The primary objective of the study is to demonstrate non-inferiority of the KineSpring System, when compared to standard HTO surgery in improving pain and function outcomes at 24 months in patients with primarily unicompartmental medial knee…
ID
Source
Brief title
Protocol No: KINE-1101
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A patient will be declared a clinical efficacy success if all of the following
conditions are met at the 24-month follow-up:
1. Clinically significant improvement of at least 20% from baseline for the
WOMAC pain severity subscale with an absolute change of >=10 points.
2. Clinically significant improvement of at least 20% from baseline for the
WOMAC function subscale with an absolute change of >=10 points.
3. Maintenance of normal range of motion, defined as: a) knee flexion >=90 -
<=150 degrees, and b) knee extension within 10 degrees of the *neutral* or zero
degree position
4. No subsequent surgical intervention of the medial compartment of the treated
knee (including device failures requiring removal or revision); and no serious
device-related adverse events or device failures.
5. Maintenance of device integrity as evaluated by radiographic assessment.
Secondary outcome
Secondary Effectiveness Endpoint:
Clinical outcomes will be determined using the following outcome measurement
tools:
• To evaluate symptom severity changes from baseline measurement for each of
the following outcome measures at each follow-up visit:
o Knee Injury Outcomes Scores (KOOS) including WOMAC Pain, Stiffness and
Function Scores
o Knee Society Knee and Function Scores
o Knee range of motion as measured by degrees of flexion and extension
o Pain severity using the knee specific pain severity score (VAS)
o Patient assessment of global status
o High Arthroplasty Activity Score (HAAS)
o Generic health status using the EQ-5D
Radiographic outcomes will be evaluated using the following measurements:
• Kellgren-Lawrence OA classification
• OARSI Radiographic Altlas OA Score
• Device evaluation
Safety Endpoints:
Safety outcomes will be determined by evaluating by the type, frequency,
severity, and relatedness of adverse events through the 24-month timepoint for
all subjects.
Endpoints will be evaluated at 3, 4, and 5 years for the KineSpring arm in
addition to the timeframes specified above.
Background summary
Osteoarthritis affects an estimated 15% of the world*s population2. Knee OA is
the most predominant form, and approximately 90% of symptomatic patients
present primarily with medial compartment knee OA2-5. The prevalence of OA will
continue to rise with the increasing age and increasing lifespan of the
population. This condition decreases functional independence and in some
instances may impair the afflicted individual*s ability to complete normal
activities of daily living or participate in age-appropriate recreational
activities. Patients face progressive pain and disability for the remainder of
their lives. In spite of the prevalence and the extensive study of the disease,
no cure for OA has yet been identified.
The evidence implicating joint loading, and more specifically joint
overloading, in the OA process is well documented in the literature. Joint
overloading correlates to incidence, symptom severity, radiographic,
morphologic and biological processes. Load modifying treatments including
weight loss, valgus braces, HTO, external distraction devices clearly
demonstrate symptom relief*pain reduction and improved function. Despite these
positive results both physicians and patients are frustrated with the
inconsistent outcomes from these treatment options.
Given the increasing prevalence of OA in younger patients and the evident
potential of load management to positively impact these patients, the pursuit
of novel and innovative load modifying therapies that overcome the limitations
of the current treatment options is both warranted and necessary.
The KineSpring System is expected to provide a clinically beneficial reduction
of load on the diseased surface within the knee, by acting as an
extra-articular supplemental load path to the affected joint. Additionally, the
KineSpring System has no known detrimental effect on natural knee kinematics
since it is implanted via relatively small incisions without disrupting bone,
cartilage, or ligaments. Important advantages of the KineSpring System,
especially for patients who want to remain active and healthy, include the
potential for quick postoperative recovery and joint mobility, and the ability
to preserve natural joint anatomy so that future surgical options remain open
for the patient
Study objective
The primary objective of the study is to demonstrate non-inferiority of the
KineSpring System, when compared to standard HTO surgery in improving pain and
function outcomes at 24 months in patients with primarily unicompartmental
medial knee osteoarthritis.
Study design
This study is designed as a multi-center prospective, non-randomized,
non-inferiority, two-arm, active concurrent, controlled trial. Up to 30 sites
will enroll a minimum of 225 subjects and maximum of 450 subjects in a 2:1
ratio (KineSpring to HTO). Patients (subjects) who have been diagnosed with
symptomatic osteoarthritis primarily in the medial compartment of the knee will
be enrolled concurrently into either the KineSpring arm or HTO surgical arm.
The test arm will consist of a minimum of 150 subjects and a maximum of 300
subjects who are implanted with the KineSpring device. The control group will
consist of a minimum of 75 subjects and a maximum of 150 subjects who will
undergo HTO surgery for the treatment of symptoms associated with medial knee
OA. There will be no adjustment to the sample size due to loss of follow-up.
The adaptive sample size is based upon the number of patients required to
provide assurance of safety and effectiveness using the concurrent control and
allowing for 15 percent loss to follow up.
Follow-up visits and examination will occur for all patients at 6 weeks, and 3,
6, 12 and 24 months post-enrollment to collect data for the primary evaluation
of safety and effectiveness with annual follow up thereafter for the KineSpring
patients only.
At each follow-up visit, subjects will be interviewed to determine if adverse
events (AEs) were experienced since the previous follow-up visit. A complete
orthopaedic knee assessment will be performed at baseline for all subjects and
again during each follow-up. All subjects will be required to complete WOMAC,
KOOS, knee pain severity score and global assessment, HAAS, and EQ-5D to
evaluate, disability, function, pain, and quality of life at each follow-up
visit.
Radiographic evaluations will be performed at baseline, discharge, and 3, 12,
and 24 months for all patients and at 5 years post-operatively for KineSpring
patients.
Intervention
The KineSpring System (Moximed, Hayward, CA, USA) is a CE Marked
extra-capsular knee implant that consists of titanium alloy femoral and tibial
bases, and a cobalt/cobalt chrome alloy absorber that reduces the load
transferred to the diseased medial compartment of the knee joint. The
KineSpring System is implanted through two medial incisions, one on the distal
femur and one on the proximal tibia. The femoral and tibial bases are secured
to the femur and tibia, respectively, using bone screws. The absorber consists
of central spring elements that provide compressive load absorption and an
articulating ball and socket joint at each end that allow the device to
accommodate the natural motions of the knee. The absorber is connected to the
femoral and tibial bases and implanted in the subcutaneous tissue of the medial
extra-capsular space. The KineSpring System remains extra-articular.
Study burden and risks
The potential risks for subjects implanted with the KineSpring System enrolled
in the trial include 1) those related to any invasive surgery 2) risks
associated with orthopedic knee implants, 3) risks associated with radiography.
In addition, there is always a chance that unforeseen risks may also occur.
Risks associated with general surgery include:
• adverse reactions to anesthesia (neurological, cardiac and respiratory
deficit)
• blood loss, blood vessel damage, phlebitis or hematoma
• blood transfusion which may cause circulatory collapse, blood
incompatibility, kidney damage, hepatitis, infection with HIV
• myocardial infarction
• deep vein thrombosis, pulmonary embolism or thrombus formation in other
vessels
• stroke
• fever
• pneumonia
• respiratory distress
• injury to muscle, soft tissues or nerves
• wound swelling, draining or delayed healing
• pain and rehabilitation associated with recovery from surgery
• inability to perform certain tasks, such as lifting, exercising etc.
• death
Risks associated with orthopedic knee implants:
• Implant malposition resulting in mechanical failure, device loosening, or
lack of efficacy
• Mechanical failure of the device or components
• Implant may fail mechanically (loosen, deform, disassemble, disarticulate,
break, fatigue or migrate) which may necessitate
another surgery
• Wear debris that may cause irritation or tissue reaction
• Allergies to implant materials or foreign body reaction
• Failure of implant to improve symptoms and/or function
• Infection may necessitate another surgery to treat the infection
• Irritation or inflammation to the surrounding tissues that may result in
discomfort, synovitis or bursitis
• Damage to or compromise of adjacent neurovascular structures, lymphatic
structure, or ligaments
• Insufficient or limited range of motion of the knee
• Potential for bone loss or fracture
• Overloading of the lateral compartment
• Pain, stiffness or swelling of the knee
• Stitch abscess
• Allergic reaction to suture/dressing
• Cellulitis
• Keloid like scar formation
• Hematoma
• Knee scarring, arthrofibrosis, or periprosthetic local adhesions
• Audible clicking, squeaking, or other noise may be associated with the
KineSpring device
Some of the complications may lead to subsequent surgical intervention for
revision, removal, reoperation or other surgical intervention. This list of
risks is not an exhaustive list and it is understood that any or all risks are
possible.
Risks Associated with Radiographs:
The series of radiographs required for this study are similar to routine knee
surgery radiographs and will expose the subject to small doses of radiation.
The maximum estimated x-ray exposure over the course of the study is about
0.135 mSv or 13.5 mrem. This is approximately equivalent to a uniform whole
body exposure of 16.4 days (0.045 years) of exposure to natural background
radiation. The risk of any side effects from this level of exposure is minimal.
26460 Corporate Avenue /
Hayward CA 94545
US
26460 Corporate Avenue /
Hayward CA 94545
US
Listed location countries
Age
Inclusion criteria
1. Male or female subjects 25 to 80 years of age
2. Documented diagnosis of knee OA (osteoarthritis or post-traumatic osteoarthritis), which includes clinical symptoms of medial compartment osteoarthritis (pain primarily localized to the medial aspect of the knee and generally exacerbated by weight bearing)
3. Radiographic confirmation of mild to moderate medial compartment knee OA as demonstrated by a Kellgren-Lawrence grade of 1, 2 or 3 (scale 0-4) as assessed by the Investigator
4. Has failed at least six months of conservative treatment prior to surgery with continued OA pain. Prior conservative therapy is defined as treatment including at least one of the following:
a. Lifestyle modification
b. Weight loss, if BMI >25
c. Pain relievers
d. IA corticosteroid injections
5. Knee flexion range >=90 - <=150 degrees
6. WOMAC pain score of at least 40 (scale 0-100) at the baseline visit
7. BMI < 35 or weight < 300 lbs
8. Candidate for a high tibial osteotomy procedure
9. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
10. Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.
Exclusion criteria
1. Symptomatic OA in lateral or patellofemoral compartment of affected knee, i.e. clinical symptoms or radiographic evidence of advanced OA in lateral or patellofemoral compartment of the affected knee
2. Symptomatic OA with Kellgren Lawrence Grade 4 in the contralateral knee likely to necessitate surgical intervention within 12 months of enrollment, i.e. contralateral knee has radiographic evidence of severe OA (Kellgren Lawrence Grade 4), clinical findings of severe OA (severe joint pain or limitation of movement) or symptoms that interfere with activities of daily living, stair climbing, stair descending or requires the use of an assist device
3. Tibial-femoral varus or valgus alignment >10 degrees (assessed by the investigator)
4. Flexion deformity > 10 degrees
5. Hyperextension >5 degrees
6. Severe deformities leading to impaired fixation or improper positioning of the implant
7. Pathologic ligamentous instability (>1 MCL injury or Lachman >1) as assessed by the Investigator on physical examination
8. Neuropathic pain or fibromyalgia, or any knee or other pain requiring chronic pain management.
9. Active infection, sepsis or osteomyelitis, history of infection in the target knee or distant foci of infections which may spread to the implant site
10. Previous joint modifying surgery in the target knee are excluded within 12 months prior to planned study surgery date, such as ligament reconstruction or meniscus repair, cartilage transplantation, and microfracture. Arthroscopic surgeries for joint lavage, menisectomy, chondral debridement, and loose body removal are excluded within 3 months prior to planned study surgery date.
11. Previous osteotomy or failed knee joint replacement in the target knee
12. Known sensitivity to metal implants
13. Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder
14. Paget*s disease or metabolic disorders which may impair bone formation
15. Moderate to severe osteoporosis or pathologic fractures as evidenced by radiolucency of the femoral or tibial cortex on x-ray
16. Charcot*s joint disease or other severe neurosensory deficits
17. Immunologically suppressed or immunocompromised
18. History of systemic steroid treatment, medication use that affects bone metabolism (such as chemotherapy) within the previous 6 months, or radiotherapy within the previous 6 months
19. Any significant medical condition (e.g., diabetes mellitus requiring daily insulin therapy, advanced liver disease, advanced kidney disease, congestive cardiac failure, uncontrolled transient ischemic attack, cancer, radicular symptoms associated with lumbar spine pathology); significant psychiatric disorders (such as major depression, anxiety disorders, bipolar disorders and schizophrenia), history of or active alcohol/drug abuse (meeting standard diagnostic criteria described in the Diagnostic and Statistical manual for Mental Disorders DSM-IV); or other factors (e.g. planned relocation, uncooperative patient)
20. Under litigation or workers compensation for musculoskeletal injuries or disorders
21. Is either pregnant or interested in becoming pregnant during the duration of the study
22. Subjects who are currently involved in any investigational drug or device trial or have been enrolled in such trials within the last 3 months.
23. Prisoners or wards of the state.
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 |
|---|---|
| ClinicalTrials.gov | NCT01610505 |
| CCMO | NL38105.094.13 |