Clinical trial NCT03224689: Evaluation of The Safety And Performance of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
Official title: A Multi-Centre Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Rheumatoid Arthritis of Knee
Traumatic Arthritis of Knee (Diagnosis)
Polyarthritis
Fractures, Bone
Lead sponsor: Maxx Orthopedics Inc
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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.

Primary outcomes:
measure: Knee Society Score (KSS)
timeFrame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
measure: SF-36
timeFrame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
measure: Radiographic assessment
timeFrame: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: More Institue, Department of Orthopedic Surgery
Study officials:
affiliation: More Institute, Antwerp, Belgium
name: Peter Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: