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A Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component

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ClinicalTrials.gov Identifier: NCT03224689
Recruitment Status : Not yet recruiting
First Posted : July 21, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Maxx Orthopedics Inc

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Rheumatoid Arthritis of Knee Traumatic Arthritis of Knee (Diagnosis) Polyarthritis Fractures, Bone Device: PEEK-Optima Femoral Component Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEEK Femoral Device: PEEK-Optima Femoral Component
TKA Surgery




Primary Outcome Measures :
  1. Knee Society Score (KSS) [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224689


Contacts
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Contact: Gabriela Gottlieb, MPH 2156067418 Gabriela.Gottlieb@maxxortho.com
Contact: Kevin Phelps Kevin.Phelps@maxxortho.com

Sponsors and Collaborators
Maxx Orthopedics Inc
Investigators
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Principal Investigator: Andreas Kurth, MD Asklepios Klinik Birkenwerder Betriebsstätte der Asklepios Klinik Wiesbaden GmbH

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Responsible Party: Maxx Orthopedics Inc
ClinicalTrials.gov Identifier: NCT03224689     History of Changes
Other Study ID Numbers: MI-001
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteoarthritis, Knee
Fractures, Bone
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries