Orthopedic DisorderNCT05432505
Ligamentum Teres Tenodesis in Developmental Dysplasia of the Hip
An observational study of Orthopedic Disorder, run by Al-Azhar University.
Trial summary
The treatment of developmental dysplasia of the hip (DDH) remains challenging, yet recent advances have refined our understanding of how best to survey for the condition during infancy, minimize complications during early treatment, and refine the selection of patients who can best benefit from hip preservation… Read more about this study
- Who is it for?
- Ages 9 to 60 months
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- ligamentum teres tenodesis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2022to Feb 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 9 to 60 months
- All sexes
- Child
Study population: The patients will be examined for: 1. Length of both lower limbs in relation to each other. 2. Length of both lower limbs according to patient age. 3. Presence of hump related to the outer surface of the hip 4. 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. Identification of ligamentum teres 2. ligamentum teres tenodesis
Who may be able to join
- Patient with Developmental dysplasia of the hip (DDH) with :
- Age: from 9 months -5 years old.
- Virgin DDH.
- Failed closed reduction in the management of DDH.
- Failed open reduction through medial approach in the management of DDH
Who cannot join
- • Paralytic hip dislocation .
- Post septic hip dislocation.
- Traumatic hip dislocation .
- Age : below 9 months or above 5 years.
- Refusal to participate in this study.
About this study
Official title: The Role of Ligamentum Teres Tenodesis in the Management of Developmental Dysplasia of the Hip
The treatment of developmental dysplasia of the hip (DDH) remains challenging, yet recent advances have refined our understanding of how best to survey for the condition during infancy, minimize complications during early treatment, and refine the selection of patients who can best benefit from hip preservation surgery. The ideal continued target would be to prevent missed hip dislocations or dysplasia during the infant period, prevent avascular necrosis (AVN) during early treatment, and decrease the incidence of total hip arthroplasty in adulthood related to undertreated DDH, The goal of the treatment is to achieve a concentric reduction of the femoral head into the acetabulum.
Read the detailed description
it is an operative technique to secure the femoral head after reduction in cases of developmental dysplasia of the hip
Operative technique:
The surgery will be accomplished under a general anesthesia.
An addition to the steps of the open reduction, the following were done:
- Identification of ligamentum teres
- ligamentum teres tenodesis
- Conditions
- Orthopedic Disorder
- Being tested
- ligamentum teres tenodesis
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ligamentum teres tenodesisOther
Identification of ligamentum teres ligamentum teres tenodesis
What is being measured
The primary outcome is the main question the study is designed to answer.
modified HHS
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 posted27 Jun 2022
- Study start21 Jul 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionFeb 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 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
- NCT05432505
- Sponsor's protocol ID
- LTT
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- 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 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ligamentum Teres Tenodesis in the Management of Developmental Dysplasia of the Hip
- ClinicalTrials.gov ID
- NCT05432505
- Acronym / sponsor ID
- LTT
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 21 Jul 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 27 Jun 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.
The treatment of developmental dysplasia of the hip (DDH) remains challenging, yet recent advances have refined our understanding of how best to survey for the condition during infancy, minimize complications during early treatment, and refine the selection of patients who can best benefit from hip preservation surgery. The ideal continued target would be to prevent missed hip dislocations or dysplasia during the infant period, prevent avascular necrosis (AVN) during early treatment, and decrease the incidence of total hip arthroplasty in adulthood related to undertreated DDH, The goal of the treatment is to achieve a concentric reduction of the femoral head into the acetabulum.
Detailed description
it is an operative technique to secure the femoral head after reduction in cases of developmental dysplasia of the hip
Operative technique:
The surgery will be accomplished under a general anesthesia.
An addition to the steps of the open reduction, the following were done:
- Identification of ligamentum teres
- ligamentum teres tenodesis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 60 months
- Sex
- All
- Age groups
- Child
- Study population
- The patients will be examined for: 1. Length of both lower limbs in relation to each other. 2. Length of both lower limbs according to patient age. 3. Presence of hump related to the outer surface of the hip 4. 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. Identification of ligamentum teres 2. ligamentum teres tenodesis
Key inclusion criteria (5 listed)
- Patient with Developmental dysplasia of the hip (DDH) with :
Key exclusion criteria (5 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 |
|---|---|---|
| ligamentum teres tenodesisIdentification of ligamentum teres ligamentum teres tenodesis | Other | – |
Primary outcome
modified HHS
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 27 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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: status not confirmed, as of the sponsor's last update on 27 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified HHS (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 NCT05432505, 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 27 Jun 2022.