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

Primary Purpose

Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Traumatic Arthritis of Knee (Diagnosis)

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

PEEK-Optima Femoral Component

About this trial

This is an interventional other trial for Osteoarthritis, Knee

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

More Institue, Department of Orthopedic SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEEK Femoral

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analog Scale (VAS)

Patient self administered overall satisfaction (scale from 1 worse -10 best)

SF-36

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)

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

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.

Full Information

NCT ID

NCT03224689

First Posted

July 18, 2017

Last Updated

July 13, 2021

Sponsor

Maxx Orthopedics Inc

1. Study Identification

Unique Protocol Identification Number

NCT03224689

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maxx Orthopedics Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PEEK Femoral

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

PEEK-Optima Femoral Component

Intervention Description

TKA Surgery

Primary Outcome Measure Information:

Title

Knee Society Score (KSS)

Description

Time Frame

Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

Secondary Outcome Measure Information:

Title

Visual Analog Scale (VAS)

Description

Patient self administered overall satisfaction (scale from 1 worse -10 best)

Time Frame

Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

Title

SF-36

Description

Time Frame

Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

Title

Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Description

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

Time Frame

Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

Title

Radiographic assessment

Description

Time Frame

Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Eberle

Phone

+1 (919) 280-6900

robert.eberle@maxxortho.com

First Name & Middle Initial & Last Name or Official Title & Degree

Corey Perine

Phone

+1 (484) 342-0092

Ext

2100

corey.perine@maxxortho.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Verdonk, MD, PhD

Organizational Affiliation

More Institute, Antwerp, Belgium

Official's Role

Principal Investigator

Facility Information:

Facility Name

More Institue, Department of Orthopedic Surgery

City

Antwerp

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Verdonk, MD, PhD

pverdonk@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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