Cemented vs Cementless in Bilateral TKA

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04496102

Enrollment

Registered

2020-08-03

Start date

2020-03-01

Completion date

2021-03-31

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Total Knee Arthroplasty

Keywords

cemented, cementless, total knee arthroplasty, short term outcome, functional outcome

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.

Interventions

DEVICETriathlon

Modern TKA design (Triathlon) with patellar resurfacing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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	—
complication	until 1 year after surgery	such as fracture, infection, stiffness
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
Range of knee motion	post-op 2, 6 week, 3, 6, 12 month	flexion and extension (degrees) which measured by long goniometer

Countries

Thailand

Contacts

Primary ContactSupakit Kanitnate, M.D.

naypeng@hotmail.com+66899853635

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026