Back to resultsEvaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System
Primary Purpose
Knee Joint Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Freedom Total Knee
Total Knee Replacement
Freedom Total Knee System
Sponsored by
About this trial
This is an interventional treatment trial for Knee Joint Pain
Eligibility 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
Sites / Locations
- Maxx Ortho
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Freedom Total Knee Replacement
Arm Description
Freedom Total Knee
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02056470
Brief Title
Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maxx Orthopedics Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
Range of Motion
Quality of Life measurements using Knee Society Scale (KSS)
Survivorship as defined by 'No Revision' of baseline implant
Quality of Life measurements using the WOMAC Score
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Joint Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
211 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Freedom Total Knee Replacement
Arm Type
Experimental
Arm Description
Freedom Total Knee
Intervention Type
Device
Intervention Name(s)
Freedom Total Knee
Other Intervention Name(s)
Freedom Total Knee System
Intervention Description
The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
Intervention Type
Device
Intervention Name(s)
Total Knee Replacement
Other Intervention Name(s)
Freedom Knee
Intervention Description
total Knee replacement implant
Intervention Type
Device
Intervention Name(s)
Freedom Total Knee System
Other Intervention Name(s)
Freedom Knee
Intervention Description
Total Knee replacement implant
Primary Outcome Measure Information:
Title
Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Eberle
Organizational Affiliation
Director, Clinical Affairs
Official's Role
Study Director
Facility Information:
Facility Name
Maxx Ortho
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System
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