Trochanteric FracturesNCT05781815
Treatment Of Unstable Trochanteric Fracture: A Comparative Study Between DHS And DHS With Trochanteric Stabilization Plate
A study testing dynamic hip screw in people with Trochanteric Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
compare the results in treatment of unstable trochanteric fracture by using DHS and DHS with Trochanteric Stabilizing plate as regard shaft medialization.neck shaft angle measurment and shaft migration Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trochanteric Fractures
- What is being tested?
- dynamic hip screw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2023to 8 Aug 2023
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pateints with comminution of medial femoral cortex and loss of continuity of lesser trochanter
Who cannot join
- stable trochanteric fracture subtrochanteric extension reverse oblique trochanteric fracture
Trial locations and contacts
1 site in 1 country.
Shazly sa saleh moussa, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag, Sohag
magdy m amin, professor
About this study
compare the results in treatment of unstable trochanteric fracture by using DHS and DHS with Trochanteric Stabilizing plate as regard shaft medialization.neck shaft angle measurment and shaft migration
- Conditions
- Trochanteric Fractures
- Being tested
- dynamic hip screw
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic hip screwProcedure or surgery
using dynamic hip screw in treatment of trochanteric fracture and dynamic hip screw with trochanteric stabilizing plate
| Study group | Role | What they receive |
|---|---|---|
| DHS | Active comparator | patients with trochanteric fracture treated with DHS Receives: Procedure: dynamic hip screw |
| DHS with Trochanteric stabilizing plate | Active comparator | patients with trochanteric fracture treated with DHS with trochanteric stabilizing plate Receives: Procedure: dynamic hip screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
neck shaft angle measurment .Harris hip score
measurment of neck shaft angle between two groups
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 posted23 Mar 2023
- Study start10 Feb 2023
- Primary completion8 Aug 2023 (estimated)
- Study completion8 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trochanteric FracturesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abdelaleem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781815
- Sponsor's protocol ID
- Soh-Med-23-02-02
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Babhulkar S. Unstable trochanteric fractures: Issues and avoiding pitfalls. Injury. 2017 Apr;48(4):803-818. doi: 10.1016/j.injury.2017.02.022. Epub 2017 Feb 27.
PubMed 28284469Ahrengart L, Tornkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlstrom P, Honkonen S, Lindgren U. A randomized study of the compression hip screw and Gamma nail in 426 fractures. Clin Orthop Relat Res. 2002 Aug;(401):209-22. doi: 10.1097/00003086-200208000-00024.
PubMed 12151898SCHUMPELICK W, JANTZEN PM. A new principle in the operative treatment of trochanteric fractures of the femur. J Bone Joint Surg Am. 1955 Jul;37-A(4):693-8. No abstract available.
PubMed 13242603Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
PubMed 5783851
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Of Unstable Trochanteric Fracture: A Comparative Study Between DHS And DHS With Trochanteric Stabilization Plate
- ClinicalTrials.gov ID
- NCT05781815
- Acronym / sponsor ID
- Soh-Med-23-02-02
- Conditions
- Trochanteric Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 8 Aug 2023 (estimated)
- Study completion
- 8 Aug 2023 (estimated)
- First posted
- 23 Mar 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.
compare the results in treatment of unstable trochanteric fracture by using DHS and DHS with Trochanteric Stabilizing plate as regard shaft medialization.neck shaft angle measurment and shaft migration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHS | Active comparator | Procedure: dynamic hip screwpatients with trochanteric fracture treated with DHS |
| DHS with Trochanteric stabilizing plate | Active comparator | Procedure: dynamic hip screwpatients with trochanteric fracture treated with DHS with trochanteric stabilizing plate |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pateints with comminution of medial femoral cortex and loss of continuity of lesser trochanter
Key exclusion criteria (1 listed)
- stable trochanteric fracture subtrochanteric extension reverse oblique trochanteric fracture
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 |
|---|---|---|
| dynamic hip screwusing dynamic hip screw in treatment of trochanteric fracture and dynamic hip screw with trochanteric stabilizing plate | Procedure or surgery | DHS, DHS with Trochanteric stabilizing plate |
Primary outcome
neck shaft angle measurment .Harris hip score
Time frame: 6 months
measurment of neck shaft angle between two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 28284469Babhulkar S. Unstable trochanteric fractures: Issues and avoiding pitfalls. Injury. 2017 Apr;48(4):803-818. doi: 10.1016/j.injury.2017.02.022. Epub 2017 Feb 27.
- Background: PubMed 12151898Ahrengart L, Tornkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlstrom P, Honkonen S, Lindgren U. A randomized study of the compression hip screw and Gamma nail in 426 fractures. Clin Orthop Relat Res. 2002 Aug;(401):209-22. doi: 10.1097/00003086-200208000-00024.
- Background: PubMed 13242603SCHUMPELICK W, JANTZEN PM. A new principle in the operative treatment of trochanteric fractures of the femur. J Bone Joint Surg Am. 1955 Jul;37-A(4):693-8. No abstract available.
- Background: PubMed 5783851Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
- Individual participant dataSharing planned: Yes
Related trials for Trochanteric Fractures
Not yet recruiting
Trochanteric Bursa Repair and Lateral Hip Pain After Hemiarthroplasty for Femoral Neck Fracture
Femoral Neck Fracture
Active, not recruiting
Insignia™ Hip Stem Outcomes Study
Hip Osteoarthritis, Avascular Necrosis
Recruiting
Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures
Hip Injuries and Disorders, Hip Fractures
Enrolling by invitation
G7 Freedom Constrained Vivacit-E Liners
Osteoarthritis, Hip, Rheumatoid Arthritis
Active, not recruitingObservational study
G7 BiSpherical Acetabular Shell PMCF Study
Rheumatoid Arthritis, Osteoarthritis
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.
Shazly sa saleh moussa, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic hip screw in people with Trochanteric Fractures, run by Sohag 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 23 Mar 2023. 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 Ahmed Mo MOHAMED ABD EL ALEEM, resident (01114673751, ahmedabdelalem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neck shaft angle measurment .Harris hip score (time frame: 6 months). 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 NCT05781815, which also lists 4 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 23 Mar 2023.