Outcomes of Patients With Osteopetrosis Weight-bearing Bone Fractures

NCT06521580 | Completed

• 1 other identifier: N-375-2023
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopetrosis

Outcome Measures

Primary Outcomes (1)

• Bone union

  We follow up the patients for bone union through radiological examination

  6 months

Study Arms (1)

open reduction and internal fixation

EXPERIMENTAL

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.

Procedure: Open reduction and internal fixation

Interventions

Open reduction and internal fixation PROCEDURE

Open reduction and internal fixation of those with osteopetrosis and weight bearing fractures

open reduction and internal fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with adult osteopetrosis above 18 years of age

You may not qualify if:

• Non-weight-bearing fractures Non-osteopetrosis patients Pediatric patients Previous fracture surgery Concurrent bone conditions Inability to follow up Infection at fracture site Severe comorbidities Pregnancy Non-surgical treatment preference

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al Ainy-Cairo University- Faculty of Medicine

Cairo, Manial, 11956, Egypt

Location

MeSH Terms

Conditions

Osteopetrosis

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Osteosclerosis; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: June 24, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)