An observational study in Knee Osteoarthristis and Total Knee Anthroplasty, sponsored by Maxx Orthopedics Inc. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Maxx Orthopedics Inc · Observational
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.
To maintain equal site distribution per device, patient recruitment will include up to a total of twenty (20) registry sites and thirty (30) primary TKA candidates per site / surgeon for a total of 600 registry patients. A total of no more than 200 patients across all sites will be recruited per level of constraint (e.g.: 200 CR, 200:PS, 200:UC) for this registry with a 10-month accrual target from study initiation per site (\~3 patients consented / month).
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.
The registry population will consist of adult male and female subjects who are suffering from moderate to severe symptoms of the following diagnoses: painful degenerative knee disease.
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.
Candidates for this registry must meet ALL of the following criteria:
EXCLUSION CRITERIA:
Candidates will be excluded from the evaluation if ANY of the following apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TARGETED PATIENTS Adult male and female patients greater than 18 years of age Candidate for primary TKA GENERAL EXCLUSIONS Active infection Revision / conversion TKA (Prior UKA or HTO)
Device: Total Knee Arthroplasty
Post-Market Surveillance of the Freedom Total Knee System for Primary TKA
Device Survivorship
Revision / re-operation post-operatively due to device / device composite failure. An anticipated benefit of the device is that it is more conforming at higher degrees of flexion, which could potentially result in reduced polyethylene wear and improved survivorship over the longer-term. To assess this aspect of the device in addition to safety over the short-, intermediate- and long-term, survivorship analyses will be conducted at the targeted follow-up landmark timepoints. There will be 3 survivorship endpoints: * Revision of any component (including insert) for any reason * Revision of any component (including insert) for any reason except infection
Time frame: 2 years
Original Knee Society Scale (KSS)
The Knee Society Score rating system was first introduced during the late 1980's and has become the standard clinical evaluation system for reporting results for patients undergoing Total Knee Arthroplasty. Most major journals strongly encourage that total knee manuscripts include Knee Society Score rating scores as part of the result section. The Knee Society Score consists of points given for pain, range of motion, and stability. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.
Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)
The KOOS-JR is self-administered and assesses three domains: stiffness (1 question), pain (4 questions), function / daily living (2 questions). The KOOS-JR meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. Each item (questions) is coded from 0 to 4. The raw responses are summed (0-28) which is then converted to an interval score based on the KOOS-JR conversion table. The score is a percentage score from 0 to 100, 0 representing total knee disability and 100 representing perfect knee health.
Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
Patient Reported Outcomes Measurement Information System (PROMIS Global-10)
The Patient Reported Outcomes Measurement Information System (PROMIS Global-10) is a valid and reliable patient assessment and consists of ten (10) items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life. The response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. The PROMIS 10 scores are predictive of healthcare utilization, mortality in general and disease-specific clinical populations.
Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
Visual Analog Scale (VAS)
This scale has been designed to give subjective pain information as to the degree of knee pain you the patient is currently experiencing. VAS scoring is included in the PROMIS GLOBAL-10 assessment and is not necessary to collect a separate assessment. Applying the VAS, the patient will select a number from 1 (no pain) to 10 (maximum pain) that most closely describes their current pain.
Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
Forgotten Joint Score (FJS-12)
The 12 question Forgotten Joint Score (FJS-12) was introduced with the aim of assessing the patients 'joint awareness'. The authors of the score suggest the "higher the score" is more representative of higher-level function after surgery, as to be able to forget about the joint requires the absence of pain and the ability to perform all desired functional tasks without limitation.
Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
Radiography (plain-film radiography as per standard of care - independent collective site assessment)
* Evidence of correct component position * Evidence of stable component fixation * Review of incidence and location of any lucencies, sclerotic lines, component subsidence and/or osteolysis
Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
Adverse Events
* Local (wound and skin) * Systemic (infection markers) * Clinical / radiographic evidence of component / composite failure * Unscheduled re-visit or re-operation within 24 months post-operatively.
Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
Plan to share: Undecided — Proprietary nature of data for use for FDA De-Novo Submission following study conclusion.
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Maxx Orthopedics Inc