A Study to Evaluate the Conformis Hip System
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/14/2018 |
Start Date: | November 15, 2018 |
End Date: | October 15, 2030 |
Contact: | Marc Quartulli |
Email: | marc.quartulli@conformis.com |
Phone: | 7813459191 |
A Prospective, Multicenter Study to Evaluate the Conformis Hip System
This is a prospective, single arm, multicenter study. Subjects will be implanted with a
Conformis Hip System. The study sites will be located in the United States. The study
subjects will be followed for 10 years post implantation.
Conformis Hip System. The study sites will be located in the United States. The study
subjects will be followed for 10 years post implantation.
Inclusion Criteria:
- Clinical condition included in the approved Indications For Use for them Conformis Hip
System
- Osteoarthritis, as confirmed by the investigator's assessment of disease status at
screening visit that warrants a THR procedure
- Willingness to participate in the clinical study, to give informed consent, and to
attend all follow-up visits
- > 18 years of age
Exclusion Criteria:
- Simultaneous bilateral procedure required
- BMI > 40
- Poorly controlled diabetes (defined as HbA1c>7 or surgeon discretion)
- Crowe classification of hip dysplasia, grades 2, 3, or 4
- Active malignancy (defined as a history of any invasive malignancy - except
non-melanoma skin cancer), unless patient has been treated with curative intent and
there have been no clinical signs or symptoms of the malignancy for at least 5 years
- Other lower extremity surgery planned within 1 year of consent to the affected limb
Contralateral THR surgery within 3 months pre or post index surgery
- Neuromuscular conditions which prevent patient from participating in study activities
- Active local or systemic infection
- Immunocompromised
- Medically diagnosed fibromyalgia or similar conditions that might impact the patient's
ability to differentiate source of pain
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in
the area of the joint to be operated on, to an extent that the procedure is
unjustified
- Diagnosed with or receiving treatment for osteoporosis
- Charcot or Paget's disease
- Inability to complete the protocol in the opinion of the clinical staff due to safety
or other reasons
- Participation in another clinical study which would confound results
- Allergy to any of the implant materials
We found this trial at
3
sites
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Boynton Beach, Florida 33437
Principal Investigator: Gregory Martin
Phone: 561-733-5888
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Huntington, West Virginia 25702
Principal Investigator: Vivek Neginhal, MD
Phone: 304-525-6905
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