OsteopetrosisNCT06521580
Outcomes of Patients With Osteopetrosis Weight-bearing Bone Fractures
A study testing Open reduction and internal fixation in people with Osteopetrosis, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteopetrosis
- What is being tested?
- Open reduction and internal fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with adult osteopetrosis above 18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr Al Ainy-Cairo University- Faculty of Medicine
Cairo, Manial, 11956
About this study
Official title: What Are the Clinical and Radiological Outcomes of Open Reduction and Internal Fixation in Adult Patients With Osteopetrosis Weight-bearing Bone Fractures
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.
Read the 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.
- Conditions
- Osteopetrosis
- Being tested
- Open reduction and internal fixation
- Medical subject headings
- Osteopetrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal fixationProcedure or surgery
Open reduction and internal fixation of those with osteopetrosis and weight bearing fractures
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Open reduction and internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone union
We follow up the patients for bone union through radiological examination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopetrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Omar Sabry, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521580
- Sponsor's protocol ID
- N-375-2023
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: unless upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Clinical and Radiological Outcomes of Open Reduction and Internal Fixation in Adult Patients With Osteopetrosis Weight-bearing Bone Fractures
- ClinicalTrials.gov ID
- NCT06521580
- Acronym / sponsor ID
- N-375-2023
- Conditions
- Osteopetrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open reduction and internal fixation | Experimental | Procedure: Open reduction and internal fixationOpen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with adult osteopetrosis above 18 years of age
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open reduction and internal fixationOpen reduction and internal fixation of those with osteopetrosis and weight bearing fractures | Procedure or surgery | open reduction and internal fixation |
Primary outcome
Bone union
Time frame: 6 months
We follow up the patients for bone union through radiological examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No. unless upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction and internal fixation in people with Osteopetrosis, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone union (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.