Fractures, Bone, Osteoarthritis, Knee, Polyarthritis, Rheumatoid Arthritis of Knee, Traumatic Arthritis of Knee (Diagnosis)
Conditions
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
Interventions
DEVICEPEEK-Optima Femoral Component
TKA Surgery
Sponsors
Maxx Orthopedics Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score (KSS) | Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months | Patient self administered overall satisfaction (scale from 1 worse -10 best) |
| SF-36 | Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months | 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. |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months | 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 |
| Radiographic assessment | Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months | 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. |
Countries
Belgium
Contacts
Primary ContactRobert Eberle
Backup ContactCorey Perine
Outcome results
None listed