Knee Joint PainNCT02056470
Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System
A study testing Freedom Total Knee, Total Knee Replacement and Freedom Total Knee System in people with Knee Joint Pain, run by Maxx Orthopedics Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Joint Pain
- What is being tested?
- Freedom Total Knee, Total Knee Replacement and Freedom Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
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.
- Conditions
- Knee Joint Pain
- Being tested
- Freedom Total Knee, Total Knee Replacement, Freedom Total Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freedom Total KneeDevice
Also called Freedom Total Knee System
The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
Total Knee ReplacementDevice
Also called Freedom Knee
total Knee replacement implant
Freedom Total Knee SystemDevice
Also called Freedom Knee
Total Knee replacement implant
| Study group | Role | What they receive |
|---|---|---|
| Freedom Total Knee Replacement | Experimental | Freedom Total Knee Receives: Device: Freedom Total Knee; Device: Total Knee Replacement; Device: Freedom Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxx Orthopedics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert W Eberle, Study director, Director, Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056470
- Sponsor's protocol ID
- MO-U-101A
- Status last verified
- Mar 2020
- First submitted
- 3 Feb 2014
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02056470
- Acronym / sponsor ID
- MO-U-101A
- Conditions
- Knee Joint Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Maxx Orthopedics IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2013 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Freedom Total Knee Replacement | Experimental | Device: Freedom Total Knee, Device: Total Knee Replacement, Device: Freedom Total Knee SystemFreedom Total Knee |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freedom Total KneeAlso: Freedom Total Knee SystemThe Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement | Device | Freedom Total Knee Replacement |
| Total Knee ReplacementAlso: Freedom Kneetotal Knee replacement implant | Device | Freedom Total Knee Replacement |
| Freedom Total Knee SystemAlso: Freedom KneeTotal Knee replacement implant | Device | Freedom Total Knee Replacement |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Eberle study director
Director, Clinical Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freedom Total Knee, Total Knee Replacement and Freedom Total Knee System in people with Knee Joint Pain, run by Maxx Orthopedics Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.