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A Study to Evaluate the Conformis Hip System

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ClinicalTrials.gov Identifier: NCT03738462
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System Device: Conformis Hip System

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Study to Evaluate the Conformis Hip System
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : October 31, 2030
Groups and Cohorts
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Intervention Details:
  • 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).
    Other Name: Cordera Hip System

Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Revision rates post-implantation [ Time Frame: 10 Years ]
  2. The Hip Injury and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 10 Years ]
    Score 0-100 for each of 5 subscales (symptoms, stiffness, pain, function, and quality of life)

  3. Incidence of major procedure-related and device-related complications including infection rate [ Time Frame: 10 Years ]
  4. Post-operative leg length and implant placement in comparison to preoperative condition [ Time Frame: Peri-operative ]
  5. Utilization of fluoroscopy during implantation (number of times utilized; amount of times utilized) [ Time Frame: Peri-operative ]
  6. Length of procedure [ Time Frame: Peri-operative ]
  7. Length of hospital stay [ Time Frame: Peri-operative ]
  8. Blood management (transfusions) [ Time Frame: Peri-operative ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738462


Contacts
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Contact: Marc Quartulli 7813459191 marc.quartulli@conformis.com

Locations
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United States, California
The Orthopedic Specialty Center of Northern California Recruiting
Roseville, California, United States, 95678
Contact: Kristina Surber       kristina@tosnorcal.com   
Principal Investigator: Robert Jamieson         
United States, Colorado
Denver Hip and Knee Recruiting
Parker, Colorado, United States, 80134
Contact: Amy Gridley       acrafferty@msn.com   
Principal Investigator: Derek Johnson, MD         
United States, Florida
Personalized Orthopedic Research Institute Recruiting
Boynton Beach, Florida, United States, 33437
Contact: Brenda Sapir       brendas@popb.md   
Principal Investigator: Gregory Martin, MD         
United States, Nevada
Orthopaedic Institute of Henderson Recruiting
Henderson, Nevada, United States, 89052
Contact: Lisa DeBrouwer       lisa@oihnv.com   
Principal Investigator: Robert Tait, MD         
United States, Tennessee
Tennessee Orthopaedic Alliance Recruiting
Nashville, Tennessee, United States, 37203
Contact: Rena Rolfe       renacrolfe@gmail.com   
Principal Investigator: William Kurtz, MD         
United States, West Virginia
Scott Orthopedic Center Recruiting
Huntington, West Virginia, United States, 25702
Contact: Hannah Maier       hannah@scottorthopedic.com   
Principal Investigator: Vivek Neginhal, MD         
Sponsors and Collaborators
ConforMIS, Inc.
More Information
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Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT03738462    
Other Study ID Numbers: 18-001
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes