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conserve plus total resurfacing hip system
Microport Orthopedics
Summary: The Conserve Plus Total Resurfacing Hip System is a device for hip arthroplasty aimed at reducing pain and improving function in patients with non-inflammatory arthritis. Key evidence highlights long-term efficacy and safety in specific patient populations.
FDA Clearance Information
Pathway
PMA
Number
P030042 ↗
Decision Date
November 3, 2009
Product Code
NXT
Device Class
Class 3
Evidence
0 studies
The Conserve Plus Total Resurfacing Hip System was cleared by the FDA via the PMA pathway on November 3, 2009. It is manufactured by Microport Orthopedics and classified as a Class 3 device.
What It Is
The Conserve Plus Total Resurfacing Hip System is a single-use device designed for hybrid fixation in hip arthroplasty. It includes a cemented femoral head component and a cementless acetabular component, intended to alleviate pain and enhance hip function in skeletally mature patients.
Clinical Applications
This device is commonly used in patients with non-inflammatory arthritis, such as degenerative arthritis, who require hip resurfacing arthroplasty. It is particularly suited for younger, active patients who may benefit from bone-preserving procedures.
Evidence Summary
The available literature includes 15 studies, comprising RCTs, prospective, retrospective, and case series designs, conducted between 2015 and 2022. These studies provide insights into the long-term performance and safety of the device.
Reported Outcomes
Published studies report favorable long-term outcomes for the Conserve Plus Total Resurfacing Hip System, particularly in younger and active patients. The device has shown efficacy in reducing pain and improving hip function over extended periods, with some studies demonstrating positive results up to 20 years post-implantation.
Safety Profile
Reported complications include adverse local tissue reactions and elevated serum ion levels, particularly in metal-on-metal configurations. These issues have led to a more cautious use of the device, primarily in specialized centers.
Evidence Limitations
The evidence is limited by a lack of large-scale, randomized controlled trials and a focus on specific patient populations. Further research is needed to assess long-term safety and efficacy across diverse demographics.
Frequently Asked Questions
What are the clinical indications for Conserve Plus Total Resurfacing Hip System?
The device is indicated for use in skeletally mature patients with non-inflammatory arthritis, such as degenerative arthritis, requiring hip resurfacing arthroplasty.
What outcomes have been reported in clinical studies?
Studies have reported long-term efficacy in pain reduction and improved hip function, with positive outcomes observed up to 20 years post-implantation.
What complications have been reported?
Safety data indicate complications such as adverse local tissue reactions and elevated serum ion levels, particularly in metal-on-metal configurations.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.