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Maxx Orthopedics' PCK Study

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ClinicalTrials.gov Identifier: NCT03312088
Recruitment Status : Not yet recruiting
First Posted : October 17, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Maxx Orthopedics Inc

Brief Summary:
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.

Condition or disease Intervention/treatment
Aseptic Loosening Infection Bone Loss MCL - Medial Collateral Ligament Rupture of the Knee Periprosthetic Fractures Device: Freedom Knee PCK Components

Detailed Description:

The clinical investigation is designed to be prospective to ensure that the population is representative of the type of population for which the Freedom Total Knee® System with the revision components is intended to treat. Subjects with a primary diagnosis of end-stage symptomatic revision knee who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a revision total knee arthroplasty, by the Investigator, will be invited to take part in this clinical investigation. Patients will be drawn from hospital clinics focusing on this type of treatment.

The treatment period of 36 months is considered sufficient to monitor the safety and clinical performance of the device. However, the patients will be contacted annually for 10 years or as long as the patient is willing to monitor their long-term progress.

An interim report will be issued when at least 120 patients will complete the 12-month follow-up.

No treatments will be withheld as part of this clinical investigation although any other treatments that need to be administered during the clinical investigation will be recorded.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-center, Single Arm Adaptive-design Study to Evaluate the Survivorship of the Maxx Orthopedics' PCK System in Revision Cases
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Intervention Details:
  • Device: Freedom Knee PCK Components
    Total Knee Revision


Primary Outcome Measures :
  1. Survivorship [ Time Frame: 36 months ]
    "No Explants"


Secondary Outcome Measures :
  1. Revision rates of any component (including insert) for any reason. [ Time Frame: 36 months ]
    Revision rates of any component (including insert) for any reason.

  2. Revision rates of any component (including insert) for any reason except infection. [ Time Frame: 36 months ]
    Revision rates of any component (including insert) for any reason except infection.

  3. KSS [ Time Frame: 36 months ]
    Knee Society Score

  4. WOMAC [ Time Frame: 36 months ]
    Pain Score

  5. ROM [ Time Frame: 36 months ]
    Range of Motion



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
Criteria

Inclusion Criteria:

  • Male and female subjects aged 40 years of age or older and less than 80 years of age (>40 and <80 years).
  • Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
  • Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and the prescribed rehabilitation.
  • 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:

  • Primary knee replacement of the affected knee joint
  • Other significant disabling problems from the muscular-skeletal system than in the knees (i.e muscular dystrophy, polio, neuropathic joints)
  • Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living.
  • Patients who are found to be non-compliant by their physician
  • Patients with or having; malignancy - active malignancy, active or suspected systemic infection, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia, and systemic lupus erythmatosus.
  • The patient has a neuromuscular or neurosensory deficit.
  • Female patients planning a pregnancy during the course of the study.
  • Patients, who are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
  • Varus or valgus deformity > 20 degrees
  • Bilateral TKR

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): NCT03312088


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

Sponsors and Collaborators
Maxx Orthopedics Inc

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Responsible Party: Maxx Orthopedics Inc
ClinicalTrials.gov Identifier: NCT03312088     History of Changes
Other Study ID Numbers: MO-2017-PCK
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: October 18, 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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Rupture
Periprosthetic Fractures
Wounds and Injuries
Fractures, Bone