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

Overview

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.

Interventions

• Device Total Knee Arthroplasty
  Primary Total Knee Arthroplasty with a PEEK femoral component

Primary outcome measures

• Original Knee Society Score [Time frame: 24 months post-treatment.]

Secondary outcome measures (6)

• Knee Society Score (Knee Scores) [Time frame: Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment]
• Knee Society Score (Function Scores) [Time frame: Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment]
• Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) [Time frame: • Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment]
• The Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 [Time frame: • Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment]
• Visual-Analog Scale (VAS) score [Time frame: Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment]
• Forgotten Joint Score (FJS-12) [Time frame: Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 2 centers

• Ascentis — Leawood
• South Texas Bone and Joint — San Antonio

Publications

• Berend KR, Lombardi AV Jr, Mallory TH. Rapid recovery protocol for peri-operative care of total hip and total knee arthroplasty patients. Surg Technol Int. 2004;13:239-47. PMID 15744696
• Jamsen E, Puolakka T, Eskelinen A, Jantti P, Kalliovalkama J, Nieminen J, Valvanne J. Predictors of mortality following primary hip and knee replacement in the aged. A single-center analysis of 1,998 primary hip and knee replacements for primary osteoarthritis. Acta Orthop. 2013 Feb;84(1):44-53. doi: 10.3109/17453674.2012.752691. Epub 2012 Dec 17. PMID 23244785
• Durbhakula SR, L. Restoration of Femoral Condylar Anatomy for Achieving Optimum Functional Expectations: Component Design and Early Results. Recon Review 6(3): 5, 2016
• Durbhakula SD, V.; Durbhakula, N. Restoration of Femoral Condylar Anatomy for Achieving Optimum Functional Expectations: Continuation of an Earlier Study At 5-Year Minimum Follow-Up. Recon Review 9(1): 6, 2019
• Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4. PMID 2805470
• Lyman S, Lee YY, Franklin PD, Li W, Cross MB, Padgett DE. Validation of the KOOS, JR: A Short-form Knee Arthroplasty Outcomes Survey. Clin Orthop Relat Res. 2016 Jun;474(6):1461-71. doi: 10.1007/s11999-016-4719-1. Epub 2016 Feb 29. PMID 26926773
• Shim J, Hamilton DF. Comparative responsiveness of the PROMIS-10 Global Health and EQ-5D questionnaires in patients undergoing total knee arthroplasty. Bone Joint J. 2019 Jul;101-B(7):832-837. doi: 10.1302/0301-620X.101B7.BJJ-2018-1543.R1. PMID 31256677
• Thomsen MG, Latifi R, Kallemose T, Barfod KW, Husted H, Troelsen A. Good validity and reliability of the forgotten joint score in evaluating the outcome of total knee arthroplasty. Acta Orthop. 2016 Jun;87(3):280-5. doi: 10.3109/17453674.2016.1156934. Epub 2016 Mar 3. PMID 26937689

Identifiers

NCT: NCT06627673 · PK-00001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗