A Study to Evaluate the Conformis Hip System

NCT03738462 | Terminated FDA Device

• 1 other identifier: 18-001
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Revision rates post-implantation

  10 Years

• The Hip Injury and Osteoarthritis Outcome Score (HOOS)

  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

Interventions

Conformis Hip System DEVICE

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).

Also known as: Cordera Hip System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• Restor3D: lead

Study Sites (6)

The Orthopedic Specialty Center of Northern California

Roseville, California, 95678, United States

Location

Denver Hip and Knee

Parker, Colorado, 80134, United States

Location

Personalized Orthopedic Research Institute

Boynton Beach, Florida, 33437, United States

Location

Orthopaedic Institute of Henderson

Henderson, Nevada, 89052, United States

Location

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37203, United States

Location

Scott Orthopedic Center

Huntington, West Virginia, 25702, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 13, 2018
• Study Start: November 26, 2018
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)