The objective of this study is to evaluate the safety and technical feasibility of the Latella Implant in the treatment of patients with medial osteoarthritis of the knee.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety is the primary endpoint of this clinical investigation and will be
evaluated by:
* Freedom from unanticipated serious device related adverse events up to 12
months after implantation surgery
* Freedom from radiographic evidence of screw loosening up to 12 months after
implantation surgery.
NOTE: This does not include natural disease progression.
Secondary outcome
Performance (technical feasibility) is the secondary endpoint of this clinical
investigation and will be evaluated as the ability of the Latella Implant to be
placed under the iliotibial band and fixed to the distal, lateral aspect of the
femur.
Additional exploratory outcome measures are:
1. Patient Reported Outcome scoring of joint specific, disease specific and
general Quality of Life measures using:
* Knee injury and Osteoarthritis Outcome Score (KOOS)
* International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Form
* 36-Item Short Form Health Survey (SF-36) administered by either the RAND 36
Item Short Form Health Survey (SF-36 specific form) or by the IKDC Current
Health Assessment Form, which includes the SF-36 questions
* Patient Global Assessment (PGA)
* Anterior Knee Pain Scale (Kujala)
2. Radiographic analysis to evaluate :
* Joint space width (comparison between baseline and 3, 6, 12 and 24 months
post implantation)
* Development of ectopic calcification post implantation
* Patellar tracking via skyline view. Intra-operative images only, follow-up
imaging will be performed by MRI
* Standing axis view of leg to determine varus angle and to see if alignment
shifts from pre-operative to 3 months post implantation
3. MRI analysis to evaluate:
* Meniscal extrusion
* Articular cartilage morphology
* Subarticular marrow edema
* Subarticular bone attrition
4. Three-Dimensional Gait Analysis to evaluate:
* Adduction moment
* Toe-out angle
Background summary
Knee Osteoarthritis (OA) afflicts over 15M individuals in the US. OA is
sometimes referred to as degenerative, or wear and tear, arthritis. It is a
progressive degenerative disease characterized by the breakdown of articular
cartilage. Over time, the cartilage may wear away entirely, resulting in
bone-on-bone contact, resulting in joint pain and stiffness. Since bones,
unlike cartilage, have many nerve cells, direct bone contact can be very
painful to the OA sufferer. In addition to the pain and swelling, the OA
sufferer can experience a progressive loss of mobility at the knee joint. This
is due to loss of the joint space, where the articular cartilage has completely
worn away.
OA usually affects the side of the knee closest to the other knee (called the
medial compartment) more often than the outside part (the lateral compartment).
OA in the medial compartment can lead to bowing of the knee. A bowlegged
posture places more pressure than normal on the medial compartment. The added
pressure leads to more pain and faster degeneration where the cartilage is
being squeezed together. Knee OA is typically caused by excessive mechanical
load on the medial condyle.
Treatment for medial knee OA relies on unloading the medial condyle by shifting
the load back towards the midline of the knee. Current therapy includes
exercise, weight loss, external bracing, internal and external surgical
mechanical distraction and tibial osteotomy. Current surgical treatment are
either limited in their efficacy or are very invasive. Hence, there is room for
improvement in the treatment of patients with knee OA.
Cotera has developed a novel device, the Latella Implant, to provide patients
with a low invasive treatment alternative for early to mid-stage OA. The
Latella Implant has the potential to not only reduce joint pain but it may also
slow down the progression of OA. Furthermore, the ease of manufacturability of
the novel device and the minimal invasiveness of the surgical procedure would
make this treatment cost effective relative to the current surgical options.
Study objective
The objective of this study is to evaluate the safety and technical feasibility
of the Latella Implant in the treatment of patients with medial osteoarthritis
of the knee.
Study design
Prospective, non-randomized, single-arm, multi-centre study
Intervention
Medical device: Latella Implant
Surgery: Implantation of the Latella Implant during a surgery. Incision will be
about 5 cm.
Study burden and risks
After the implantation surgery, the patients will be asked to return for 9
post-operative hospital visits (at 2 weeks and 3, 6 ,12, 18, 24, 36, 48 and 60
months after surgery). According to the investigators of the Slotervaart
Hospital, the number of visits is comparable to similar type of treatments of
the knee. Therefore, the number of follow-up visits is thus not considered as
an extra burden for the patients. However, the patients are being asked to
complete 5 questionnaires (KOOS, IKDC,SF36, PGA and Kujala) at baseline, 3, 6,
12, 18, 24, 36, 48 and 60 months follow up visits. The investigators consider 6
X-rays as non-standard of care, being the radiograph at baseline and 24 months
to determine the minimal joint space width, the X-rays at 36, 48 and 60 months
to determine screw loosening and ectopic calcification and an X-ray of the
standing axis view at 3 months after surgery. In addition, all MRI assessments
(at baseline and 6, 12 and 24 months post-op) are considered as not standard of
care by the investigators. Also, the patient is asked agree to do gait analysis
at screening and 3 and 12 month visit. The gait analysis assessments are
optional. The burden of the hospital visits and the examinations during these
visits are considered similar to that of other orthopedic clinical trials, and
are necessary to evaluate the candidate technology and ensure subject health
and safety.
Literature shows that there are no less-invasive surgical options available for
patients with significant knee pain. After conservative care has failed, the
only option prior to knee replacement for patients today is high tibial
osteotomy (HTO). The anticipated clinical benefit of the use of the Latella
Implant is to relieve knee pain and to improve knee function of patients
suffering from medial osteoarthritis in the knee, thereby improving the
subject*s quality of life. It may also reduce the rate of disease progression.
The Latella Implant is not expected to halt or reverse disease progression.
Eventual removal of the device and future treatment with more invasive surgical
intervention is expected. While the durability of the effect is yet unknown, it
may be expected to approach that of tibial osteotomy, which can exceed five
years.
The Latella-specific risks are described in section E9/E9a. These risks are
considered to be comparable to the risks related to HTO.
Jefferson Dr 199
Menlo Park CA 94025
US
Jefferson Dr 199
Menlo Park CA 94025
US
Listed location countries
Age
Inclusion criteria
1. History of pain diagnosed as due to medial osteoarthritis with failure of pain relief from non-operative therapy
OR failure of pain relief 6 months post arthroscopic treatment for medial osteoarthritis (see exclusion criteria for excluded procedures)
2. Age: 30 * 65 years
3. Weight: Less than 110 kg
4. Kellgren-Lawrence scores: Grades 2-3
5. Willing and able to understand and sign the informed consent
Exclusion criteria
* Varus angle > 10 degrees
* Osteoporosis
* Rheumatoid arthritis
* Immunosupressive disorders, for example, diabetes
* Chronic steroid use
* History of heterotopic ossification
* Ligament instability
* Joint instability
* Capsule contracture
* Ligament contracture
* Radiologic evidence of patellar osteoarthritis which in the opinion of the treating physician would preclude enrollment
* History of patellar instability including: Subluxation, Dislocation, Maltracking, Excessive anterior knee pain
* Radiologic evidence of lateral osteoarthritis
* Post-traumatic osteoarthritis
* Lateral osteophytes that would underlie implant region (diagnosed via x-ray)
* Free floating bodies
* Prior surgery or trauma in or near the intended implant site which would create scar tissue and interfere with the implant surgery.
o NOTE: Partial medial meniscectomy will be allowed
* Prior anterior cruciate ligament reconstruction
* Tight Illiotibial Band or Illiotibial Band Syndrome
* Femoral or tibial bone deformity
* Bone metabolic disease not associated with osteoarthritis
* Disease affecting the connective tissue or muscle
* Continued participation in contact sports
* Less than 5 year history free of lung, colorectal, breast, thyroid, prostate, or kidney cancer
* Less than 5 year history free of primary bone tumors
* History of stroke, upper limb or lower limb motor disorders
* Bleeding diathesis
* Chronic use of anticoagulants
* Metal ion allergy
* Absolute or relative contraindication for MRI
* No fixed abode
* Substance abuse (drug or alcohol)
* For women of childbearing potential: pregnant, or willing to become pregnant during the course of the clinical investigation
* Have been exited from in another clinical study less than 30 days prior to enrollment in this clinical study, currently participating in another clinical study or plan to be enrolled in another clinical study during the course of this study.
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 | NL44476.048.13 |