MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design

NCT06627673 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PK-00001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Knee Osteoarthritis

Keywords

Total Knee Replacement; Total Knee Arthroplasty; Polyether-ether-ketone

Outcome Measures

Primary Outcomes (1)

• Original Knee Society Score

  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. The Knee Society Score is usually reported as the two scores, "Knee Score" and "Function Score," rather than a summation score. The KSS score has a maximum of 100 points for each domain (Knee and Function).

  24 months post-treatment.

Secondary Outcomes (6)

• Knee Society Score (Knee Scores)

  Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment

• Knee Society Score (Function Scores)

  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)

  • 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

  • Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment

• Visual-Analog Scale (VAS) score

  Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment

Study Arms (1)

Treatment arm utilizing primary TKA with PEEK femoral component

EXPERIMENTAL

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.

Device: Total Knee Arthroplasty

Interventions

Total Knee Arthroplasty DEVICE

Primary Total Knee Arthroplasty with a PEEK femoral component

Also known as: Total Knee Replacement

Treatment arm utilizing primary TKA with PEEK femoral component

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maxx Orthopedics Inc: lead

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• Durbhakula SR, L. Restoration of Femoral Condylar Anatomy for Achieving Optimum Functional Expectations: Component Design and Early Results. Recon Review 6(3): 5, 2016

  BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.

  PMID: 18467932 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Asit Shah, MD, PhD

  Chief of Orthopedics - Englewood Hospital

  STUDY CHAIR

Central Study Contacts

Nach Dave, M.S., R.Ph.

CONTACT

732-718-1385; nach.dave@maxxortho.com

Corey Perine, BS, MBA

CONTACT

215-432-4323; corey.perine@maxxortho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 4, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share