A Prospective, Multicenter Study to Evaluate the Conformis Hip System

Restor3D6 sites in 1 country49 target enrollmentNovember 26, 2018

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System
Sponsor: Restor3D
Enrollment: 49
Locations: 6
Primary Endpoint: Harris Hip Score
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 26, 2018

End Date

June 6, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Restor3D

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Harris Hip Score

Time Frame: 2 Years

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)

Secondary Outcomes

Length of procedure(Peri-operative)
Length of hospital stay(Peri-operative)
Incidence of major procedure-related and device-related complications including infection rate(10 Years)
The Hip Injury and Osteoarthritis Outcome Score (HOOS)(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)
Revision rates post-implantation(10 Years)
Blood management (transfusions)(Peri-operative)