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

NCT ID: NCT03224689

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-03-01

Brief Summary

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

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

Conditions

Osteoarthritis, Knee; Rheumatoid Arthritis of Knee; Traumatic Arthritis of Knee (Diagnosis); Polyarthritis; Fractures, Bone

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PEEK-Optima Femoral Component

Intervention Type: DEVICE

TKA Surgery

Interventions

PEEK-Optima Femoral Component

TKA Surgery

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maxx Orthopedics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Verdonk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

More Institute, Antwerp, Belgium

Locations

More Institue, Department of Orthopedic Surgery

Antwerp, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Robert Eberle

Role: CONTACT

robert.eberle@maxxortho.com

+1 (919) 280-6900

Corey Perine

Role: CONTACT

corey.perine@maxxortho.com

+1 (484) 342-0092 ext. 2100

Facility Contacts

Peter Verdonk, MD, PhD

Role: primary

pverdonk@yahoo.com

Other Identifiers

MI-001

Identifier Type: -

Identifier Source: org_study_id