Osteogenesis ImperfectaOINCT05878548
Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient
A study testing corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture in people with Osteogenesis Imperfecta, run by Assiut University at 1 site in Egypt.
Trial summary
O.I with NOF fixed by Wagner technique and telescoping nail Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Apr 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- OI
Who cannot join
- Not receiving Bisphosphonate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine Assiut university
Asyut, 71515
Hesham M Elbaseet, MD, +2001007780689, drhesham20@aun.edu.eg
About this study
O.I with NOF fixed by Wagner technique and telescoping nail
Read the detailed description
osteogenesis imperfecta (Sillence Type IV) sustained neck of femur fracture after fall on ground. He had proximal femoral anterolateral bowing on top of inserted rod 4 years ago. He was treated with corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture. One year after operation the patient gained satisfactory functional outcome with union of NOF fracture and correction of femoral deformity. This rare case illustrates the anticipated difficulties in managing neck of femur fracture in osteogenesis imperfect patients. The method of fixation with Wagner technique can achieve stable fixation for solid healing in fragility fractures like this and the least interference with telescoping nail insertion.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture
- Keywords
- Osteogenesis imperfecta, fracture neck of femur, telescoping nail
- Medical subject headings
- Osteogenesis Imperfecta, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fractureProcedure or surgery
corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture
| Study group | Role | What they receive |
|---|---|---|
| fixation with Wagner technique and Telescoping nail | Experimental | corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture Receives: Procedure: corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified McKay's criteria
hip function score the higher the score the better outcome graded into excellent, Good , Fair and Poor
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Aug 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- fixation with Wagner technique
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohamed Elbaseet, Assiut University
- Investigators
- Hesaham M Elbaseet, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878548
- Sponsor's protocol ID
- NOFOI
- Acronym
- OI
- Status last verified
- Jan 2024
- First submitted
- 18 May 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hidalgo Perea S, Green DW. Osteogenesis imperfecta: treatment and surgical management. Curr Opin Pediatr. 2021 Feb 1;33(1):74-78. doi: 10.1097/MOP.0000000000000968.
PubMed 33278111Fralinger DJ, Kraft DB, Rogers KJ, Thacker MM, Kruse RW, Franzone JM. The Fate of the Bent Rod in Children With Osteogenesis Imperfecta. J Pediatr Orthop. 2023 Jul 1;43(6):e465-e470. doi: 10.1097/BPO.0000000000002409. Epub 2023 Apr 6.
PubMed 37026790
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient
- ClinicalTrials.gov ID
- NCT05878548
- Acronym / sponsor ID
- OI / NOFOI
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Osteogenesis imperfecta, fracture neck of femur, telescoping nail
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 26 May 2023 (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.
O.I with NOF fixed by Wagner technique and telescoping nail
Detailed description
osteogenesis imperfecta (Sillence Type IV) sustained neck of femur fracture after fall on ground. He had proximal femoral anterolateral bowing on top of inserted rod 4 years ago. He was treated with corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture. One year after operation the patient gained satisfactory functional outcome with union of NOF fracture and correction of femoral deformity. This rare case illustrates the anticipated difficulties in managing neck of femur fracture in osteogenesis imperfect patients. The method of fixation with Wagner technique can achieve stable fixation for solid healing in fragility fractures like this and the least interference with telescoping nail insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- fixation with Wagner technique
| Arm | Type | Receives |
|---|---|---|
| fixation with Wagner technique and Telescoping nail | Experimental | Procedure: corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracturecorrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- OI
Key exclusion criteria (1 listed)
- Not receiving Bisphosphonate
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 |
|---|---|---|
| corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracturecorrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture | Procedure or surgery | fixation with Wagner technique and Telescoping nail |
Primary outcome
modified McKay's criteria
Time frame: 1 year
hip function score the higher the score the better outcome graded into excellent, Good , Fair and Poor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 33278111Hidalgo Perea S, Green DW. Osteogenesis imperfecta: treatment and surgical management. Curr Opin Pediatr. 2021 Feb 1;33(1):74-78. doi: 10.1097/MOP.0000000000000968.
- Background: PubMed 37026790Fralinger DJ, Kraft DB, Rogers KJ, Thacker MM, Kruse RW, Franzone JM. The Fate of the Bent Rod in Children With Osteogenesis Imperfecta. J Pediatr Orthop. 2023 Jul 1;43(6):e465-e470. doi: 10.1097/BPO.0000000000002409. Epub 2023 Apr 6.
- 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.
Hesaham M Elbaseet, MD 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?
A study testing corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture in people with 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 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: status not confirmed, as of the sponsor's last update on 31 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hesaham M Elbaseet, MD (+2001007780689, drhesham20@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified McKay's criteria (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878548, which also lists 2 linked publications.
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 31 Jan 2024.