Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design

NCT ID: NCT01102829

Last Updated: 2010-04-13

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

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-04-30

Brief Summary

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

The aim of this study is to accurately assess the relationship between knee joint kinematics and migration of the tibial component of a high congruent, rotating platform total knee prosthesis by using fluoroscopy synchronised in time and space with a force plate, an external motion registration system and Electromyography (EMG).

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.

Rheumatoid Arthritis

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

PROSPECTIVE

Eligibility Criteria

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

Inclusion Criteria

* Patient is diagnosed with osteoarthritis and requiring primary arthroplasty
* Patient is capable of giving informed consent and expressing a willingness to comply with this study
* Patient has no major deformities
* The ability to perform a lunge and step-up motion without the help of bars or a cane.
* No or slight pain during activity according to the Knee Society Pain Score (Ewald, 1989; Insall et al., 1989)

Exclusion Criteria

* The patient is unable or unwilling to sign the Informed Consent specific to this study
* The individual has a functional impairment of any other lower extremity joint besides the operated knee
* Patient has a flexion contracture of more than 15°
* Patient has a varus/valgus contracture of more than 15°
* Patients requiring revision arthroplasty
* The patient does not understand the Dutch or English language good enough to participate.
* The use of walking aids
* The inability to walk more than 500 meters
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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

Leiden University Medical Center

Principal Investigators

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

Rob GH Nelissen, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Countries

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

Netherlands

Other Identifiers

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

ROCC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Computer Assisted Total Knee Replacement
NCT00279838 COMPLETED PHASE4