Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06383936 |
| Other study ID # |
FAST-K II |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2024 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Istituto Ortopedico Rizzoli |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The majority of patients undergoing total knee arthroplasty are elderly individuals with low
functional demands, aiming to alleviate pain. However, there exists a subgroup of younger
patients, under the age of 65, with higher functional demands. The purpose of this study is
to evaluate the return to sports activities in this patient group following a non-cemented
total knee arthroplasty procedure and a specific rehabilitation protocol. The investigators
expect that with the use of non-cemented prostheses and a specific rehabilitation protocol,
many of these patients will safely resume sports activities.
Description:
Most of the patients requiring total knee arthroplasty (TKA) suffer from primary geriatric
osteoarthritis. These are predominantly elderly women, often overweight. According to the
2020 RIPO report, the average age of patients receiving primary bi- or tri-compartment knee
replacement implants is 70.5 years, with 70% being women, 84% suffering from primary
osteoarthritis; 40% are overweight, and 42% are obese. Generally, these individuals are frail
elderly with almost complete immobility due to arthritis; post-surgery, relieved of pain,
these patients typically return to very modest physical activity in terms of duration and
intensity.
However, there exists a wholly different subgroup. These are patients aged ≤65 years, often
men, who have been engaged in one or more sports activities since youth. Often, due to a
sports-related injury, patients present to orthopedic consultation at a much younger age,
with a severely arthritic condition, such as from ligamentous or meniscal trauma rendering
the knee less stable, yet these patients have continued to load it intensely during sports
activities. Literature and registry studies indicate that the incidence of TKA in this ≤65
age group has recently increased and is expected to rise further. Almost all of these
patients have an ambitious postoperative recovery expectation, aiming to return to sports
practice. This expectation is generally unmet today because the entire clinical pathway is
typically designed for the first subgroup described above, the elderly and frail.
With the use of cemented knee prostheses, which remain the most commonly adopted choice
worldwide, the overload on the implant leads to an increased incidence of aseptic loosening
at the prosthesis-cement interface. This results in poor clinical and functional outcomes in
the athletic patient subgroup and an increased failure rate, necessitating prosthetic
revision, which is even more invasive and costly. Modern uncemented TKAs involve initial
stable implant fixation through a robust press-fit mechanism of the component to bone and
additional pegs for added stability. Definitive biological stability is achieved around 12
weeks post-surgery through osseointegration at the prosthesis interface facilitated by highly
porous and/or hydroxyapatite-coated component surfaces.
Uncemented TKAs have shown undeniable advantages over the years, including reduced surgical
time (with consequent reduction in general and infection-related complications), preservation
of bone stock, and greater ease of performing prosthetic revision procedures. Additionally,
with next-generation uncemented prostheses, the problem of loosening at the interface has
significantly diminished, thanks to the use of biomaterials allowing firm implant fixation
over time, enabling a quicker and more efficient patient activity resumption with a lower
risk of prosthetic overload damage.
The long-term goal of this project is to explore whether and under what conditions it is
possible to envision a return to sports activity for individuals who have undergone TKA. This
type of intervention would constitute a form of tertiary prevention, aimed at containing and
controlling the complex outcomes of a pathology, in this case, the drastic reduction in
quality of life caused by the suspension of sports practice for this population subgroup. The
larger the affected population, the more significant the importance of tertiary prevention,
and thus the better the final outcome.
Regular physical activity is a well-known protective factor for the prevention and management
of non-communicable diseases. According to the latest WHO (World Health Organization)
guidelines from 2020, in adults (18-65 years), physical activity confers benefits for several
health outcomes, reducing overall mortality, cardiovascular disease mortality, incidence of
hypertension, breast and colon cancer, and type 2 diabetes onset. Physical activity also has
mental health benefits, delays dementia onset, can contribute to maintaining a healthy
weight, and overall well-being. It also helps prevent falls and fall-related injuries, as
well as slowing down bone health decline and functional capacity decline.
The aim of our study is to evaluate the clinical and functional outcomes in patients aged 40
to 65 undergoing uncemented TKA with functional alignment and subjected to an intensive
rehabilitation protocol aimed at returning to sports activity at the two orthopedic units,
"Orthopedic and Traumatological Clinic 1" and "Orthopedics-Traumatology and Prosthetic
Surgery and Hip and Knee Reimplantation"
