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

Maxx Orthopedics Inc34 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

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

Interventions

PEEK-Optima Femoral ComponentDEVICE

TKA Surgery

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

More Institue, Department of Orthopedic Surgery

Antwerp, Belgium

RECRUITING

Outcomes

Primary Outcomes

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.