Last updated: July 13, 2021
Sponsor: Maxx Orthopedics Inc
Overall Status: Active - Recruiting
Phase
N/A
Condition
Osteoporosis
Bone Density
Periodontitis
Treatment
N/AClinical Study ID
NCT03312088
MO-2017-PCK
Ages 40-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 surgerybased on aseptic loosening, infections, bone loss, MCL disruption, and/orperiprosthetic fractures.
- Patients who understand the conditions of the study and are willing and able to complywith the post-operative scheduled clinical and the prescribed rehabilitation.
- Subjects who, in the opinion of the Investigator, are able to understand this clinicalinvestigation, co-operate with the investigational procedures and are willing toreturn to the hospital for all the required post-operative follow-ups.
- Subjects who are able to give voluntary, written informed consent to participate inthis clinical investigation and from whom consent has been obtained.
Exclusion
Exclusion Criteria:
- Primary knee replacement of the affected knee joint
- Other significant disabling problems from the muscular-skeletal system than in theknees (i.e muscular dystrophy, polio, neuropathic joints)
- Obese patients where obesity is severe enough to affect subject's ability to performactivities of daily living.
- Patients who are found to be non-compliant by their physician
- Patients with or having; malignancy - active malignancy, active or suspected systemicinfection, Paget's disease, renal osteodystrophy, immunologically suppressed, sicklecell 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 theprescribed post-operative routine and follow-up evaluation schedule.
- Varus or valgus deformity > 20 degrees
- Bilateral TKR
Study Design
Total Participants: 300
Study Start date:
January 01, 2019
Estimated Completion Date:
February 28, 2022
Study Description
Connect with a study center
Coastal Orthopedics
Bradenton, Florida 34209
United StatesActive - Recruiting
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