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Compares treatment options for Knee Osteoarthritis
Official title MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
ClinicalTrials.gov ID: NCT06627673
What this study is testing
- What it's testing
- The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female people 18 years of age or older.
- people with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis.
- people with a pre-operative Knee Society Score (KSS) Knee score of \>25 and \<75.
- people who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are...
- people who can give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
You likely can't join if
- people who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical...
- people who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- people who have participated in a clinical study with an investigational product in the last 6 months.
- people with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e.: muscular dystrophy, polio...
- people with known osteoporosis and/or previous history of fracture related to osteoporosis.
- people with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically...
See the full eligibility criteria
- Male and female people 18 years of age or older.
- people with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis.
- people with a pre-operative Knee Society Score (KSS) Knee score of \>25 and \<75.
- people who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative...
- people who can give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- people who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- people who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- people who have participated in a clinical study with an investigational product in the last 6 months.
- people with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e.: muscular dystrophy, polio, neuropathic joints).
- people with known osteoporosis and/or previous history of fracture related to osteoporosis.
- people with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus...
- people defined by the Investigator as American Society of Anesthesiologists (ASA) Grade III or IV.
- people who have a neuromuscular or neurosensory deficit.
- Female people who are pregnant or lactating.
- people with an anatomical limb alignment of above 20 degrees varus or valgus.
- people with primary or secondary diagnosis of inflammatory or traumatic arthritis.
- people with a fixed flexion deformity of over 20 degrees.
- people with recurvatum (definition: hyperextension ≥ 5 degrees).
- people who have previously undergone surgery on the indicated knee including total knee arthroplasty, patellofemoral arthroplasty, or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction...
- people that have undergone, or scheduled to undergo, contralateral total knee arthroplasty or unicondylar knee arthroplasty within ±1 year from the study surgical procedure.
- Evidence of active or suspected (systemic or local) infection at time of surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Leawood, Kansas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leawood, Kansas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.