The primary objective is to assess 2-year survivorship of Total Knee Arthroplasty (TKA) procedures performed using the Smith+Nephew (S+N) Porous Knee System. The secondary objective is to generate safety and performance evidence up to 5 years post-…
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Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for the study is implant survivorship 2 years
post-surgery. Implant survivorship is defined as the cumulative proportion of
knee-implanted components without a revision.
Secondary outcome
Survivorship of the implant will be assessed at 1-, 2- and 5-year timepoints.
Survivorship of the implant will be defined as the cumulative proportion of all
knee implant components without a revision.
The patient reported outcomes collected at pre-op, 6 weeks, 6 months, 2 years
and 5 years:
• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR).
• Oxford Knee Score (OKS).
• Forgotten Joint Score (FJS).
Additional secondary endpoints include:
• Radiographic findings (pre-op, 6 weeks, 6 months, 2 years and 5 years)
• Post-op device related re-interventions related to operative knee.
• Survival rate up to 5 years post-op.
2. Safety Endpoints
• All adverse events (AEs) and complications occurring from the time of surgery
until study
termination or study completion including intra-operative adverse events and
complications.
• Device related re-interventions
• Device Deficiencies
3. Other exploratory endpoint(s):
• Operating time from first incision to final skin closure (skin-to-skin time).
• Accuracy of device positioning (difference between planned vs. actual).
Background summary
Osteoarthritis, also known as degenerative joint disease, is the most common
type of arthritis occurring primarily in the weight-bearing joints of the
knees, hips, and spine as well as joints exposed to prior injury or repeated
stress. It is characterized by the breakdown of the protective cartilage that
cushions the ends of bones in joints with diagnosis based on clinical
assessment of signs and symptoms along with imaging methods. The symptoms of
osteoarthritis such as pain, inflammation, and limited function can be managed
and disease progression slowed; however, the damage to the joints cannot be
reversed. If left untreated, there is the potential over time for cartilage to
wear down completely leading to bone deterioration.
The incidence of joint disease continues to increase, with an estimated 9.3
million adults affected by knee osteoarthritis in the United States (US). The
recent upward trend appears to be directly related to the prevalence of certain
health factors that may significantly contribute to joint
degeneration, specifically, longer life spans, obesity rates, and physical
activity levels.
While treatment strategies such as weight reduction, lifestyle changes,
physical therapy, or medication may offer temporary relief from the symptoms of
knee degeneration, an ever-growing percentage of the affected population may
choose to have total knee arthroplasty (TKA). TKA remains the standard of care
for subjects experiencing significant losses in quality of life due to advanced
osteoarthritic disease.
The optimal mode of fixation in TKA with the majority of surgeons is cemented
fixation. Cemented prostheses are regarded as the gold standard for TKA,
supported by the long-term clinical success and survivorship analysis from
registry-based and clinical studies. Cementless fixation is, however, of
interest, as the potential benefits of cementless fixation include promotion of
bone growth and therewith fixation on longer term, and shorter operating room
time.
The purpose of this study is to evaluate the safety and performance of the
cementless Porous TKA System over 5 years in patients undergoing TKA for
post-traumatic arthritis, osteoarthritis, or degenerative arthritis. Data from
this study will be incorporated into the post-market surveillance
body of knowledge on the LEGION and JOURNEY II Porous Systems.
Study objective
The primary objective is to assess 2-year survivorship of Total Knee
Arthroplasty (TKA) procedures performed using the Smith+Nephew (S+N) Porous
Knee System. The secondary objective is to generate safety and performance
evidence up to 5 years post-surgery for S+N*s Porous Knee System via the
collection of functional outcomes, radiograph findings and safety data.
Study design
The POROUS.TKA.SYSTEM.2021.07 study is a premarket, multi-centre, prospective,
non-randomized, interventional study with an enrollment phase of approx. 38
months and up to 5 years follow up.
Intervention
The Porous TKA System will be used per the current IFU for device type, size,
preparation, and recommended implant procedure. Each subject will be implanted
with a Porous Tibia Base Plate, a LEGION CR femoral component along with an
insert and optional patella.
The implantation of a primary total knee arthroplasty is a surgical procedure
supported by a multidisciplinary team (MDT) of healthcare professionals.
Variations in practice rightly occur between surgeons, theatre teams, and
hospitals. However, the following provides a high-level descriptor of the major
steps relating to the patient journey both in the medical and surgical context.
The surgical procedure may be divided into the pre-operative, intra-operative
and post-operative periods.
1. A pre-operative orthopaedic assessment of the joint and its suitability for
an implant, and a pre-operative anaesthetic assessment will be performed.
Additional pre-operative surgical considerations include radiographic
templating.
2. Intra-operatively, the patient will be supine, and some form of a leg holder
can keep the knee at 90 degrees or more of flexion during certain parts of the
procedure. The surgeon will use the approach that fits the patient and implant
requirements, and one they are most comfortable with. The instrument sets to be
used are pre-market products, which will be provided as ancillary products.
Surgery consists of an arthrotomy and deep exposure, followed by bone cuts of
the femur and tibia. Thereafter, soft tissue balancing and confirmation of the
final implants through trials, and final implant placement is followed with
meticulous wound closure.
Perioperative or immediate post-operative inpatient management (monitoring of
early vital signs, analgesia, progressive physiotherapy, general
nursing) will be done.
3. Postoperative outpatient care is guided by the surgeon but most heavily
reliant on an MDT most prominent of which are physiotherapists.
Surgical follow-up to discharge varies according to each hospital and the
commissioning agreements that they have for care.
Study burden and risks
The risks related to the surgery are similar to standard of care total knee
replacements.
There are risks associated with Porous Total Knee System:
• Wear of polyethylene articulating surfaces if knee prostheses. High rates of
wear may shorten useful life of knee system and lead to early revision surgery
• Localised, asymptomatic bone resorption (osteolysis) around components due to
foreign body interaction and wear between components
• Loosening, bending, cracking or fracture of implant components as a result of
trauma, improper alignment, strenuous activity or long-term use
• Dislocation, subluxation, excessive rotation flexion contracture, decreased
range of motion, lengthening or shortening of the leg, looseness of components,
unusual stress concentrations and extraneous bone as a result of trauma,
improper implant selection or improper implant positioning/fixation
Since the Porous Total Knee System is an investigational device, it is possible
that new and so far, unknown risks/discomforts may occur.
Possible risks that may occur as a direct result of this study is related to
the additional X-Ray exposure.
The patient has been informed about all of these risks in the informed consent
form.
Brooks Road 1450
Memphis, Tennessee 38116
AF
Brooks Road 1450
Memphis, Tennessee 38116
AF
Listed location countries
Age
Inclusion criteria
1. Subject needing primary TKA due to degenerative joint disease (primary
diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory
arthritis.
2. Subject agrees to consent and to follow the prospective study visit schedule
(as defined in the study protocol and informed consent form) by signing the
Independent Review Board (IRB)/Independent Ethics Committee (IEC) approved
informed consent form.
3. Subject is willing to attend study follow-up visits for up to five (5) years
post-surgery.
4. Subject is able to read, understand, and communicate responses to Patient
Reported Outcome assessments.
5. Subject is 18-80 years old (inclusive).
Exclusion criteria
1. Subject received TKA on the contralateral knee as a revision for a
previously failed total or unicondylar knee arthroplasty.
2. Subject has a Body Mass Index (BMI) >= 40 at time of surgery.
3. Subject has ipsilateral hip arthritis resulting in flexion contracture.
4. At the time of enrolment, subject has one or more of the following
arthroplasties that are not fully healed and well-functioning, as determined by
the investigator: Ipsilateral or contralateral primary total hip arthroplasty
or hip resurfacing arthroplasty; Contralateral primary total knee or
unicondylar
knee arthroplasty.
5. Subject has a condition that may interfere with the TKA survival or outcome
(e.g. Paget*s or Charcot*s disease, vascular insufficiency, lupus, muscular
atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or
neuromuscular disease).
6. Subject has a known allergy to one or more of its components of the study
device.
7. Any subject with hardware present in distal femur or proximal tibia.
8. Any subject that meets the definition of a Vulnerable Subject per ISO 14155
Section 3.55.
9. Subject is entered in another drug, biologic, or device study or has been
treated with an investigational product in the past 30 days.
10. Subject, in the opinion of the Investigator, has an emotional or
neurological condition that would pre-empt their ability or willingness to
participate in the study including mental illness, drug or alcohol abuse.
11. Subject is known to be at risk for lost to follow-up, or failure to return
for scheduled visits.
12. Women who are pregnant, nursing, or of child-bearing potential who are not
utilizing highly effective birth control measures at the time of screening or
the time of surgery or do not engage in a sexual lifestyle that makes pregnancy
impossible (e.g. homosexual or are without a sexual partner).
13. Subjects who have participated previously in this clinical trial and who
have been withdrawn.
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 | NCT05197036 |
| CCMO | NL81198.000.23 |