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Methods for detecting adverse local tissue reaction (ALTR) necrosis

A local tissue, poor technology, used in biochemical equipment and methods, measuring devices, pharmaceutical formulations, etc., can solve problems such as infection, difficult to explain scanning, low incidence, etc.

Inactive Publication Date: 2018-06-08
CD DIAGNOSTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Despite the availability of metal reduction software, these scans are often difficult to interpret
Despite the merits of each of these tests, no single diagnostic test is currently available to describe the critical problem requiring urgent surgical intervention, tissue necrosis.
Furthermore, despite its good track record, MOM implant complications have a relatively low incidence and include infection and ALTR
Tissue damage in severe ALTR can be extensive and difficult to correct

Method used

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  • Methods for detecting adverse local tissue reaction (ALTR) necrosis
  • Methods for detecting adverse local tissue reaction (ALTR) necrosis
  • Methods for detecting adverse local tissue reaction (ALTR) necrosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0324] Example 1: Confirmatory necrosis analysis to determine the need for revision surgery in MOM total hip arthroplasty

[0325] A study was designed to develop a biomarker assay for use as a diagnostic tool for ALTR in subjects with total hip replacement (THR) with MOM.

[0326] To identify biomarkers of ALTR, the composition of samples from ALTR patients needs to be compared with samples from patients of different disease categories. Molecules (typically proteins) present in ALTR patients but absent in other disease groups or normal individuals are potential biomarkers of ALTR. A critical aspect of a biomarker discovery program is the acquisition and testing of well-characterized patient samples from multiple disease categories.

[0327] This study is a multicenter prospective cohort study. To maximize the chances of successful identification of serum biomarkers, all samples were analyzed using a multi-analyte assay biomarker test. The primary endpoint of the study in...

Embodiment 2

[0329] Example 2: Target Biomarkers

[0330] Such biomarker proteins were selected for analysis if their molecular mechanisms involved in the observed histopathology of ALTR were described or suspected. Specifically, macrophages, lymphocytes, T cell-mediated immunity, delayed-type hypersensitivity, innate immunity, necrosis, apoptosis, cell proliferation, osteolysis, wound healing, bone remodeling, and oxidative stress were selected. Biomarkers. Biomarkers of general inflammation and PJI were also included. In total, 8 multiplex Luminex assays were used to analyze 82 different biomarkers. Additionally, 17 biomarkers were analyzed using single ELISA and enzyme assays (Figure 1).

Embodiment 3

[0331] Example 3: Preliminary screening of biomarkers

[0332] With a large number of target biomarkers (99), the process of identifying ALTR biomarkers begins with assembling a relatively small number of synovial fluid samples to be analyzed. All assays were performed according to the manufacturer's recommendations with minor modifications. In addition to MOM samples, pooled synovial fluid samples from patients with PJI, OA, and sterile joints were used as controls ( figure 2 ).

[0333] Synovial fluid was prepared from patients with aseptic joints (3 sterile samples pooled together), osteoarthritis (OA) (5 OA samples pooled together), and PJI (4 PJI samples pooled together) at the initial screening Samples were pooled and 5 individual MOM samples were analyzed in the assay for 99 human biomarkers. As used herein, sterile samples were taken from subjects with low probability of ALTR or PJI; OA samples were taken from OA subjects who did not undergo joint replacement sur...

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Abstract

This invention relates to field of screening and diagnosing adverse local tissue reaction (ALTR) in a subject who has received a joint replacement by measuring the level of a nucleic acid or protein biomarker that are elevated in patients suffering from ALTR, even those with no symptoms. The early diagnosis of the ALTR can lead to its treatment and thus, the prevention of implant failure caused bythe ALTR. The elevated proteins and genes are also the basis for treatment for ALTR and provide targets for drug development and basic research.

Description

[0001] Cross References to Related Applications [0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application 62 / 200,885, filed August 4, 2015, the entire contents of which are incorporated herein by reference. Background of the invention [0003] Adverse local tissue reactions (ALTR) can occur in patients with implants such as total hip arthroplasty and hip resurfacing. Over time, metal particles around some implants can cause damage to the bone and / or soft tissue around the implant and joint, leading to ALTR. ALTR can occur in patients with metal-on-polyethylene (MOP) as well as in patients with metal-on-metal (MOM) prostheses, although MOM prostheses generate significantly less wear debris than MOP prostheses. These particulate debris, produced for example by wear at joints, erosion at conical joints, and wear of loose components, produced soluble metal ions that were measurable in blood, despite reduced wear rates. The MOM hip re-enter...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K49/00A61K49/22A61K49/04
CPCG01N2800/52G01N2800/7095C12Q1/6883C12Q2600/106C12Q2600/158G01N33/6893G01N2800/60
Inventor C·戴尔曼吉安K·卡多斯J·W·斯特夫T·若阿金T·K·费林
Owner CD DIAGNOSTICS
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