Osteopenia, OsteoporosisosteoporosisNCT06812195
Periprosthetic Plate Over Humeral Nail
A study testing Plate and nail in people with Osteopenia, Osteoporosis, run by Assiut University.
Trial summary
use of plate over humeral nail in deformity correction of femur in adult osteoporotic bone Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- Plate and nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Osteoporotic bone with femoral deformity.
- Osteogenesis imperfecta. --Vitamin D deficiency ricket
Who cannot join
- Uncooperative patient.
- -- Skeletally immature
- Not receiving medical treatment.
- Patient with history of allergy to drugs used in the study.
- Neuromuscular pathology, previous trauma, or surgery to the leg
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Plate Over Humeral Nail in Deformity Correction of Femur in Adult Osteoporotic Bone
use of plate over humeral nail in deformity correction of femur in adult osteoporotic bone
Read the detailed description
small IM interlocking nail, such as humeral nail, could be used in femoral fixation in normal adolescent patients due to the advantages of the entry point lateral to tip of greater trochanter resulting in avoiding iatrogenic vascular injury and being the IM locking device with smaller diameter and shorter length than conventional femoral nail which was appropriate for small-sized adolescent femoral anatom
- Conditions
- Osteopenia, Osteoporosis
- Being tested
- Plate and nail
- Keywords
- deformity, osteoporosis
- Medical subject headings
- Bone Diseases, Metabolic, Congenital Abnormalities, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plate and nailDevice
spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of nail according to preoperative plan. After that, plate is applied to lateral border to the femoral shaft
| Study group | Role | What they receive |
|---|---|---|
| plate over humeral nail | Experimental | spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of nail according to preoperative plan. After that, plate is applied to lateral border to the feoral shaft Receives: Device: Plate and nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metal failure
Number of cases with bending or protrusion
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteopenia, OsteoporosisStudies 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
- Under spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of humeral nail according to preoperative plan. After that, plate is applied to lateral border to the feoral shaft. Weight bearing is allowed after confirmation of union after 6 weeks. Regular visits every 3 months.
- Masking
- None (open label)
- Enrolment
- 3 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
- Hesham M Elbaseet, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812195
- Sponsor's protocol ID
- PPON
- Other IDs
- PPOND
- Acronym
- osteoporosis
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gordon JE, Khanna N, Luhmann SJ, Dobbs MB, Ortman MR, Schoenecker PL. Intramedullary nailing of femoral fractures in children through the lateral aspect of the greater trochanter using a modified rigid humeral intramedullary nail: preliminary results of a new technique in 15 children. J Orthop Trauma. 2004 Aug;18(7):416-22; discussion 423-4. doi: 10.1097/00005131-200408000-00004.
PubMed 15289686
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plate Over Humeral Nail in Deformity Correction of Femur in Adult Osteoporotic Bone
- ClinicalTrials.gov ID
- NCT06812195
- Acronym / sponsor ID
- osteoporosis / PPON
- Conditions
- Osteopenia, Osteoporosis
- Keywords
- deformity, osteoporosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 6 Feb 2025 (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.
use of plate over humeral nail in deformity correction of femur in adult osteoporotic bone
Detailed description
small IM interlocking nail, such as humeral nail, could be used in femoral fixation in normal adolescent patients due to the advantages of the entry point lateral to tip of greater trochanter resulting in avoiding iatrogenic vascular injury and being the IM locking device with smaller diameter and shorter length than conventional femoral nail which was appropriate for small-sized adolescent femoral anatom
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Under spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of humeral nail according to preoperative plan. After that, plate is applied to lateral border to the feoral shaft. Weight bearing is allowed after confirmation of union after 6 weeks. Regular visits every 3 months.
| Arm | Type | Receives |
|---|---|---|
| plate over humeral nail | Experimental | Device: Plate and nailspinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of nail according to preoperative plan. After that, plate is applied to lateral border to the feoral shaft |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Osteoporotic bone with femoral deformity.
- Osteogenesis imperfecta. --Vitamin D deficiency ricket
Key exclusion criteria (5 listed)
- Uncooperative patient.
- -- Skeletally immature
- Not receiving medical treatment.
- Patient with history of allergy to drugs used in the study.
- Neuromuscular pathology, previous trauma, or surgery to the leg
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 |
|---|---|---|
| Plate and nailspinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of nail according to preoperative plan. After that, plate is applied to lateral border to the femoral shaft | Device | plate over humeral nail |
Primary outcome
Metal failure
Time frame: 2 years
Number of cases with bending or protrusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 15289686Gordon JE, Khanna N, Luhmann SJ, Dobbs MB, Ortman MR, Schoenecker PL. Intramedullary nailing of femoral fractures in children through the lateral aspect of the greater trochanter using a modified rigid humeral intramedullary nail: preliminary results of a new technique in 15 children. J Orthop Trauma. 2004 Aug;18(7):416-22; discussion 423-4. doi: 10.1097/00005131-200408000-00004.
- 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.
Hesham M Elbaseet, MD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Plate and nail in people with Osteopenia, Osteoporosis, run by Assiut University.
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 5 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: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hesham m Elbaseet, MD (201007780689 ext. 20, drhesham20@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metal failure (time frame: 2 years). 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 NCT06812195, which also lists 1 linked publication.
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 12 Feb 2025.