Orthopedic DisorderNCT05603858
End Button Tenodesis in Failed Developmental Dysplasia of the Hip Surgery
An observational study of Orthopedic Disorder, run by Al-Azhar University.
Trial summary
Adequate growth and development of the hip depends on two main factors: concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage. Any alteration in these two conditions leads to a hip dysplasia \& dislocation Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Tenodesis by end button
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2022to 29 Nov 2023
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: The patients will be examined for: Length of both lower limbs in relation to each other. Length of both lower limbs according to patient age. Presence of hump related to the outer surface of the hip Presence of pain, abnormal gait, Trendlenburg test Radiographic evaluation (antero posterior and frog pelvis views) An addition to the steps of the open reduction, the following were done: 1. Trans articular suturing 2. End button tenodesis
Who may be able to join
- Patient with Developmental dysplasia of the hip (DDH) with :
- Age: up to 9 years old.
- Recurrent DDH .
- Failed open reduction through medial approach in the management of DDH.
- Traumatic hip dislocation .
Who cannot join
- • Paralytic hip dislocation .
- Post septic hip dislocation.
- Refusal to participate in this study.
Trial locations and contacts
No sites are listed yet.
ahmed khashaba, MD contact
About this study
Official title: The Role of End Button Tenodesis in the Management of Failed Developmental Dysplasia of the Hip Surgery
Adequate growth and development of the hip depends on two main factors: concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage. Any alteration in these two conditions leads to a hip dysplasia \& dislocation
- Conditions
- Orthopedic Disorder
- Being tested
- Tenodesis by end button
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenodesis by end buttonProcedure or surgery
open reduction of the dislocated hip and stabilization by end button
| Study group | Role | What they receive |
|---|---|---|
| Tenodesis by end button | open reduction of the dislocated hip and stabilization by end button Receives: Procedure: Tenodesis by end button |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Harris Hip Score
score for function of the hip
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 posted3 Nov 2022
- Study start29 Nov 2022 (estimated)
- Primary completion29 Nov 2023 (estimated)
- Study completion29 Nov 2023 (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 Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Obeid Abd Allah, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603858
- Sponsor's protocol ID
- EBT
- Status last verified
- Oct 2022
- First submitted
- 29 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang S, Doudoulakis KJ, Khurwal A, Sarraf KM. Developmental dysplasia of the hip. Br J Hosp Med (Lond). 2020 Jul 2;81(7):1-8. doi: 10.12968/hmed.2020.0223. Epub 2020 Jul 6.
PubMed 32730146Schaeffer EK, Study Group I, Mulpuri K. Developmental dysplasia of the hip: addressing evidence gaps with a multicentre prospective international study. Med J Aust. 2018 May 7;208(8):359-364. doi: 10.5694/mja18.00154.
PubMed 29716513
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of End Button Tenodesis in the Management of Failed Developmental Dysplasia of the Hip Surgery
- ClinicalTrials.gov ID
- NCT05603858
- Acronym / sponsor ID
- EBT
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 29 Nov 2022 (estimated)
- Primary completion
- 29 Nov 2023 (estimated)
- Study completion
- 29 Nov 2023 (estimated)
- First posted
- 3 Nov 2022 (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.
Adequate growth and development of the hip depends on two main factors: concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage. Any alteration in these two conditions leads to a hip dysplasia \& dislocation
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tenodesis by end button | – | Procedure: Tenodesis by end buttonopen reduction of the dislocated hip and stabilization by end button |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The patients will be examined for: Length of both lower limbs in relation to each other. Length of both lower limbs according to patient age. Presence of hump related to the outer surface of the hip Presence of pain, abnormal gait, Trendlenburg test Radiographic evaluation (antero posterior and frog pelvis views) An addition to the steps of the open reduction, the following were done: 1. Trans articular suturing 2. End button tenodesis
Key inclusion criteria (5 listed)
- Patient with Developmental dysplasia of the hip (DDH) with :
- Age: up to 9 years old.
- Recurrent DDH .
- Failed open reduction through medial approach in the management of DDH.
- Traumatic hip dislocation .
Key exclusion criteria (3 listed)
- • Paralytic hip dislocation .
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 |
|---|---|---|
| Tenodesis by end buttonopen reduction of the dislocated hip and stabilization by end button | Procedure or surgery | Tenodesis by end button |
Primary outcome
modified Harris Hip Score
Time frame: 6 months
score for function of the hip
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 32730146Zhang S, Doudoulakis KJ, Khurwal A, Sarraf KM. Developmental dysplasia of the hip. Br J Hosp Med (Lond). 2020 Jul 2;81(7):1-8. doi: 10.12968/hmed.2020.0223. Epub 2020 Jul 6.
- Background: PubMed 29716513Schaeffer EK, Study Group I, Mulpuri K. Developmental dysplasia of the hip: addressing evidence gaps with a multicentre prospective international study. Med J Aust. 2018 May 7;208(8):359-364. doi: 10.5694/mja18.00154.
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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.
ahmed khashaba, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Al-Azhar 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 5 inclusion and 3 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 3 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed khashaba, MD (01023233949), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified 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 NCT05603858, 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 3 Nov 2022.