About the Study

Study Title

A Multi-Center, Prospective, Parallel Registry Controlled, Investigational Device Exemption Clinical Study to Determine Non-Inferiority of the PEEK-OPTIMA™ Femoral Component versus a Cobalt Chromium Alloy Femoral Component of Similar Design for Total Knee Arthroplasty
Sponsor
Maxx Orthopedics
Investigational Device
PEEK-OPTIMA™ femoral component (PEEK-OPTIMA™ Natural polymer from Invibio Biomaterials Solutions)

Study Overview

This study is a single arm, multi-center, prospective IDE trial. Approximately 200 patients recruited and consented will receive the PEEK femoral component and results will be compared to matched historic controls from the Maxx Orthopedics Freedom Total Knee System product registry. Male and female patients 18 years of age or older with Knee Society Score (KSS) of >25 and <75 will be eligible for enrollment.

Eligibility Criteria

Inclusion Criteria

  • Male and female subjects 18 years of age or older.

  • Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis.

  • Subjects with a pre-operative Knee Society Score (KSS) Knee score of >25 and <75.

  • Subjects 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 follow-ups.

  • Subjects who can give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

Exclusion Criteria

  • Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.

  • Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

  • Subjects who have participated in a clinical study with an investigational product in the last 6 months.

  • Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e.: muscular dystrophy, polio, neuropathic joints).

  • Subjects with known osteoporosis and/or previous history of fracture related to osteoporosis.

  • Subjects 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 erythematosus.

  • Subjects defined by the Investigator as American Society of Anesthesiologists (ASA) Grade III or IV.

  • Subjects who have a neuromuscular or neurosensory deficit.

  • Female subjects who are pregnant or lactating.

  • Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.

  • Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.

  • Subjects with a fixed flexion deformity of over 20 degrees.

  • Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).

  • Subjects who have previously undergone surgery on the indicated knee including total knee arthroplasty, patellofemoral arthroplasty, or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, fusion, open reduction and internal fixation.

Frequently Asked Questions

A clinical trial is a scientific study that tests the effectiveness of a treatment, a device or a drug. A trial could test, for example, the effectiveness of blood pressure medication in lowering blood pressure or whether a certain drug could decrease cholesterol.

It’s a way to help yourself and to help others. It provides an opportunity for you to help increase knowledge by helping researchers find out if a particular drug or therapy is safe and effective. While it is difficult to predict whether your condition will improve or how much it will improve, participation in a trial may be good for your health. It has been shown, for example, that even patients receiving the placebo, the inactive drug (see glossary of useful clinical terms) in clinical trials frequently do better than patients outside of the trials.

As a major academic medical center, UVA conducts hundreds of clinical trials at any moment. Trials to test drugs, devices or procedures for treatment of illnesses, such as kidney disease, diabetes, heart disease, brain injuries and so on are being conducted here. These trials have several things in common:

  • They are supervised by a principal investigator (see glossary).
  • They are sponsored by or supported by a researcher, a drug company or a government agency.
  • UVA may be one of many sites where the study is being conducted, or it may be the only site.

This depends on specific research goals of each trial. You must meet the requirements of the trial that you are interested in participating.

There are possible risks, such as adverse events or side effects, to consider when participating in any clinical trial. Participants are informed of known risks or side effects before starting the trial. Risks also are explained in the informed consent document. Make sure you fully understand them. There is always the possibility of unknown risk. If any new side effects or risks are discovered during the trial, you will be informed.

You must be fully informed, and consent to participate in a clinical trial. Informed consent involves a discussion between you and the investigator or research team member about what is involved in the trial, its purpose, risks, procedures, your compensation and who you should contact if you have questions. You are encouraged to ask questions during the discussion, so you understand what you are signing. Informed consent also requires you to sign and date the consent form.

UVA’s Institutional Review Board for Health Sciences Research (IRB-HSR) is comprised of healthcare professionals and members of the local community. The purpose of this committee is to monitor the safety and protect the rights of human research subjects — or participants in research. The committee continually reviews clinical trials developments and activities, and risks and benefits.

You may be paid a stipend and/or costs to cover mileage, travel time and meals. Participants may receive free medical care visits for the study, certain free medications, free diagnostic tests, laboratory procedures and free parking.

Once accepted in a trial, you will meet the principal clinical investigator, the healthcare provider who is responsible for the trial. Members of the research team you will see on a regular basis include the clinical trials coordinator(s) and research assistant(s).

Clinical trials vary in what they require of a subject, but typically,

  • You must make a commitment in time and be willing to follow the directions and instructions of the research team.
  • Periodic routine checks generally take a ½ hour to two hours. The number of visits and the length of the visits depend on the type of trial.

A typical trial proceeds in several phases:

1. A screening visit.

  • The informed consent is reviewed with you.
  • Blood is tested.
  • Your medical history is taken.
  • (Possibly) You have a physical exam to determine if you meet the trial’s requirements.

2. A baseline visit (may be combined with the screening visit).

3. Routine study visits are periodic visits throughout the study to test blood, administrate the study drug and check your condition.

4. Interim visits are added for unexpected problems or extra tests.

It depends on the trial; they can vary from days to a number of months or even years. You will be told the expected length of the trial before you start. This information is discussed with you during the informed consent process.

Usually, you are informed of the results of tests performed during the trial. You will always be informed of results that might influence your decision to remain or withdraw from the trial. Medical information may not be shared if the study is blinded (see glossary) or until the trial is completed.

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