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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

Tracking Information
First Submitted Date  ICMJE July 18, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date October 13, 2017
Estimated Study Start Date  ICMJE January 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
Knee Society Score (KSS) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03224689 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
Official Title  ICMJE A Multi-Centre Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Osteoarthritis, Knee
  • Rheumatoid Arthritis of Knee
  • Traumatic Arthritis of Knee (Diagnosis)
  • Polyarthritis
  • Fractures, Bone
Intervention  ICMJE Device: PEEK-Optima Femoral Component
TKA Surgery
Study Arms  ICMJE Experimental: PEEK Femoral
Intervention: Device: PEEK-Optima Femoral Component
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2017)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Gabriela Gottlieb, MPH 2156067418 Gabriela.Gottlieb@maxxortho.com
Contact: Kevin Phelps Kevin.Phelps@maxxortho.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03224689
Other Study ID Numbers  ICMJE MI-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maxx Orthopedics Inc
Study Sponsor  ICMJE Maxx Orthopedics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Kurth, MD Asklepios Klinik Birkenwerder Betriebsstätte der Asklepios Klinik Wiesbaden GmbH
PRS Account Maxx Orthopedics Inc
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP