Alignment Techniques in TKA RCT
8. juni 2026 opdateret af: Jacob M. Elkins
Investigating Alignment Techniques in Total Knee Arthroplasty for Morbid Obese Patients: Randomize Control Trial.
The purpose of this research study is to compare two different methods used to align the knee during a total knee arthroplasty (TKA): technology-assisted inverse kinematic alignment, and manual-instrumented gap balancing alignment.
The first technique uses robotic or computer-assisted technology to help the surgeon place the knee implant based on the patient's individual anatomy, whereas the manual technique uses standard surgical instruments and manual methods to position and balance the knee implant during surgery.
The main difference is that one approach uses robotic or computer assistance to help guide implant positioning, while the other uses traditional instruments and manual surgical techniques.
Both methods are commonly used and are considered standard care.
The goal of this study is to understand whether one method results in better knee motion, function, and recovery after surgery in patients with higher body weight.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jacob Elkins, MD, PHD
- Telefonnummer: +1 319 335 7529
- E-mail: jacob-elkins@uiowa.edu
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Being an adult (age >= 18 years)
- Being indicated for Total Knee Arthroplasty (TKA) for the treatment of non-inflammatory knee osteoarthritis by the PI or sub-investigators.
- Having a body mass index (BMI) >= 35 kg/m2
Exclusion Criteria:
- Patients who are unable to provide written consent
- Being under-age (age < 18 years)
- Having a BMI < 35 kg/m2
- Having a non-elective TKA
- Having a diagnosis of secondary or inflammatory, rheumatic, psoriatic, osteoarthritis of the index knee
- Having a local or widespread infection
- Being pregnant - Women who become pregnant at any point throughout the research study will become excluded/ineligible and will immediately stop all study activities.
- Women who are capable of becoming pregnant and not currently on contraceptives will be excluded from this study because it will be difficult to obtain the weightbearing CT using the standard CT shield for pregnant women.
- Having had a previous open surgery of the index knee
- Presence of local or widespread infection
- Having a revision TKA
- Having a simultaneous bilateral TKA
- Not being able to safely conduct study procedures - If patients are wheelchair bound or require an assistive device to stand for 5 minutes, they will be excluded from this study.
- Non-English speakers
- Prisoners
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Technology-assisted inverse kinematic alignment
|
This technique uses robotic or computer-assisted technology to help the surgeon place the knee implant based on the patient's individual anatomy.
|
|
Aktiv komparator: Manual-instrumented gap balancing alignment
|
This manual technique uses standard surgical instruments and manual methods to position and balance the knee implant during surgery.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Range of motion
Tidsramme: From enrollment to the end of follow-up at 1 year after intervention.
|
From enrollment to the end of follow-up at 1 year after intervention.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
31. juli 2028
Studieafslutning (Anslået)
31. december 2029
Datoer for studieregistrering
Først indsendt
8. juni 2026
Først indsendt, der opfyldte QC-kriterier
8. juni 2026
Først opslået (Faktiske)
12. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202510443
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
This study will be using the OpenCap motion capture system to collect gait data of participants.
These recordings are stored in the OpenCap server and thus are shared with the OpenCap developers.
Participants can request the removal of these recordings.
IPD-delingstidsramme
Upon enrolling the first subject.
IPD-delingsadgangskriterier
Only the OpenCap developers will have access to the information.
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