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OpenTrials
Completed

NCT Number: NCT02056470

Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System

Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial. Study endpoints include a comparison of Pre-Surgery versus Post-Surgery data for:

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

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Key information

Conditions

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maxx Ortho

Norristown, Pennsylvania, 19403, United States

About this study

The clinical study will involve a series of evaluations performed by your surgeon. These examinations are consistent with the normal surgeon care as part of Total Knee Replacement surgery. The study objective is to assess the safety, functionality, and survivorship of the Freedom Knee System through a multi-center clinical trial. Study endpoints include a comparison of Pre-Surgery (baseline) versus Post-Surgery data for Range of Motion and Flexion, Quality of Life (KSS), and survivorship (defined by 'no revisions'). Additionally, the structural integrity will be evaluated based on the x-ray performed 36-months after knee replacement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and Females 40-80 years of age
  • 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

  • Previous major knee replacement of the affected knee joint
  • 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

Treatment and study plan

Freedom Total Knee

Device

The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement

Other names: Freedom Total Knee System

Total knee replacement

Device

total Knee replacement implant

Other names: Freedom Knee

Freedom Total Knee System

Device

Total Knee replacement implant

Other names: Freedom Knee

Primary outcomes

  1. Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial

    Time frame: 3 years

    The study is hoping to assess the safety of the implant by looking at the incident of revisions to the implant post surgery up to and including 3 years

Sponsors and collaborators

Lead sponsor

Maxx Orthopedics Inc

Industry

Registry information

Official study title

A Prospective, Multicenter, Single Arm Adaptive-Design Study to Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2014
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.