A Study to Evaluate the Conformis Hip System

A Prospective, Multicenter Study to Evaluate the Conformis Hip System

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.

Study Overview

• Status: Terminated
• Conditions: Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System
• Intervention / Treatment: Device: Conformis Hip System

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • California
    • Roseville, California, United States, 95678
      • The Orthopedic Specialty Center of Northern California
  • Colorado
    • Parker, Colorado, United States, 80134
      • Denver Hip and Knee
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Personalized Orthopedic Research Institute
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Orthopaedic Institute of Henderson
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Orthopaedic Alliance
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • Scott Orthopedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical condition included in the approved Indications For Use for the Conformis Hip System and the Cordera Hip System

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score	Score 0-100 (successful result = post operative increase in Harris Hip Score of > 20 points + radiographically stable implant + no additional femoral reconstruction; < 70 = poor, 70-79 - fair, 80-89 = good, and 90-100 = excellent)	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision rates post-implantation		10 Years
The Hip Injury and Osteoarthritis Outcome Score (HOOS)	Score 0-100 for each of 5 subscales (symptoms, stiffness, pain, function, and quality of life)	10 Years
Incidence of major procedure-related and device-related complications including infection rate		10 Years
Post-operative leg length and implant placement in comparison to preoperative condition		Peri-operative
Utilization of fluoroscopy during implantation (number of times utilized; amount of times utilized)		Peri-operative
Length of procedure		Peri-operative
Length of hospital stay		Peri-operative
Blood management (transfusions)		Peri-operative

Collaborators and Investigators

• Sponsor: Restor3D

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes