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

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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.


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
Nashville, Tennessee 37205
Principal Investigator: William Kurtz, MD
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Boynton Beach, Florida 33437
Principal Investigator: Gregory Martin
Phone: 561-733-5888
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Boynton Beach, FL
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Huntington, West Virginia 25702
Principal Investigator: Vivek Neginhal, MD
Phone: 304-525-6905
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Huntington, WV
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