Cemented vs Cementless in Bilateral TKA

Osteoarthritis Clinical Trial

Official title:

Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04496102
• Other study ID #: OrthoTU12
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 2021

Study information

• Verified date: July 2020
• Source: Thammasat University
• Contact: Supakit Kanitnate, M.D.
• Phone: +66899853635
• Email: naypeng[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.

Description:

To compare early functional outcomes, radiographic finding and operative time between cemented and cementless modern implant in sequential bilateral total kee arthroplasty.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA status 1 or 2

• Diagnosed with bilateral osteoarthritis of the knees

• Participant understand and consent to the protocol of the trial

Exclusion Criteria:

• Morbid obesity (BMI >40)

• Inflammatory arthritis

• Osteoporosis

• Metabolic bone disease

• Bone defect that seen from radiographs

Related Conditions & MeSH terms

• Osteoarthritis
• Total Knee Arthroplasty

Intervention

Device:
• Triathlon
Modern TKA design (Triathlon) with patellar resurfacing

Locations

Country	Name	City	State
Thailand	Thammasat University	Khlong Luang	Pathum Thani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare mean Forgotten joint score between 2 groups	The total score ranges from 0-100, where a high score is the best outcome	at 1 year
Secondary	Operative time		intra-operative assessment
Secondary	modified the Western Ontario and McMaster Universities Osteoarthritis Index score	The total score ranges from 0-96, where a high score is the worse outcome	post-op 2, 6 week, 3, 6, 12 month
Secondary	Pain level	VAS for pain (0-100)	Once daily 1-14 days after surgery then once a week until 3 months
Secondary	Range of knee motion	flexion and extension (degrees) which measured by long goniometer	post-op 2, 6 week, 3, 6, 12 month
Secondary	complication	such as fracture, infection, stiffness	until 1 year after surgery
Secondary	Radiological finding	Radiolucent line at femoral, tibial and patellar components which measured from radiolucent intervals (measured in millimetres) between the cement or prostheses and the bone according to the knee society total knee arthroplasty roentgenographic evaluation and scoring system	post-op 2, 6 week, 3, 6, 12 month