CClinicalTrials.gg
Status unknownNCT03312088Updated Jul 15, 2021

Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship

An observational study in Aseptic Loosening, Infection and Bone Loss, sponsored by Maxx Orthopedics Inc. Status unknown at 1 site in United States. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-15.

Sponsored by Maxx Orthopedics Inc · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
40 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Aseptic Loosening
  • Infection
  • Bone Loss
  • MCL - Medial Collateral Ligament Rupture of the Knee
  • Periprosthetic Fractures

Browse trials for

03

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • DeviceFreedom Knee PCK Components

    Total Knee Revision

05

What researchers measure

Primary outcomes

  1. Survivorship

    "No Explants"

    Time frame: 36 months

Secondary outcomes

  1. Revision rates of any component (including insert) for any reason.

    Revision rates of any component (including insert) for any reason.

    Time frame: 36 months

  2. Revision rates of any component (including insert) for any reason except infection.

    Revision rates of any component (including insert) for any reason except infection.

    Time frame: 36 months

  3. KSS

    Knee Society Score

    Time frame: 36 months

  4. WOMAC

    Pain Score

    Time frame: 36 months

  5. ROM

    Range of Motion

    Time frame: 36 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03312088
Lead sponsor
Maxx Orthopedics Inc
Responsible party
Sponsor
First posted
Oct 17, 2017
Start date
Jan 1, 2019
Primary completion
Jan 1, 2022 (estimated)
Completion
Feb 2022 (estimated)
Last update
Jul 15, 2021

Study contacts

Robert Eberle
Contact
robert.eberle@maxxortho.com
+1 (919) 280-6900
Coreyn Perine
Contact
corey.perine@maxxortho.com
+1 (484) 342-0092
David Cashin, MD
principal investigator · Coastal Orthopedics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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