ClinicalTrials.gg
Sign In
CompletedNCT02056470Updated Mar 30, 2020

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

An interventional study of Freedom Total Knee and Total Knee Replacement in Knee Joint Pain, sponsored by Maxx Orthopedics Inc. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by Maxx Orthopedics Inc · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2013, registered Feb 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
211
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
All
01

Study summary

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
Read the detailed description

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.

02

Conditions studied

  • Knee Joint Pain
03

In context

Lead sponsor

Maxx Orthopedics Inc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
211 participants (actual)

Study arms

  • Experimental
    Freedom Total Knee Replacement

    Freedom Total Knee

    Device: Freedom Total Knee · Device: Total Knee Replacement · Device: Freedom Total Knee System

Interventions

  • DeviceFreedom Total Knee

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

    Also known as: Freedom Total Knee System

  • DeviceTotal Knee Replacement

    total Knee replacement implant

    Also known as: Freedom Knee

  • DeviceFreedom Total Knee System

    Total Knee replacement implant

    Also known as: Freedom Knee

06

What researchers measure

Primary outcomes

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

    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

    Time frame: 3 years

07

Study locations

1 site
  • Maxx Ortho
    Norristown, Pennsylvania 19403, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2013 to primary completion in Feb 2020, 77 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 3, 2014
First posted
Feb 6, 2014
StartActual
Sep 2013
Primary completionActual
Feb 2020
CompletionActual
Mar 2020
Last update
Mar 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02056470
Lead sponsor
Maxx Orthopedics Inc
Responsible party
Sponsor
First posted
Feb 6, 2014
Start date
Sep 2013
Primary completion
Feb 2020
Completion
Mar 2020
Last update
Mar 30, 2020

Study contacts

Robert W Eberle
study director · Director, Clinical Affairs

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Maxx Orthopedics Inc

Start the discussion