Osteogenesis ImperfectaNCT04694144
Results of Telescoping Nail In OI; a Case Series
An observational study of Osteogenesis Imperfecta, run by Assiut University at 1 site in Egypt.
Trial summary
Assess the postoperative functional outcomes after surgical correction of skeletal deformities of lower limbs in osteogenesis imperfecta patients as regard ambulation status, postoperative complications and reoperation rate. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- telescoping intramedullary nail
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to Mar 2024
- Phase
- Observational
- 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 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: all Osteogenesis imperfecta patients admitted at assiut university pediatric and main hospitals with age range 3- 11 years old presented with lower limb skeletal deformities with or without fracture will be included in our study
Who may be able to join
- Age from 3-11 years
- Severe lower limb deformity presented with or without fracture
Who cannot join
- Nondisplaced/incomplete fractures in minimally deformed bones
- Deformity angulation less than 20 degree
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital AUH
Asyut, 71526
Assiut University Hospital AUH, 0020882333327, med@aun.edu.eg
Assiut University Hospital AUH
About this study
Official title: Results of Telescoping Nail in. OI; A Case Series
Assess the postoperative functional outcomes after surgical correction of skeletal deformities of lower limbs in osteogenesis imperfecta patients as regard ambulation status, postoperative complications and reoperation rate.
Read the detailed description
Osteogenesis imperfecta (OI) is a rare heterogeneous group of inherited disorders characterized by brittle bones, frequent fractures, and skeletal deformities that affect an individual's ability to walk. Based on Sillence classification, there are four types of OI; Type I (mild, non-deforming), Type II (perinatal lethal), Type III (severely deforming), and Type IV (moderately deforming). Recently 3 types added type V, VI and type VII.
Deformities of the long bones are common in patients with osteogenesis imperfecta particularly in the lower limbs Where they are also more severe. Multiple fractures can occur and the ability to walk may be compromised.
The goal of orthopaedic surgery implies the correction of long bone bowing, rotational malalignment, angular deformity and prevention or reduction of the fracture incidence .Surgical intervention in the form of multiple osteotomies, realignment and fixation by intramedullary rods can correct deformity of the long bones and provides internal support enhancing the potential for standing and assisted or independent walking Sofield and Millar, Page and Mead popularized the operation of multiple osteotomies and fixation by intramedullary rods. In 1963 the baily dubow nail was first introduced The telescopic rodding and nailing have been developed in order to obtain a long lasting osteosynthesis in a growing long bone, thus, reducing the need of replacement. The evolution of telescoping rods for the treatment of fractures and deformity in children with diminished bone Quality has resulted in an approved and commercially available new single entry telescopic rod system, the Fassier Duval Telescopic IM System (FD-rod).
In recent publications a high reoperation rate for proximal rod migration and a complication rate up to 40% because of rod migration, limited telescoping and joint protrusion was found.
We hope that our study will advance the proper surgical intervention for children with osteogenesis imperfecta for better functional outcomes
- Conditions
- Osteogenesis Imperfecta
- Being tested
- telescoping intramedullary nail
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telescoping intramedullary nailDevice
Also called growing nail
All osteogenesis imperfecta patients with lower limb skeletal deformities corrected with multiple corrective osteotomies and insertion of two parts male and female segments of intramedullary telescoping nail
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulation status
the mobility status of each child will be allocated to one of the scores of the Gillette Functional Assessment Questionnaire Ambulation Scale and Hoffer and Bollock score
Measured: All patients will be assessed clinically and radiologically for deformity 6 months after surgery.
Rod Complications
Radiographic evidence of rod problems including migration, bending, breakage, disengagement, jamming (failure of expansion/telescoping)
Measured: All patients will be assessed radiologically for evidence of rod complications within the first two years after surgery.
Secondary outcomes (3)
Bone consolidation
patients will be assessed for the average time in weeks of consolidation at the osteotomy site(s)
Measured: All patients will be assessed clinically and radiologically one month after surgery.
Timing of weight-bearing
The average time in weeks until full weight bearing
Measured: All patients will be assessed clinically within the first three months after surgery.
Refracture
The occurrence of a second fracture at the same long bone with the rod in place or in association with any rod complication
Measured: All patients will be assessed clinically and radiologically for refracture within the first two years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Dec 2020
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nariman Abol Oyoun, MD, Assiut University
- Investigators
- Nariman Abol Oyoun, MD, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694144
- Sponsor's protocol ID
- TIN in osteogenesis
- Status last verified
- Aug 2021
- First submitted
- 13 Dec 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Telescoping Nail in. OI; A Case Series
- ClinicalTrials.gov ID
- NCT04694144
- Acronym / sponsor ID
- TIN in osteogenesis
- Conditions
- Osteogenesis Imperfecta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 5 Jan 2021 (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.
Assess the postoperative functional outcomes after surgical correction of skeletal deformities of lower limbs in osteogenesis imperfecta patients as regard ambulation status, postoperative complications and reoperation rate.
Detailed description
Osteogenesis imperfecta (OI) is a rare heterogeneous group of inherited disorders characterized by brittle bones, frequent fractures, and skeletal deformities that affect an individual's ability to walk. Based on Sillence classification, there are four types of OI; Type I (mild, non-deforming), Type II (perinatal lethal), Type III (severely deforming), and Type IV (moderately deforming). Recently 3 types added type V, VI and type VII.
Deformities of the long bones are common in patients with osteogenesis imperfecta particularly in the lower limbs Where they are also more severe. Multiple fractures can occur and the ability to walk may be compromised.
The goal of orthopaedic surgery implies the correction of long bone bowing, rotational malalignment, angular deformity and prevention or reduction of the fracture incidence .Surgical intervention in the form of multiple osteotomies, realignment and fixation by intramedullary rods can correct deformity of the long bones and provides internal support enhancing the potential for standing and assisted or independent walking Sofield and Millar, Page and Mead popularized the operation of multiple osteotomies and fixation by intramedullary rods. In 1963 the baily dubow nail was first introduced The telescopic rodding and nailing have been developed in order to obtain a long lasting osteosynthesis in a growing long bone, thus, reducing the need of replacement. The evolution of telescoping rods for the treatment of fractures and deformity in children with diminished bone Quality has resulted in an approved and commercially available new single entry telescopic rod system, the Fassier Duval Telescopic IM System (FD-rod).
In recent publications a high reoperation rate for proximal rod migration and a complication rate up to 40% because of rod migration, limited telescoping and joint protrusion was found.
We hope that our study will advance the proper surgical intervention for children with osteogenesis imperfecta for better functional outcomes
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all Osteogenesis imperfecta patients admitted at assiut university pediatric and main hospitals with age range 3- 11 years old presented with lower limb skeletal deformities with or without fracture will be included in our study
Key inclusion criteria (2 listed)
- Age from 3-11 years
- Severe lower limb deformity presented with or without fracture
Key exclusion criteria (2 listed)
- Nondisplaced/incomplete fractures in minimally deformed bones
- Deformity angulation less than 20 degree
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 |
|---|---|---|
| telescoping intramedullary nailAlso: growing nailAll osteogenesis imperfecta patients with lower limb skeletal deformities corrected with multiple corrective osteotomies and insertion of two parts male and female segments of intramedullary telescoping nail | Device | – |
Primary outcome
Ambulation status
Time frame: All patients will be assessed clinically and radiologically for deformity 6 months after surgery.
the mobility status of each child will be allocated to one of the scores of the Gillette Functional Assessment Questionnaire Ambulation Scale and Hoffer and Bollock score
Rod Complications
Time frame: All patients will be assessed radiologically for evidence of rod complications within the first two years after surgery.
Radiographic evidence of rod problems including migration, bending, breakage, disengagement, jamming (failure of expansion/telescoping)
3 secondary outcomes
Bone consolidation
Time frame: All patients will be assessed clinically and radiologically one month after surgery.
Timing of weight-bearing
Time frame: All patients will be assessed clinically within the first three months after surgery.
Refracture
Time frame: All patients will be assessed clinically and radiologically for refracture within the first two years after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Nariman Abol Oyoun, MD, Lecturer principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteogenesis Imperfecta, run by Assiut University 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed abdel zaher, MSc (01021380107, mohamedabdelzaher999@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulation status (time frame: All patients will be assessed clinically and radiologically for deformity 6 months after surgery.). The study lists 2 primary outcomes in all. 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 2 Sep 2021.