Clinical trial NCT03738462: A Study to Evaluate the Conformis Hip System
Official title: A Prospective, Multicenter Study to Evaluate the Conformis Hip System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2018-11-13
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


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
* 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

Primary outcomes:
measure: Harris Hip Score
timeFrame: 2 Years
Secondary outcomes:
measure: Revision rates post-implantation
timeFrame: 10 Years
measure: The Hip Injury and Osteoarthritis Outcome Score (HOOS)
timeFrame: 10 Years
measure: Incidence of major procedure-related and device-related complications including infection rate
timeFrame: 10 Years
measure: Post-operative leg length and implant placement in comparison to preoperative condition
timeFrame: Peri-operative
measure: Utilization of fluoroscopy during implantation (number of times utilized; amount of times utilized)
timeFrame: Peri-operative
measure: Length of procedure
timeFrame: Peri-operative
measure: Length of hospital stay
timeFrame: Peri-operative
measure: Blood management (transfusions)
timeFrame: Peri-operative
Other outcomes:
Locations:
city: Roseville
country: United States
facility: The Orthopedic Specialty Center of Northern California
state: California
city: Parker
country: United States
facility: Denver Hip and Knee
state: Colorado
city: Boynton Beach
country: United States
facility: Personalized Orthopedic Research Institute
state: Florida
city: Henderson
country: United States
facility: Orthopaedic Institute of Henderson
state: Nevada
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
city: Huntington
country: United States
facility: Scott Orthopedic Center
state: West Virginia
Study officials:
References: