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

NCT03224689 | Unknown DMC

• 1 other identifier: MI-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual Analog Scale (VAS)

  Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

• SF-36

  Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

• Radiographic assessment

  Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

Study Arms (1)

PEEK Femoral

EXPERIMENTAL

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

Interventions

PEEK-Optima Femoral Component DEVICE

TKA Surgery

PEEK Femoral

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Maxx Orthopedics Inc: lead

Study Sites (1)

More Institue, Department of Orthopedic Surgery

Antwerp, Belgium

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Disease; Arthritis; Fractures, Bone

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Peter Verdonk, MD, PhD

  More Institute, Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Eberle

CONTACT

+1 (919) 280-6900; robert.eberle@maxxortho.com

Corey Perine

CONTACT

+1 (484) 342-0092; corey.perine@maxxortho.com

Study Design

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

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)