Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System
Conditions
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.
Interventions
DEVICEConformis 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).
Sponsors
Restor3D
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 | — |
| Revision rates post-implantation | 10 Years | — |
| Length of procedure | Peri-operative | — |
| Length of hospital stay | Peri-operative | — |
| Blood management (transfusions) | Peri-operative | — |
| Utilization of fluoroscopy during implantation (number of times utilized; amount of times utilized) | Peri-operative | — |
Countries
United States
Outcome results
None listed