Cemented vs Cementless in Bilateral TKA

NCT ID: NCT04496102

Last Updated: 2020-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis Total Knee Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cemented TKA

Cemented TKA (Triathlon, Stryker) include patellar resurfacing

Group Type ACTIVE_COMPARATOR

Triathlon

Intervention Type DEVICE

Modern TKA design (Triathlon) with patellar resurfacing

Cementless TKA

Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing

Group Type EXPERIMENTAL

Triathlon

Intervention Type DEVICE

Modern TKA design (Triathlon) with patellar resurfacing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triathlon

Modern TKA design (Triathlon) with patellar resurfacing

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thammasat University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Supakit Kanitnate

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Thammasat University

Khlong Luang, Changwat Pathum Thani, Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Supakit Kanitnate, M.D.

Role: CONTACT

+66899853635

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

supakit kanitnate, M.D.

Role: primary

+66899853635

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OrthoTU12

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cemented vs. Cementless TKA
NCT04597684 TERMINATED NA