A Study to Evaluate the Conformis Hip System

Stopped early

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

In brief

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.

Key facts

Study ID

NCT03738462

Run by

Restor3D

People needed

49

Starts

2018-11-26

Expected to finish

2022-06-06

Last updated by the study team

2023-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Orthopedic Specialty Center of Northern California — Roseville, California, United States
• Denver Hip and Knee — Parker, Colorado, United States
• Personalized Orthopedic Research Institute — Boynton Beach, Florida, United States
• Orthopaedic Institute of Henderson — Henderson, Nevada, United States
• Tennessee Orthopaedic Alliance — Nashville, Tennessee, United States
• Scott Orthopedic Center — Huntington, West Virginia, United States

Full record on ClinicalTrials.gov

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