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

Maxx Orthopedics

Status: Unknown

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

Treatments: Device: PEEK-Optima Femoral Component

Study type: Interventional

Funder types: Industry

Identifiers

NCT03224689

MI-001

Details and patient eligibility

About

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

Full 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

Enrollment: 34 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

PEEK Femoral

Experimental group

Description:

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.

Treatment:

Device: PEEK-Optima Femoral Component