Techniki endoprotezoplastyki stawu kolanowego wspomagane robotem a konwencjonalne (ROCKETS)
Rakiety: wspomagane robotem a konwencjonalne techniki endoprotezoplastyki stawu kolanowego w randomizowanym, wieloośrodkowym badaniu uwzględniającym preferencje
Rationale for conducting the study:
The ROCKET study evaluates the clinical and economic outcomes of robot-assisted total knee arthroplasty (RTKR) compared with conventional total knee arthroplasty (TKR). The primary endpoint is the proportion of randomized participants achieving a Forgotten Joint Score (FJS) of ≥80 points at 24 months after surgery. Secondary outcomes include patient-reported knee function, health-related quality of life, self-reported instability, physical activity, radiographic alignment, surgical and technical outcomes, complications, reoperations, revisions, and health-economic outcomes.
Study design:
International multicentre, preference-tolerant, randomized, controlled superiority trial with two treatment arms comparing RTKR with conventional TKR. Participants in the randomized part are allocated 1:1. At selected centres where feasible, an optional participant-blinded randomized component may be implemented. Eligible patients who do not undergo randomization may participate in a parallel observational/preference cohort, which is analysed separately from the primary randomized comparison.
Study population:
Adults aged 18 years and older who are eligible for total knee arthroplasty according to local guidelines and who provide informed consent.
Number of patients:
Up to 1,600 randomized participants. Eligible non-randomized participants may additionally be included in the observational/preference cohort.
Primary outcome:
Proportion of randomized participants achieving FJS ≥80 points at 24 months after surgery.
Long-term follow-up:
Patient-reported and registry-based outcomes are planned at 5 and 10 years after surgery where feasible.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The ROCKET study is an international multicentre, prospective, preference-tolerant randomized controlled superiority trial comparing robot-assisted total knee arthroplasty with conventional total knee arthroplasty.
Participants in the randomized component are allocated 1:1 to robot-assisted or conventional total knee arthroplasty. Randomization is stratified by participating centre and sex. At selected centres where practical and approved, participants may remain blinded to treatment allocation until completion of the 24-month follow-up unless earlier unblinding is clinically required or requested by the participant. Surgeons and operating-room personnel cannot be blinded. Outcome assessment is performed blinded to treatment allocation whenever feasible.
Eligible patients who are unwilling to undergo randomization, or for whom treatment equipoise cannot be achieved, may enter a parallel observational/preference cohort. Treatment in this cohort follows patient and surgeon preference. The observational/preference cohort is analysed separately from the primary randomized comparison.
The primary endpoint is the proportion of randomized participants achieving a Forgotten Joint Score (FJS) of ≥80 points at 24 months after surgery. Follow-up includes patient-reported outcomes, activity, radiographic alignment, surgical and technical variables, complications, reoperations, revisions and health-economic outcomes. Long-term follow-up is planned at 5 and 10 years after surgery, including PROMs where available and registry-based outcomes such as reoperations, revisions, complications and mortality.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Olof Sköldenberg, MD, PhD
- Numer telefonu: 46+700891253
- E-mail: olof.skoldenberg@ki.se
Lokalizacje studiów
-
-
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Hässleholm, Szwecja, 281 38
- Rekrutacyjny
- Hässleholm Hospital
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Stockholm, Szwecja, 182 88
- Rekrutacyjny
- Danderyd Hospital
-
Kontakt:
- Olof Skoldenberg, MD, PhD
- Numer telefonu: +46 8 123 572 45
- E-mail: olof.skoldenberg@ki.se
-
Główny śledczy:
- Olof Skoldenberg, MD, PhD
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Adults aged 18 years and older.
- Eligible for total knee arthroplasty according to local guidelines and routines.
- Willingness to participate in the study.
Exclusion Criteria:
- Patients with extreme malalignment necessitating special implants or techniques.
- Patients unfit for surgery due to other medical reasons.
- Patients who, for other reasons such as alcohol or substance abuse, are deemed unsuitable to participate in the study.
- Patients who, for other reasons, cannot fulfil the required patient-reported outcome measures.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: RTKR
Robot-assisted total knee arthroplasty (RTKR). |
Robot-assisted total knee arthroplasty using an approved robotic surgical system to assist intraoperative planning, bone preparation, implant positioning and balancing according to the participating centre's approved technique. |
|
Aktywny komparator: TKR
Conventional total knee arthroplasty (TKR). |
Conventional total knee arthroplasty using standard manual instrumentation according to local clinical routine. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of participants achieving a Forgotten Joint Score (FJS) ≥80 points
Ramy czasowe: 24 months after surgery
|
The primary endpoint is the proportion of randomized participants achieving an FJS of ≥80 points at 24 months after surgery. The FJS ranges from 0 to 100, with higher scores indicating less awareness of the replaced knee during everyday activities. |
24 months after surgery
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Forgotten Joint Score (FJS), continuous score
Ramy czasowe: Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
FJS is scored from 0 to 100, with higher scores indicating less awareness of the replaced knee. |
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
|
Knee injury and Osteoarthritis Outcome Score (KOOS)
Ramy czasowe: Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
KOOS assesses knee-related pain, symptoms, activities of daily living, sport/recreation and knee-related quality of life. Each subscale ranges from 0 to 100, with higher scores indicating better outcome. |
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
|
Self-reported knee instability (ADLS items)
Ramy czasowe: Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
Self-reported slipping/partial giving way and buckling/full giving way are assessed using items from the Activities of Daily Living Scale of the Knee Outcome Survey. |
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
|
EQ-5D and EQ VAS
Ramy czasowe: Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
Health-related quality of life is assessed using EQ-5D and EQ VAS. |
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
|
Patient activity and walking distance
Ramy czasowe: Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
Patient activity and walking distance are assessed during follow-up using the study's prespecified activity measurements. |
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
|
Knee alignment
Ramy czasowe: Preoperative and approximately 6 weeks after surgery
|
Coronal knee alignment is assessed using long-standing radiographs, including Hip-Knee-Ankle alignment and Coronal Plane Alignment of the Knee (CPAK) classification. |
Preoperative and approximately 6 weeks after surgery
|
|
Surgery time
Ramy czasowe: During the index operation
|
Duration of the surgical procedure is recorded in minutes. |
During the index operation
|
|
Technical and intraoperative surgical outcomes
Ramy czasowe: During the index operation
|
Technical difficulties and prespecified intraoperative surgical details are recorded. |
During the index operation
|
|
Range of motion (ROM)
Ramy czasowe: 24 months after surgery
|
Knee range of motion is assessed at the 24-month follow-up. |
24 months after surgery
|
|
Reoperations and revisions
Ramy czasowe: Up to 24 months, with additional follow-up at 5 and 10 years
|
Reoperations and revisions of the index knee are recorded during the primary study period and assessed during long-term follow-up where data are available. |
Up to 24 months, with additional follow-up at 5 and 10 years
|
|
Adverse events and complications
Ramy czasowe: Up to 24 months, with additional long-term assessment at 5 and 10 years
|
Adverse events and complications related to the index knee arthroplasty are recorded. Long-term complications may additionally be assessed using approved registry or other data sources. |
Up to 24 months, with additional long-term assessment at 5 and 10 years
|
|
Mortality
Ramy czasowe: 90 days, 1 year, 5 years and 10 years after surgery
|
Mortality is assessed using available approved registry or other data sources. |
90 days, 1 year, 5 years and 10 years after surgery
|
|
Health-economic outcomes
Ramy czasowe: Up to 24 months; exploratory long-term analyses at 5 and 10 years where data are available
|
Health-economic analyses include direct and indirect costs and cost-effectiveness using health-related quality-of-life data. |
Up to 24 months; exploratory long-term analyses at 5 and 10 years where data are available
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2024DS
- Knee (Inny identyfikator: Danderyds sjukhus)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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