Aseptic LooseningNCT03312088
Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship
An observational study of Aseptic Loosening and Infection, run by Maxx Orthopedics Inc at 1 site in United States.
Trial summary
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aseptic Loosening, Infection, Bone Loss
- What is being tested?
- Freedom Knee PCK Components
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to Feb 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
Who may be able to join
- Male and female subjects aged 40 years of age or older and less than 80 years of age (>40 and <80 years).
- Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
- 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.
- Subjects who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Who cannot join
- Primary 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, neuropathic joints)
- Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living.
- Patients who are found to be non-compliant by their physician
- Patients with or having; malignancy - active malignancy, active or suspected systemic 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
- Bilateral TKR
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Coastal Orthopedics
Bradenton, Florida, 34209
Mallory Simms, 941-792-1404 ext. 3450, msimms@coastalorthopedics.com
About this study
Official title: A Prospective, Multi-center, Single Arm Adaptive-design Study to Evaluate the Survivorship of the Maxx Orthopedics' PCK System in Revision Cases
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.
Read the detailed description
The clinical investigation is designed to be prospective to ensure that the population is representative of the type of population for which the Freedom Total Knee® System with the revision components is intended to treat. Subjects with a primary diagnosis of end-stage symptomatic revision knee who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a revision total knee arthroplasty, by the Investigator, will be invited to take part in this clinical investigation. Patients will be drawn from hospital clinics focusing on this type of treatment.
The treatment period of 36 months is considered sufficient to monitor the safety and clinical performance of the device. However, the patients will be contacted annually for 10 years or as long as the patient is willing to monitor their long-term progress.
An interim report will be issued when at least 120 patients will complete the 12-month follow-up.
No treatments will be withheld as part of this clinical investigation although any other treatments that need to be administered during the clinical investigation will be recorded.
- Conditions
- Aseptic Loosening, Infection, Bone Loss, MCL - Medial Collateral Ligament Rupture of the Knee, Periprosthetic Fractures
- Being tested
- Freedom Knee PCK Components
- Medical subject headings
- Infections, Bone Diseases, Metabolic, Periprosthetic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freedom Knee PCK ComponentsDevice
Total Knee Revision
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
"No Explants"
Measured: 36 months
Secondary outcomes (5)
Revision rates of any component (including insert) for any reason.
Revision rates of any component (including insert) for any reason.
Measured: 36 months
Revision rates of any component (including insert) for any reason except infection.
Revision rates of any component (including insert) for any reason except infection.
Measured: 36 months
KSS
Knee Society Score
Measured: 36 months
WOMAC
Pain Score
Measured: 36 months
ROM
Range of Motion
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start1 Jan 2019
- Primary completion1 Jan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aseptic LooseningStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxx Orthopedics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Cashin, MD, Principal investigator, Coastal Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312088
- Sponsor's protocol ID
- MO-2017-PCK
- Status last verified
- Jun 2021
- First submitted
- 12 Oct 2017
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single Arm Adaptive-design Study to Evaluate the Survivorship of the Maxx Orthopedics' PCK System in Revision Cases
- ClinicalTrials.gov ID
- NCT03312088
- Acronym / sponsor ID
- MO-2017-PCK
- Conditions
- Aseptic Loosening, Infection, Bone Loss, MCL - Medial Collateral Ligament Rupture of the Knee, Periprosthetic Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Maxx Orthopedics IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 17 Oct 2017 (actual)
- 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.
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.
Detailed description
The clinical investigation is designed to be prospective to ensure that the population is representative of the type of population for which the Freedom Total Knee® System with the revision components is intended to treat. Subjects with a primary diagnosis of end-stage symptomatic revision knee who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a revision total knee arthroplasty, by the Investigator, will be invited to take part in this clinical investigation. Patients will be drawn from hospital clinics focusing on this type of treatment.
The treatment period of 36 months is considered sufficient to monitor the safety and clinical performance of the device. However, the patients will be contacted annually for 10 years or as long as the patient is willing to monitor their long-term progress.
An interim report will be issued when at least 120 patients will complete the 12-month follow-up.
No treatments will be withheld as part of this clinical investigation although any other treatments that need to be administered during the clinical investigation will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
Key inclusion criteria (5 listed)
- Male and female subjects aged 40 years of age or older and less than 80 years of age (>40 and <80 years).
- Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
- 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.
- Subjects who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Key exclusion criteria (10 listed)
- Primary 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, neuropathic joints)
- Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living.
- Patients who are found to be non-compliant by their physician
- Patients with or having; malignancy - active malignancy, active or suspected systemic 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 Knee PCK ComponentsTotal Knee Revision | Device | – |
Primary outcome
Survivorship
Time frame: 36 months
"No Explants"
5 secondary outcomes
Revision rates of any component (including insert) for any reason.
Time frame: 36 months
Revision rates of any component (including insert) for any reason except infection.
Time frame: 36 months
KSS
Time frame: 36 months
WOMAC
Time frame: 36 months
ROM
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
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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.
David Cashin, MD principal investigator
Coastal Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aseptic Loosening and Infection, 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Eberle (+1 (919) 280-6900, robert.eberle@maxxortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship (time frame: 36 months). 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 15 Jul 2021.