Clinical trial NCT04960345: Comparison Between Brainlab Knee 3 Computer-assisted Navigation Systems and Conventional Instruments in TKA: a Prospective Cohort Study.
Official title: Comparison of Accuracy and Clinical Outcomes Between Brainlab Knee 3 Computer-assisted Navigation Systems and Conventional Instruments in TKA: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Knee Arthroplasty
Keywords: Total knee arthroplasty
Lower limb alignment
Navigation
Functional outcomes
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 188
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with knee osteoarthritis who underwent primary TKA

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

1. Patients with knee osteoarthritis who underwent primary TKA;
2. Informed consent has been signed and medical records are complete;
3. No severe varus or valgus deformity of the knee (\< 20°).

Exclusion criteria:

1. Patients undergoing revision knee replacement;
2. patients with rheumatoid arthritis and secondary knee osteoarthritis;
3. Patients with severe valgus deformity(≥ 20°);
4. 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

Primary outcomes:
measure: lower limb alignment
timeFrame: Within 1 week after surgery
Secondary outcomes:
measure: Operation time
timeFrame: Immediately after surgery
measure: Blood loss
timeFrame: 3 days after surgery
measure: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 3 months、6 months and 12 months after surgery
measure: HSS(Hospital for Special Surgery) score
timeFrame: 6 months and 12 months after surgery
measure: Forgotten Joint Score-12 (FJS-12)
timeFrame: 6 months and 12 months after surgery
Other outcomes:
Locations:
Study officials:
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