osteomy.43
El-Azab et al. showed that 29 of 50 patients (58%) achieved *best correction,*
defined as within ± 5% of target or 57-
67%. Difficulties obtaining precise alignment also exist with reference to HKA
angle. Brosset et al. reported a low success of achievement, observing that 5
of 51 knees reached the target HKA angle of 183 degrees, measured medially.
The Ellipse IM HTO Nail System offers the accuracy and post-operative
adjustability of external fixation
systems while also maintaining a lesser profile than a plate.
Study objective
To gain clinical experience for the Ellipse IM HTO Nail System in subjects with
osteoarthritis and varus malalignment of the knee:
1. To further evaluate the safety profile of the Ellipse IM HTO Nail System
2. To further evaluate the efficacy of the Ellipse IM HTO Nail System.
Study design
This is a postmarket prospective, open label, multi-center, single arm study
for osteoarthritis patients meeting the protocol eligibility criteria for a
high tibial osteotomy procedure using the Ellipse IM HTO Nail System.
Intervention
The intervention of this research involves the use of a CE marked medical
device, as this is not routinely used in the standard of care.
Study burden and risks
The potential risks associated with the Ellipse IM HTO Nail System include:
* Adverse reaction to device materials
* Infection
* Pain and loss of function
o Soft tissue tension
o Muscle tightness
o Joint stiffness
o Temporary loss of motion
o Contracture
o Loss of alignment
o Loss of range of motion
* Revision
* Implant Failure
* Distraction Failure
o Premature bone consolidation during distraction osteogensis
o Lack of osteogenic distraction
o Poor bone quality regenerate
o Failure to achieve desired angular correction
o Fracture of regenerate bone
o Delayed or non union at the osteotomy site
* Fracture of or damage to the the tibial plateau
* Fracture of or damage to the lateral tibial cortex.
* Surgical Complications
o Nerve or vessel damage resulting in insertion in the intramedullary canal
o Edema or swelling, possible compartment syndrome, wound or bone infection
o Pulmonary embolism
o Fat Embolism
o Thrombophlebitis
o Wound hematoma
o Avascular necrosis
o Tissue damage
o Death
boulevard Pereire 95 bis
PARIS 75017
NL
boulevard Pereire 95 bis
PARIS 75017
NL
Listed location countries
Age
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 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL53331.099.15 |