Clinical trial NCT06627673: MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
Official title: MultiCenter Prospective Parallel Registry Controlled Investigational Device Exemption Clinical Study to Determine Non-Inferiority of the PEEK-OPTIMA™ Femoral Component Versus a CoCr Alloy Femoral Component of Similar Design for TKA
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total Knee Replacement
Total Knee Arthroplasty
Polyether-ether-ketone
Lead sponsor: Maxx Orthopedics Inc
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a single arm, multi-center, prospective IDE trial. Two hundred (200) patients recruited and consented will receive the PEEK-OPTIMA™ Femoral Component and results will be compared to matched historic controls from the Maxx Orthopedics Freedom Total Knee System product registry (PK-00002 REV-01, WCG IRB# 20241890). Male and female patients 18 years of age or older with Knee Society Score (KSS) of \>25 and \<75 will be eligible for enrollment.
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

Detailed description: 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).

PEEK is a high-performance, engineering thermoplastic characterized by an unusual combination of properties. These properties range from high temperature performance to mechanical strength and excellent chemical resistance.

The PEEK-OPTIMA® femoral component, is an investigational device and is the subject of this study approved for IDE by the Federal Food and Drug Administration (FDA).

Maxx Orthopedics, Freedom Total Knee System is used with instrumentation to assist with surgery of the knee. The Maxx Orthopedics, Freedom Total Knee System implants are approved by the FDA for use in the United States and is not investigational.

All patients will receive the Freedom Total Knee System with the PEEK femoral component. Patient / study participents' records will be reviewed for identification of any and all complications, post-operative care, component safety and efficacy, and if re-operation is needed.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 18 years of age or older.
* Subjects with a primary diagnosis of end-stage symptomatic unilateral 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.
* Subjects 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.

Primary outcomes:
measure: Original Knee Society Score
timeFrame: 24 months post-treatment.
Secondary outcomes:
measure: Knee Society Score (Knee Scores)
timeFrame: Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment
measure: Knee Society Score (Function Scores)
timeFrame: Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment
measure: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)
timeFrame: • Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment
measure: The Patient Reported Outcomes Measurement Information System (PROMIS) Global-10
timeFrame: • Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment
measure: Visual-Analog Scale (VAS) score
timeFrame: Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment
measure: Forgotten Joint Score (FJS-12)
timeFrame: Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Chief of Orthopedics - Englewood Hospital
name: Asit Shah, MD, PhD
role: STUDY_CHAIR
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