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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Maxx Orthopedics Inc
Sponsor:
Information provided by (Responsible Party):
Maxx Orthopedics Inc
ClinicalTrials.gov Identifier:
NCT02056470
First received: February 3, 2014
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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

Condition Intervention
Knee Joint Pain
Device: Freedom Total Knee
Device: Total Knee Replacement
Device: Freedom Total Knee System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Maxx Orthopedics Inc:

Primary Outcome Measures:
  • Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Freedom Total Knee Replacement
Freedom Total Knee
Device: Freedom Total Knee
The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
Other Name: Freedom Total Knee System
Device: Total Knee Replacement
total Knee replacement implant
Other Name: Freedom Knee
Device: Freedom Total Knee System
Total Knee replacement implant
Other Name: Freedom Knee

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056470

Contacts
Contact: Corey Perine corey.perine@maxxortho.com

Locations
United States, Pennsylvania
Maxx Ortho Recruiting
Plymouth Meeting, Pennsylvania, United States
Contact: Corey Perine       corey.perine@maxxortho.com   
Maxx Ortho Recruiting
Plymouth Meeting, Pennsylvania, United States, 19462
Contact: Corey Perine       corey.perine@maxxortho.com   
Sponsors and Collaborators
Maxx Orthopedics Inc
  More Information

No publications provided

Responsible Party: Maxx Orthopedics Inc
ClinicalTrials.gov Identifier: NCT02056470     History of Changes
Other Study ID Numbers: MO-U-101A
Study First Received: February 3, 2014
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014