Evaluation of The Safety And Performance of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component

A Multi-Centre Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component

Prospective, multi-centre, non-comparative, post-market surveillance clinical study

Study Overview

• Status: Recruiting
• Conditions: Fractures, Bone; Osteoarthritis, Knee; Rheumatoid Arthritis of Knee; Polyarthritis; Traumatic Arthritis of Knee (Diagnosis)
• Intervention / Treatment: Device: PEEK-Optima Femoral Component

Detailed Description

PRIMARY ENDPOINT:

• The primary endpoint is to evaluate the procedural success ie successful implantation of the device in the opinion of the surgeon

SECONDARY ENDPOINTS:

The secondary endpoints are to evaluate:

• KSS Knee scores and KSS Function scores at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
• Subject reported outcomes (SF-36, Oxford Knee Score and WOMAC) at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
• Stability of the device through radiographic analysis to assess alignment and component position at immediate post-treatment, 6 weeks, 6, 12 and 24 months post-treatment
• Safety in terms of adverse events and device deficiencies throughout the clinical investigation including any additional knee treatments and/or surgery
• Survivorship analysis of the device at 12 and 24 months and annually thereafter

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corey Perine; Phone Number: 2100 +1 (484) 342-0092; Email: corey.perine@maxxortho.com

Study Locations

• Belgium
  • Antwerp, Belgium
    • Recruiting
    • More Institue, Department of Orthopedic Surgery
    • Contact: Peter Verdonk, MD, PhD; Email: pverdonk@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

• Male and female subjects aged 50 years of age or older and less than 75 years of age (>50 and <75 years).
• Subjects who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator.
• Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis
• Subjects who, in the opinion of the Investigator, are able to 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 are able to 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 a BMI of 32 or above.
• 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 with a primary or secondary diagnosis of inflammatory or traumatic arthritis.
• Subjects defined by the Investigator as 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 a fixed flexion deformity of over 20 degrees.
• Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).
• Subjects who have previously undergone total or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, ORIF or with previous fracture in the ipsilateral knee joint.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PEEK Femoral; Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator will be invited to take part in this clinical investigation.	Device: PEEK-Optima Femoral Component; TKA Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score (KSS)	Pre-and post-operative function and patient and mechanical assessment. The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). The greater score correlates to better outcome.	Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Patient self administered overall satisfaction (scale from 1 worse -10 best)	Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
SF-36	Assessment domains to explain variations in patient outcomes. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Western Ontario and McMaster Universities Arthritis Index (WOMAC)	Assessment of OA of the knee or hip. Possible score range of 0- 20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function	Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Radiographic assessment	Subjective review and assessment of serial radiographs. Items include presence or absence of radiographic evidence of component loosening, malposition, migration and periprosthetic osteolysis, bone loss or interface composite (bone-cement-component) breakdown.	Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

Collaborators and Investigators

• Sponsor: Maxx Orthopedics Inc
• Investigators: Principal Investigator: Peter Verdonk, MD, PhD, More Institute, Antwerp, Belgium

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteoarthritis; Arthritis; Osteoarthritis, Knee; Fractures, Bone
• Other Study ID Numbers: MI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No