Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System
NCT ID: NCT02056470
Last Updated: 2020-03-30
Study Results
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.
COMPLETED
NA
211 participants
INTERVENTIONAL
2013-09-30
2020-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. Range of Motion
2. Quality of Life measurements using Knee Society Scale (KSS)
3. Survivorship as defined by 'No Revision' of baseline implant
4. Quality of Life measurements using the WOMAC Score
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System
NCT06627699
Evaluation of The Safety And Performance of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
NCT03224689
Freedom® Total Knee System for Treatment of Osteoarthritis, Rheumatoid Arthritis or Post-traumatic Arthritis
NCT04033588
Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship
NCT03312088
Safety and Efficacy of the Journey II BCS Total Knee System
NCT01705067
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Freedom Total Knee Replacement
Freedom Total Knee
Freedom Total Knee
The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
Total Knee Replacement
total Knee replacement implant
Freedom Total Knee System
Total Knee replacement implant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Freedom Total Knee
The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
Total Knee Replacement
total Knee replacement implant
Freedom Total Knee System
Total Knee replacement implant
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients requiring knee prosthesis, and have been evaluated as appropriate candidates for aTKA by their orthopedic surgeon
* Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and the prescribed rehabilitation
Exclusion Criteria
* Other significant disabling problems from the muscular-skeletal system than in the knees (i.e muscular dystrophy, polio, nueropathic joints)
* Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI \> 35)
* Patients who are found to be non-compliant by their physician
* Patients with or having; malignancy - active malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia, and systemic lupus erythmatosus.
* The patient has a neuromuscular or neurosensory deficit.
* Female patients planning a pregnancy during the course of the study.
* Patients, who are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
* Varus or valgus deformity \> 20 degrees
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maxx Orthopedics Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert W Eberle
Role: STUDY_DIRECTOR
Director, Clinical Affairs
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Maxx Ortho
Norristown, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MO-U-101A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.