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

Not Applicable

• Conditions: Rheumatoid Arthritis of Knee; Traumatic Arthritis of Knee (Diagnosis); Fractures, Bone; Osteoarthritis, Knee; Polyarthritis
• Interventions: Device: PEEK-Optima Femoral Component

• Registration Number: NCT03224689
• Lead Sponsor: Maxx Orthopedics Inc

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

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Study Start: 2021-01-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-15
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEEK Femoral	PEEK-Optima Femoral Component	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
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.

Trial Locations

Locations (1)

More Institue, Department of Orthopedic Surgery; 🇧🇪 Antwerp, Belgium