Comparison Between Brainlab Knee 3 Computer-assisted Navigation Systems and Conventional Instruments in TKA: a Prospective Cohort Study.
4 juillet 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
188
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Hua Tian
- Numéro de téléphone: 13511065187
- E-mail: tianhua@bjmu.edu.cn
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients with knee osteoarthritis who underwent primary TKA
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
lower limb alignment
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Operation time
Délai: Immediately after surgery
|
Time from skin incision to wound closure.
|
Immediately after surgery
|
|
Blood loss
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 janvier 2022
Achèvement primaire (Anticipé)
31 décembre 2022
Achèvement de l'étude (Anticipé)
31 décembre 2023
Dates d'inscription aux études
Première soumission
4 juillet 2021
Première soumission répondant aux critères de contrôle qualité
4 juillet 2021
Première publication (Réel)
13 juillet 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 juillet 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 juillet 2021
Dernière vérification
1 juillet 2021
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- navigation68480
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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