Robotassisteret versus konventionelle knæendoprotetiske teknikker (ROCKETS)
RAKETTER: Robotstøttede versus konventionelle knæendoprotetiske teknikker i en randomiseret, multicenter, præferencetolerant undersøgelse
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Olof Sköldenberg, MD, PhD
- Telefonnummer: 46+700891253
- E-mail: olof.skoldenberg@ki.se
Studiesteder
-
-
-
Hässleholm, Sverige, 281 38
- Rekruttering
- Hässleholm Hospital
-
Stockholm, Sverige, 182 88
- Rekruttering
- Danderyd Hospital
-
Kontakt:
- Olof Skoldenberg, MD, PhD
- Telefonnummer: +46 8 123 572 45
- E-mail: olof.skoldenberg@ki.se
-
Ledende efterforsker:
- Olof Skoldenberg, MD, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Aktiv komparator: TKR
Conventional total knee arthroplasty (TKR). |
Conventional total knee arthroplasty using standard manual instrumentation according to local clinical routine. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants achieving a Forgotten Joint Score (FJS) ≥80 points
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Forgotten Joint Score (FJS), continuous score
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: During the index operation
|
Duration of the surgical procedure is recorded in minutes. |
During the index operation
|
|
Technical and intraoperative surgical outcomes
Tidsramme: During the index operation
|
Technical difficulties and prespecified intraoperative surgical details are recorded. |
During the index operation
|
|
Range of motion (ROM)
Tidsramme: 24 months after surgery
|
Knee range of motion is assessed at the 24-month follow-up. |
24 months after surgery
|
|
Reoperations and revisions
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2024DS
- Knee (Anden identifikator: Danderyds sjukhus)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .