Primary Constrained Condylar Knee Arthroplasty Without Stem Extensions: Prevalence and Risk Factors

NCT ID: NCT03202225

Last Updated: 2017-12-21

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

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-17

Study Completion Date

2018-04-30

Brief Summary

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

While performing a primary TKA in consecutive patients, a constrained insert may be necessary when adequate stability and soft tissue balance are not obtained. In this retrospective study, The investigators aim to identify the prevalence and risk factors that associate with the use of a constrained insert in primary TKA.

Detailed Description

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

Conditions

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

Constrained Insert in Knee Arthroplasty

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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

constrained polyethylene

constrained polyethylene insert

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* primary knee osteoarthritis
* primary total knee replacement

Exclusion Criteria

* secondary knee osteoarthritis
* revision total knee replacement
* previous knee surgery
* post-traumatic knee
* history of previously infection
* comorbidity;rheumatoid arthritis, connective tissue disease, neuromuscular disease, lumbar spinal stenosis, neuropathy
* severe osteoporosis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Navamindradhiraj University

OTHER

Sponsor Role lead

Responsible Party

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

Satit Thiengwittayaporn

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Satit Thiengwittayaporn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Locations

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

Navamindradhiraj University

Dusit, Bangkok, Thailand

Site Status

Countries

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

Thailand

Other Identifiers

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

COA 61/2560

Identifier Type: -

Identifier Source: org_study_id