Orthopaedic SurgeryNCT07356921
Ligamentum Teres in Management of Developmental Hip Dysplasia
An observational study of Orthopaedic Surgery, run by Assiut University.
Trial summary
Treatment of developmental dysplasia of the hip (DDH) is still challenging, till now there is no any recent advances have refined our understanding of how best to survey for the condition during infancy and refine the selection of patients who can best benefit from hip preservation surgery. Read more about this study
- Who is it for?
- Ages 9 months to 5 years
- Conditions the study is for
- Orthopaedic Surgery
- What is being tested?
- ligamentum teres tenodesis
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 1 Oct 2026
- Phase
- Observational
- 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 9 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Operation was done under general anesthesia and patient in supine position. Sterilization was done. Incision was made from anterior half of iliac crest to ASIS (the anterior or anterolateral Smith-Petersen approach with a modified "bikini" incision) .Superficial dissection was done by identify gap between sartorius and tensor fasciae latae, dissect through subcutaneous fat (avoid lateral femoral cutaneous n.), incise fascia on medial side of tensor fascia latae and detach origin of tensor fasciae latae of iliac to develop internervous plane. Deep dissection was done by identify plane between rectus femoris and gluteus medius and detaches rectus femoris from both its origins.
Who may be able to join
- Virgin developmental dysplasia of the hip (DDH)
- failed closed reduction in the management of DDH and failed open reduction through medial approach in the management of DDH
Who cannot join
- cases that managed previously through anterior approach
- old neglected cases above 5 years old children
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: Function of Ligamentum Teres in Management of Developmental Hip Dysplasia (DDH)
Treatment of developmental dysplasia of the hip (DDH) is still challenging, till now there is no any recent advances have refined our understanding of how best to survey for the condition during infancy and refine the selection of patients who can best benefit from hip preservation surgery.
Read the detailed description
Concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage are leading to adequate growth and development of the hip. Any alteration in these two conditions leads to a hip dysplasia \& dislocation .
Treatment of developmental dysplasia of the hip (DDH) is still challenging, till now there is no any recent advances have refined our understanding of how best to survey for the condition during infancy 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, decrease the incidence of total hip arthroplasty in adulthood related to undertreat DDH and prevent avascular necrosis (AVN).
The goal of the treatment is to achieve a concentric reduction of the femoral head into the acetabulum.
- Conditions
- Orthopaedic Surgery
- Being tested
- ligamentum teres tenodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ligamentum teres tenodesisProcedure or surgery
- Creating a tract or tunnel: from acetabulum cavity to intra pelvic cavity using bit (3.5mm or 4.5mm according to the size of the ligament) or k wire (3mm) from the site of the ligamentum attached at the acetabulum guided with passer
- Passing of the sutured ligamentum teres through the tunnel
- Tighting of the passed sutured ligamentum teres
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Harris Hip Score
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 posted21 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (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 Orthopaedic SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaaeldin Mohamed Abdelhafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356921
- Sponsor's protocol ID
- LTDDH
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bache CE, Graham HK, Dickens DR, Donnan L, Johnson MB, Nattrass G, O'Sullivan M, Torode IP. Ligamentum teres tenodesis in medial approach open reduction for developmental dislocation of the hip. J Pediatr Orthop. 2008 Sep;28(6):607-13. doi: 10.1097/BPO.0b013e318184202c.
PubMed 18724195Wenger DR, Mubarak SJ, Henderson PC, Miyanji F. Ligamentum teres maintenance and transfer as a stabilizer in open reduction for pediatric hip dislocation: surgical technique and early clinical results. J Child Orthop. 2008 Jun;2(3):177-85. doi: 10.1007/s11832-008-0103-3. Epub 2008 Apr 29.
PubMed 19308575
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function of Ligamentum Teres in Management of Developmental Hip Dysplasia (DDH)
- ClinicalTrials.gov ID
- NCT07356921
- Acronym / sponsor ID
- LTDDH
- Conditions
- Orthopaedic Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
Treatment of developmental dysplasia of the hip (DDH) is still challenging, till now there is no any recent advances have refined our understanding of how best to survey for the condition during infancy and refine the selection of patients who can best benefit from hip preservation surgery.
Detailed description
Concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage are leading to adequate growth and development of the hip. Any alteration in these two conditions leads to a hip dysplasia \& dislocation .
Treatment of developmental dysplasia of the hip (DDH) is still challenging, till now there is no any recent advances have refined our understanding of how best to survey for the condition during infancy 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, decrease the incidence of total hip arthroplasty in adulthood related to undertreat DDH and prevent avascular necrosis (AVN).
The goal of the treatment is to achieve a concentric reduction of the femoral head into the acetabulum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Operation was done under general anesthesia and patient in supine position. Sterilization was done. Incision was made from anterior half of iliac crest to ASIS (the anterior or anterolateral Smith-Petersen approach with a modified "bikini" incision) .Superficial dissection was done by identify gap between sartorius and tensor fasciae latae, dissect through subcutaneous fat (avoid lateral femoral cutaneous n.), incise fascia on medial side of tensor fascia latae and detach origin of tensor fasciae latae of iliac to develop internervous plane. Deep dissection was done by identify plane between rectus femoris and gluteus medius and detaches rectus femoris from both its origins.
Key inclusion criteria (2 listed)
- Virgin developmental dysplasia of the hip (DDH)
- failed closed reduction in the management of DDH and failed open reduction through medial approach in the management of DDH
Key exclusion criteria (2 listed)
- cases that managed previously through anterior approach
- old neglected cases above 5 years old children
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 tenodesis* Creating a tract or tunnel: from acetabulum cavity to intra pelvic cavity using bit (3.5mm or 4.5mm according to the size of the ligament) or k wire (3mm) from the site of the ligamentum attached at the acetabulum guided with passer * Passing of the sutured ligamentum teres through the tunnel * Tighting of the passed sutured ligamentum teres | Procedure or surgery | – |
Primary outcome
modified Harris Hip Score
Time frame: 6 months
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 21 Jan 2026.
- Background: PubMed 18724195Bache CE, Graham HK, Dickens DR, Donnan L, Johnson MB, Nattrass G, O'Sullivan M, Torode IP. Ligamentum teres tenodesis in medial approach open reduction for developmental dislocation of the hip. J Pediatr Orthop. 2008 Sep;28(6):607-13. doi: 10.1097/BPO.0b013e318184202c.
- Background: PubMed 19308575Wenger DR, Mubarak SJ, Henderson PC, Miyanji F. Ligamentum teres maintenance and transfer as a stabilizer in open reduction for pediatric hip dislocation: surgical technique and early clinical results. J Child Orthop. 2008 Jun;2(3):177-85. doi: 10.1007/s11832-008-0103-3. Epub 2008 Apr 29.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopaedic Surgery, 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 2 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 21 Jan 2026. 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 bahaaeldin Mohamed Bahaaeldin Ibrahim, MD (0201006895757, Bahaa_ortho@yahoo.com), 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 NCT07356921, 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 21 Jan 2026.