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A Study to Evaluate the Conformis Hip System

R

restor3d

Status

Terminated

Conditions

Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System

Treatments

Device: Conformis Hip System

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

This is a prospective multicenter study. Subjects will be implanted with a Conformis Hip System. If the surgeon intraoperatively decides to use the Cordera femoral stem, these patients will also be enrolled in the study and tracked as a subset of the Conformis Hip System patient population.The study sites will be located in the United States. The study subjects will be followed for 10 years post implantation.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical condition included in the approved Indications For Use for the Conformis Hip System and the Cordera 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 Investigator 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 which precludes THR procedure
  • Immunocompromised in the opinion of the Investigator
  • 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 that is likely to confound results in the opinion of the Investigator
  • Physical disability affecting the lumbar spine that is likely to confound results in the opinion of the Investigator
  • 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

Trial contacts and locations

6

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Central trial contact

Marc Quartulli

Data sourced from clinicaltrials.gov

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