Developmental Dysplasia of the HipNCT06439147
Comparison Between Two Techniques of Capsulotomy During Capsulorrhaphy in Cases of Developmental Dysplasia of the Hip
A study testing U shaped capsular incision during capsulorrhaphy and T-shaped capsular incision diuring capsulorraphy in people with Developmental Dysplasia of the Hip, run by Assiut University at 1 site in Egypt.
Trial summary
comparison of the outcome between using U-shaped incision and T-shaped incision for capsulorrhaphy in management of Developmental dysplasia of the hip Read more about this study
- Who is it for?
- Ages 1 year to 4 years
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- U shaped capsular incision during capsulorrhaphy and T-shaped capsular incision diuring capsulorraphy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 6 May 2026
- 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 1 year to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients older than 1 year and younger than 4 years
- Unilateral or bilateral cases
Who cannot join
- Patients younger than 1 year and older than 4 years old
- Secondary hip dislocation ,neuromuscular disorders (as cerebral palsy, myelodysplasia or arthrogryposis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: U-shaped Versus T-shaped Capsular Incision in Capsulorrhaphy During Surgery for Developmental Dysplasia of the Hip, A Randomized Controlled Trial
comparison of the outcome between using U-shaped incision and T-shaped incision for capsulorrhaphy in management of Developmental dysplasia of the hip
Read the detailed description
Developmental dysplasia of the hip: Developmental dysplasia of the hip is a spectrum of abnormalities of the developing hip joint that ranges from shallowness of the acetabulum to capsular laxity and instability to frank dislocation . Developmental dysplasia of the hip is relatively common, occurring in 1 of 1000 live births.
When surgical intervention is decided, open reduction is needed to remove any obstacle that hinders hip reduction. Capsulorrhaphy is an essential step for minimizing instability of the hip after reduction The classic T-shaped capsular incision is done by two incisions: Vertical limb parallel to femoral neck axis and a transverse one parallel to the inguinal ligament resulting into two layers . Suturing them back is somewhat cumbersome after femoral head reduction. Therefore, the suggested technique utilizes a U-shaped incision to make re-suturing of the capsule easier with multiple stitches, and this study compares the outcome between using T-shaped incision and U-shaped incision for capsulorrhaphy after open reduction Femoral osteotomy or Pelvic osteotomy can be used in certain circumstances.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- U shaped capsular incision during capsulorrhaphy, T-shaped capsular incision diuring capsulorraphy
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U shaped capsular incision during capsulorrhaphyProcedure or surgery
Also called U-shaped Capsulotomy
Incision of the capsule of the hip during open reduction of Developmental Dysplasia of the Hip,Incision is done with its base proximally. The transverse limb is 1 cm proximal to femoral neck base
T-shaped capsular incision diuring capsulorraphyProcedure or surgery
Also called T-shaped Capsulotomy
Incision of the capsule of the hip during open reduction of Developmental Dysplasia of the Hip done by two incisions: Vertical limb parallel to femoral neck axis and a transverse one parallel to the inguinal ligament resulting into two flabs.
| Study group | Role | What they receive |
|---|---|---|
| U-shaped group | Active comparator | Participants on which U shaped capsular incision will be used during capsulorrhaphy Receives: Procedure: U shaped capsular incision during capsulorrhaphy |
| T-shaped group | Active comparator | Participants on which T shaped incision will be used during capsulorrhaphy Receives: Procedure: T-shaped capsular incision diuring capsulorraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time of capsulorrhaphy
calculate the time needed to close the capsule of the hip
Measured: 1 year
Number of stitches taken during capsulorrhaphy
Measured: 1 year
Secondary outcomes (2)
Modified Mackay's criteria as a clinical evaluation method
Postoperative clinical evaluation Grade 1(Excellent):Painless,stable hip,no limp,more than 15 degrees of internal rotation Grade 2(Good):Painless,stable hip,slight limp or decreased motion;negative trendelenburg's sign Grade 3(Fair):Minimum pain,moderate stiffness;Positive trendelenburg sign Grade 4(Poor):Significant pain
Measured: 1 year
any complication detected
- Sublaxation
- Recurrent dislocation
- proximal femoral growth disturbance
- Supracondylar femoral fracture
- Infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Apr 2024
- Primary completion5 May 2025
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of the HipStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Thabet Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439147
- Sponsor's protocol ID
- Capsulorrhaphy in DDH
- Status last verified
- Jun 2026
- First submitted
- 23 May 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McKay DW. A comparison of the innominate and the pericapsular osteotomy in the treatment of congenital dislocation of the hip. Clin Orthop Relat Res. 1974 Jan-Feb;(98):124-32. doi: 10.1097/00003086-197401000-00013. No abstract available.
PubMed 4817221Glorion C. Surgical reduction of congenital hip dislocation. Orthop Traumatol Surg Res. 2018 Feb;104(1S):S147-S157. doi: 10.1016/j.otsr.2017.04.021. Epub 2017 Dec 2.
PubMed 29203431Elbaseet HM, Abdelzaher MA. U-shaped hip capsular incision: An easier way to do hip capsulorrhaphy in developmental dysplasia of the hip - Technical note. Orthop Traumatol Surg Res. 2024 Jun;110(4):103625. doi: 10.1016/j.otsr.2023.103625. Epub 2023 Apr 21.
PubMed 37086945Zargarbashi R, Bozorgmanesh M, Panjavi B, Vosoughi F. The path to minimizing instability in developmental dysplasia of the hip: is Capsulorrhaphy a necessity or a futile habit? BMC Musculoskelet Disord. 2021 Feb 17;22(1):199. doi: 10.1186/s12891-021-04065-3.
PubMed 33596895Li Y, Hu W, Xun F, Lin X, Li J, Yuan Z, Liu Y, Canavese F, Xu H. Risk factors associated with unsatisfactory hip function in children with late-diagnosed developmental dislocation of the hip treated by open reduction. Orthop Traumatol Surg Res. 2020 Nov;106(7):1373-1381. doi: 10.1016/j.otsr.2020.03.018. Epub 2020 Jun 19.
PubMed 32571742
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U-shaped Versus T-shaped Capsular Incision in Capsulorrhaphy During Surgery for Developmental Dysplasia of the Hip, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06439147
- Acronym / sponsor ID
- Capsulorrhaphy in DDH
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 3 Jun 2024 (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.
comparison of the outcome between using U-shaped incision and T-shaped incision for capsulorrhaphy in management of Developmental dysplasia of the hip
Detailed description
Developmental dysplasia of the hip: Developmental dysplasia of the hip is a spectrum of abnormalities of the developing hip joint that ranges from shallowness of the acetabulum to capsular laxity and instability to frank dislocation . Developmental dysplasia of the hip is relatively common, occurring in 1 of 1000 live births.
When surgical intervention is decided, open reduction is needed to remove any obstacle that hinders hip reduction. Capsulorrhaphy is an essential step for minimizing instability of the hip after reduction The classic T-shaped capsular incision is done by two incisions: Vertical limb parallel to femoral neck axis and a transverse one parallel to the inguinal ligament resulting into two layers . Suturing them back is somewhat cumbersome after femoral head reduction. Therefore, the suggested technique utilizes a U-shaped incision to make re-suturing of the capsule easier with multiple stitches, and this study compares the outcome between using T-shaped incision and U-shaped incision for capsulorrhaphy after open reduction Femoral osteotomy or Pelvic osteotomy can be used in certain circumstances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| U-shaped group | Active comparator | Procedure: U shaped capsular incision during capsulorrhaphyParticipants on which U shaped capsular incision will be used during capsulorrhaphy |
| T-shaped group | Active comparator | Procedure: T-shaped capsular incision diuring capsulorraphyParticipants on which T shaped incision will be used during capsulorrhaphy |
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients older than 1 year and younger than 4 years
- Unilateral or bilateral cases
Key exclusion criteria (2 listed)
- Patients younger than 1 year and older than 4 years old
- Secondary hip dislocation ,neuromuscular disorders (as cerebral palsy, myelodysplasia or arthrogryposis).
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 |
|---|---|---|
| U shaped capsular incision during capsulorrhaphyAlso: U-shaped CapsulotomyIncision of the capsule of the hip during open reduction of Developmental Dysplasia of the Hip,Incision is done with its base proximally. The transverse limb is 1 cm proximal to femoral neck base | Procedure or surgery | U-shaped group |
| T-shaped capsular incision diuring capsulorraphyAlso: T-shaped CapsulotomyIncision of the capsule of the hip during open reduction of Developmental Dysplasia of the Hip done by two incisions: Vertical limb parallel to femoral neck axis and a transverse one parallel to the inguinal ligament resulting into two flabs. | Procedure or surgery | T-shaped group |
Primary outcome
Operative time of capsulorrhaphy
Time frame: 1 year
calculate the time needed to close the capsule of the hip
Number of stitches taken during capsulorrhaphy
Time frame: 1 year
2 secondary outcomes
Modified Mackay's criteria as a clinical evaluation method
Time frame: 1 year
any complication detected
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 4817221McKay DW. A comparison of the innominate and the pericapsular osteotomy in the treatment of congenital dislocation of the hip. Clin Orthop Relat Res. 1974 Jan-Feb;(98):124-32. doi: 10.1097/00003086-197401000-00013. No abstract available.
- Background: PubMed 29203431Glorion C. Surgical reduction of congenital hip dislocation. Orthop Traumatol Surg Res. 2018 Feb;104(1S):S147-S157. doi: 10.1016/j.otsr.2017.04.021. Epub 2017 Dec 2.
- Background: PubMed 37086945Elbaseet HM, Abdelzaher MA. U-shaped hip capsular incision: An easier way to do hip capsulorrhaphy in developmental dysplasia of the hip - Technical note. Orthop Traumatol Surg Res. 2024 Jun;110(4):103625. doi: 10.1016/j.otsr.2023.103625. Epub 2023 Apr 21.
- Background: PubMed 33596895Zargarbashi R, Bozorgmanesh M, Panjavi B, Vosoughi F. The path to minimizing instability in developmental dysplasia of the hip: is Capsulorrhaphy a necessity or a futile habit? BMC Musculoskelet Disord. 2021 Feb 17;22(1):199. doi: 10.1186/s12891-021-04065-3.
- Background: PubMed 32571742Li Y, Hu W, Xun F, Lin X, Li J, Yuan Z, Liu Y, Canavese F, Xu H. Risk factors associated with unsatisfactory hip function in children with late-diagnosed developmental dislocation of the hip treated by open reduction. Orthop Traumatol Surg Res. 2020 Nov;106(7):1373-1381. doi: 10.1016/j.otsr.2020.03.018. Epub 2020 Jun 19.
- Smith's anesthesia for infants and childrenLink provided by the sponsor.
- 6-Articular mobility in an African population.Link provided by the sponsor.
- 7-persistent joint laxity and congenital dislocation of the hipLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U shaped capsular incision during capsulorrhaphy and T-shaped capsular incision diuring capsulorraphy in people with Developmental Dysplasia of the Hip, run by Assiut 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 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: finished, as of the sponsor's last update on 25 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Operative time of capsulorrhaphy (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06439147, which also lists 5 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 25 Jun 2026.