Knee OsteoarthritisFAST-K IINCT06383936
FAldini Sport Total Joint Arthroplasty-Knee II
A study testing intensive rehabilitation after uncemented TKA in people with Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- intensive rehabilitation after uncemented TKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 26 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 40 and 65 years,
- both men and women,
- individuals who engaged in sports until knee pathology hindered them. - "Saltin-Grimby Physical Activity Level Scale" 3 or 4.
Who cannot join
- Patients with rheumatic and/or neuromuscular disorders.
- Patients with extreme knee deformity.
- Patients with secondary osteoarthritis with compromised bone quality.
- Patients with coronal knee instability.
- Pregnant patients.
- Patients with medical conditions or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Cesare Faldini, MD, 0516366 ext. 116, cesare.faldini@ior.it
About this study
Official title: FAldini Sport Total Joint Arthroplasty-Knee II: Toward Rehabilitation of Sports Activity Following Total Knee Arthroplasty
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.
Read the detailed 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"
- Conditions
- Knee Osteoarthritis
- Being tested
- intensive rehabilitation after uncemented TKA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive rehabilitation after uncemented TKAProcedure or surgery
patients undergoing an intensive rehabilitation protocol after uncemented tka
| Study group | Role | What they receive |
|---|---|---|
| TKA patients | Experimental | Not described Receives: Procedure: intensive rehabilitation after uncemented TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients returning to sports activities assessed by questionnaire
Measured: 1 year from the surgery
clinical and functional outcomes measured as the variation in the Knee Society Score
Measured: at 1, 3, 6 and 12 months from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start26 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383936
- Sponsor's protocol ID
- FAST-K II
- Acronym
- FAST-K II
- Status last verified
- May 2025
- First submitted
- 11 Apr 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAldini Sport Total Joint Arthroplasty-Knee II: Toward Rehabilitation of Sports Activity Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06383936
- Acronym / sponsor ID
- FAST-K II / FAST-K II
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 26 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKA patients | Experimental | Procedure: intensive rehabilitation after uncemented TKA |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between 40 and 65 years,
- both men and women,
- individuals who engaged in sports until knee pathology hindered them. - "Saltin-Grimby Physical Activity Level Scale" 3 or 4.
Key exclusion criteria (6 listed)
- Patients with rheumatic and/or neuromuscular disorders.
- Patients with extreme knee deformity.
- Patients with secondary osteoarthritis with compromised bone quality.
- Patients with coronal knee instability.
- Pregnant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive rehabilitation after uncemented TKApatients undergoing an intensive rehabilitation protocol after uncemented tka | Procedure or surgery | TKA patients |
Primary outcome
number of patients returning to sports activities assessed by questionnaire
Time frame: 1 year from the surgery
clinical and functional outcomes measured as the variation in the Knee Society Score
Time frame: at 1, 3, 6 and 12 months from the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive rehabilitation after uncemented TKA in people with Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients returning to sports activities assessed by questionnaire (time frame: 1 year from the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.