Cemented vs Cementless in Bilateral TKA

Not Applicable

• Conditions: Osteoarthritis; Total Knee Arthroplasty

• Registration Number: NCT04496102
• Lead Sponsor: Thammasat University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2020-03-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-30
• Last Update Submitted: 2020-07-30
• Study First Posted: 2020-08-03
• Last Update Posted: 2020-08-03
• Primary Completion: 2020-12
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare mean Forgotten joint score between 2 groups	at 1 year	The total score ranges from 0-100, where a high score is the best outcome

Secondary Outcome Measures

Name	Time	Method
Radiological finding	post-op 2, 6 week, 3, 6, 12 month	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
Pain level	Once daily 1-14 days after surgery then once a week until 3 months	VAS for pain (0-100)
Operative time	intra-operative assessment
modified the Western Ontario and McMaster Universities Osteoarthritis Index score	post-op 2, 6 week, 3, 6, 12 month	The total score ranges from 0-96, where a high score is the worse outcome
complication	until 1 year after surgery	such as fracture, infection, stiffness
Range of knee motion	post-op 2, 6 week, 3, 6, 12 month	flexion and extension (degrees) which measured by long goniometer

Trial Locations

Locations (1)

Thammasat University; 🇹🇭 Khlong Luang, Pathum Thani, Thailand