A Study to Evaluate the Conformis Hip System
- Conditions
- Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System
- Registration Number
- NCT03738462
- Lead Sponsor
- Restor3D
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 49
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Harris Hip Score 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
Name Time Method 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 Score 0-100 for each of 5 subscales (symptoms, stiffness, pain, function, and quality of life)
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
Trial Locations
- Locations (6)
The Orthopedic Specialty Center of Northern California
🇺🇸Roseville, California, United States
Denver Hip and Knee
🇺🇸Parker, Colorado, United States
Orthopaedic Institute of Henderson
🇺🇸Henderson, Nevada, United States
Personalized Orthopedic Research Institute
🇺🇸Boynton Beach, Florida, United States
Scott Orthopedic Center
🇺🇸Huntington, West Virginia, United States
Tennessee Orthopaedic Alliance
🇺🇸Nashville, Tennessee, United States