Comparison Between Brainlab Knee 3 Computer-assisted Navigation Systems and Conventional Instruments in TKA: a Prospective Cohort Study.
4. juli 2021 opdateret af: Peking University Third Hospital
Comparison of Accuracy and Clinical Outcomes Between Brainlab Knee 3 Computer-assisted Navigation Systems and Conventional Instruments in TKA: a Prospective Cohort Study
This is a a prospective cohort study.
According to the inclusion criteria, volunteers were recruited from patients undergoing total knee arthroplasty.
The patients are devided into two groups: the conventional TKA,the computer-assisted surgery(CAS) using Brainlab Knee 3 system.The differences of postoperative alignment,operative time,blood loss will be studied between the two groups.Clinical and functional evaluation using the scoring system of HSS(Hospital for Special Surgery) score, Western Ontario and McMaster University osteoarthritis index (WOMAC), Forgotten joint score(FJS-12) will be compared between the 2 groups,after surgery, and at the follow-up of 3 months、6 months and 12 months.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
According to the inclusion criteria, patients receiving primary total knee arthroplasty were recruited and divided into two groups after doctor-patient joint decision: the traditional group underwent prosthesis placement using traditional intramedullary positioning method;The navigation group performed surgery using the Brainlab Knee 3 navigation system.Informed consent was signed after grouping.
All patients were operated by the same knee prosthesis system.
Both groups underwent the same procedures such as the installation of the soft tissue adjustment, prosthesis placement, wound closure and so on.All patients were given the same perioperative treatment, such as hemostasis, anti-infection and analgesia, and routine postoperative rehabilitation exercises.
The full length anteroposterior and lateral radiographs of both lower extremities in weight-bearing position were taken preoperatively and one week postoperatively.The differences of postoperative alignment,operative time,blood loss will be studied between the two groups.Clinical and functional evaluation using the scoring system of HSS(Hospital for Special Surgery) score, Western Ontario and McMaster University osteoarthritis index (WOMAC), Forgotten joint score(FJS-12) will be compared between the 2 groups,after surgery, and at the follow-up of 3 months、6 months and 12 months.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
188
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Hua Tian
- Telefonnummer: 13511065187
- E-mail: tianhua@bjmu.edu.cn
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
40 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with knee osteoarthritis who underwent primary TKA
Beskrivelse
Inclusion criteria:
- Patients with knee osteoarthritis who underwent primary TKA;
- Informed consent has been signed and medical records are complete;
- No severe varus or valgus deformity of the knee (< 20°).
Exclusion criteria:
- Patients undergoing revision knee replacement;
- patients with rheumatoid arthritis and secondary knee osteoarthritis;
- Patients with severe valgus deformity(≥ 20°);
- Taking anticoagulant drugs for a long time in the past, or suffering from the following diseases: Renal insufficiency, liver insufficiency, severe heart disease (or coronary stent implantation within the last 12 months), severe respiratory disease, history of deep vein thrombosis in the lower extremities or a high risk of thrombosis (hereditary/acquired thrombosis), coagulation dysfunction, stroke, and malignancy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
The traditional group
The traditional group underwent prosthesis placement using traditional intramedullary positioning method.
|
|
|
The navigation group
The navigation group performed surgery using the Brainlab Knee 3 navigation system.Informed consent was signed after grouping.
|
Brainlab knee 3 navigation system is a kind of imageless computer-assisted navigation system.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
lower limb alignment
Tidsramme: Within 1 week after surgery
|
knee-ankle angle (HKA) and components placement using coronal femoral-component angle (CFA) and coronal tibia- component angle (CTA)、sagittal femoral-component angle (SFA) and sagittal tibia-component angle（STA）.
|
Within 1 week after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Operation time
Tidsramme: Immediately after surgery
|
Time from skin incision to wound closure.
|
Immediately after surgery
|
|
Blood loss
Tidsramme: 3 days after surgery
|
Postoperative drainage volume refers to the drainage volume of the affected knee within 24 hours after the end of surgery, accurate to ml.Gross linear equation was used to calculate the total blood loss and latent blood loss at 3 days after surgery.
|
3 days after surgery
|
|
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Tidsramme: 3 months、6 months and 12 months after surgery
|
The WOMAC is a self administered questionnaire to assess joint function and quality of life for patients with osteoarthritis; it consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items).
The higher the total score, the worse the patient's pain, stiffness, and functional limitations.
The WOMAC is validated for various languages, including Chinese.
|
3 months、6 months and 12 months after surgery
|
|
HSS(Hospital for Special Surgery) score
Tidsramme: 6 months and 12 months after surgery
|
HSS(hospital for special surgery) score HSS(hospital for special surgery) score to evaluate patients postoperative knee joint function.
With a total of 100, it has 7 subscales: 1.Pain 0~30; 2. Function 0~22; 3. Mobility 0~18; 4. Flexion deformity 0~10; 6. Stability 0~10; 7. Deduction Item.
For each scale, a higher value represents a better outcome.
The sum of the subscales is the total score.
|
6 months and 12 months after surgery
|
|
Forgotten Joint Score-12 (FJS-12)
Tidsramme: 6 months and 12 months after surgery
|
The FJS-12 is a PROM for patients who have undergone a TKA; it introduces the concept of a "forgotten" joint as the ideal objective to pursue in prosthetic surgery.
It is composed of 12 items, measuring the patient's ability to forget the presence of an artificial joint in their daily life.
For each item, there is a five-points Likert scale response.
The raw results are converted to a 0-100 points scale.
Highest score corresponds to good outcome with the patient not aware about the presence of the prosthesis.
In the case of more than 4 answers are missing, the score should not be used .
|
6 months and 12 months after surgery
|
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 (Forventet)
1. januar 2022
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
31. december 2023
Datoer for studieregistrering
Først indsendt
4. juli 2021
Først indsendt, der opfyldte QC-kriterier
4. juli 2021
Først opslået (Faktiske)
13. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juli 2021
Sidst verificeret
1. juli 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- navigation68480
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