NCT03738462

A Study to Evaluate the Conformis Hip System

A Prospective, Multicenter Study to Evaluate the Conformis Hip System

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Restor3D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Conformis Hip System	The Conformis Hip System is an FDA cleared, uncemented, primary total hip replacement device composed of femoral and acetabular components. The system incorporates the use of a pre-operative CT scan to design patient-specific implants and instruments. Using patient imaging (CT scan), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. In addition, each Conformis Hip System device is shipped with an additional (optional) femoral stem (Cordera Femoral Stem).

Timeline

• Start date: 2018-11-26
• Primary completion: 2022-06-06
• Completion: 2022-06-06
• First posted: 2018-11-13
• Last updated: 2023-10-25

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study