Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System Clinical Trial
Official title:
A Prospective, Multicenter Study to Evaluate the Conformis Hip System
| NCT number | NCT03738462 |
| Other study ID # | 18-001 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 26, 2018 |
| Est. completion date | June 6, 2022 |
| Verified date | October 2023 |
| Source | Restor3D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 49 |
| Est. completion date | June 6, 2022 |
| Est. primary completion date | June 6, 2022 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Personalized Orthopedic Research Institute | Boynton Beach | Florida |
| United States | Orthopaedic Institute of Henderson | Henderson | Nevada |
| United States | Scott Orthopedic Center | Huntington | West Virginia |
| United States | Tennessee Orthopaedic Alliance | Nashville | Tennessee |
| United States | Denver Hip and Knee | Parker | Colorado |
| United States | The Orthopedic Specialty Center of Northern California | Roseville | California |
| Lead Sponsor | Collaborator |
|---|---|
| Restor3D |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Revision rates post-implantation | 10 Years | ||
| Secondary | The Hip Injury and Osteoarthritis Outcome Score (HOOS) | Score 0-100 for each of 5 subscales (symptoms, stiffness, pain, function, and quality of life) | 10 Years | |
| Secondary | Incidence of major procedure-related and device-related complications including infection rate | 10 Years | ||
| Secondary | Post-operative leg length and implant placement in comparison to preoperative condition | Peri-operative | ||
| Secondary | Utilization of fluoroscopy during implantation (number of times utilized; amount of times utilized) | Peri-operative | ||
| Secondary | Length of procedure | Peri-operative | ||
| Secondary | Length of hospital stay | Peri-operative | ||
| Secondary | Blood management (transfusions) | Peri-operative |