Viewing Study NCT06521580



Ignite Creation Date: 2024-10-26 @ 3:36 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06521580
Status: COMPLETED
Last Update Posted: None
First Post: 2024-07-22

Brief Title: Outcomes of Patients With Osteopetrosis Weight-bearing Bone Fractures
Sponsor: None
Organization: None

Study Overview

Official Title: What Are the Clinical and Radiological Outcomes of Open Reduction and Internal Fixation in Adult Patients With Osteopetrosis Weight-bearing Bone Fractures
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Osteopetrosis is a rare genetic disorder characterized by the abnormal hardening and density of bones leading to increased brittleness and susceptibility to fractures This condition presents significant challenges in fracture management due to the altered bone architecture and compromised healing capacity Open reduction and internal fixation ORIF is a common surgical technique employed to stabilize fractures but its efficacy and outcomes in patients with osteopetrosis are not well-documented This study aims to evaluate the clinical and radiological outcomes of ORIF in adult patients with weight-bearing bone fractures due to osteopetrosis providing insights into the effectiveness and potential complications of this treatment approach
Detailed Description: Osteopetrosis also known as marble bone disease is a rare genetic disorder that leads to the abnormal hardening and densification of bones due to defective osteoclast-mediated bone resorption This imbalance results in bones that are abnormally dense yet fragile and prone to fractures Osteopetrosis is typically categorized into three major types based on severity and inheritance patterns autosomal recessive infantile osteopetrosis autosomal recessive intermediate osteopetrosis and autosomal dominant adult osteopetrosis

In adult patients osteopetrosis often presents with a range of clinical manifestations including bone pain frequent fractures cranial nerve compression and hematological abnormalities due to bone marrow space reduction Weight-bearing bones such as the femur tibia and pelvis are particularly susceptible to fractures due to the mechanical stress they endure These fractures pose significant clinical challenges because the dense bone structure complicates surgical intervention and delays healing

Open reduction and internal fixation ORIF is a common surgical technique used to treat fractures by realigning and stabilizing the broken bones with hardware such as plates screws or rods In the context of osteopetrosis ORIF can be particularly challenging due to the sclerotic nature of the bone which makes drilling and hardware placement difficult and the poor vascularity which can impede healing and increase the risk of complications such as nonunion or infection

Despite these challenges ORIF remains a critical option for managing fractures in osteopetrosis patients Understanding the clinical and radiological outcomes of this intervention can help optimize treatment protocols and improve patient care This case series aims to evaluate the outcomes of ORIF in adult patients with osteopetrosis-induced weight-bearing bone fractures By examining factors such as fracture healing functional recovery and complication rates this study seeks to provide valuable insights into the effectiveness and potential risks associated with ORIF in this unique patient population

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None