Hip DysplasiaNCT03193385
Treatment of Developmental Dysplasia of the HIp
An observational study of Hip Dysplasia, run by Assiut University.
Trial summary
Closed reduction is where the thigh bone is placed into the socket without any surgical incision being made. This is more likely to be performed in a child under the age of four year. The femoral head is gently manipulated into the socket, whilst the child is under anaesthetic. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Hip Dysplasia
- What is being tested?
- closed reduction
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Jul 2020
- 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 6 months to 4 years
- All sexes
- Child
Study population: closed reduction of the neglected hip dyplasia The purpose of this study to identify predictive factors that would best indicate the satisfactory function and radiological outcome after close redaction of developmentlal dysplasia of the hip in children
Who may be able to join
- Children that missed the initial diagnosis after birth and presented around six months up to four years which included in this study. All patients did not receive prior treatment such as Pavlik harness or splints.
Who cannot join
- Patients with neurological, septic, traumatic or syndromatic dislocation is not included in our study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Closed Reduction for Treatment of Developmental Dysplasia of the Hip in Children
Closed reduction is where the thigh bone is placed into the socket without any surgical incision being made. This is more likely to be performed in a child under the age of four year. The femoral head is gently manipulated into the socket, whilst the child is under anaesthetic. Once the femoral head is in place, a hip Spica is applied and can remain in place for up to three months to maintain the hip in the correct position. This allows time for healing and for the socket and the thigh bone to mould together as a joint.
The purpose of this study was to identify and evaluate risk factors of avascular necrosis (AVN) after closed treatment for developmental dysplasia of the hip (DDH).
assessed according to Salter's classification system.
Read the detailed description
Technique of closed reduction Preoperative Patients were admitted one day before operation in the pediatric ward and when possible skin traction was applied for the affected side. Blood sample was extracted for basic lab work investigations Blood bank was contacted to prepare cross matching for blood in case of shifting the procedure to open reduction. The side of DDH was marked and patient kept fasting starting from midnight before operation.The consent was signed by the legal guardian and we included the possibility of turning closed to open reduction in case of failure to obtain concentric reduction intraoperatively Operative technique After induction of general anesthesia with proper muscle relaxant,the patient was examined gently for hip mobility and possibility of closed reduction.Vigorous maneuvers were avoided.The hip was reduced by placing it in flexion beyond 90 degrees and gradually abducting it while gently lifting the greater trochanter, as is done during the Ortolani maneuver. The minimum possible force was applied and after a palpable reduction was felt, the hip was moved to determine the range of motion in which it remained reduce as described by Ramsey and associates. The hip was adducted to the point of redislocation, and that position was noted. The hip was again reduced and then extended until it dislocates, and the point of dislocation was noted. If the hip required internal rotation to maintain reduction, this was also noted
Tenotomy
At times, an adductor tenotomy was used to increase the safe zone by allowing for a wider range of abduction. However,wide abduction should never be used because It is known that this can predispose to AVN.Excessive internal rotation is also a known cause of AVN and thus must be avoided.A percutaneous adductor tenotomy under sterile conditions was performed for mild adduction contractures. For more severe adduction contracture or one of long duration,an open adductor tenotomy through a small transverse incision was done
Technique of cast application Closed reduction of the hip should be performed under general anesthesia in the operating room to provide adequate muscle paralysis. The reduction maneuver involves longitudinal traction, flexion, and abduction of the hip, all while applying posterior pressure on the greater trochanter [12]. Frequently an adductor tenotomy is necessary via an open or percutaneous technique, which relieves one of the opposing forces and widens the "safe zone." After reduction of the hip, intraoperative arthrography will confirm a concentric reduction of the femoral head by demonstrating a collection of dye in the space between the femoral head and medial border of the acetabulum of less than 5-7 mm [13]. The previously described collection of dye is often referred to as the "medial dye pool." If the medial dye pool measures greater than 7 mm, it is an indication to proceed with an open reduction [13]. Once reduction of the hip has been documented, the stable zones of the hip in all planes of direction (abduction/adduction, flexion/extension, internal/ external rotation) should be identified to ensure stability of the hip in the "human position" prior to applying the spica cast. The purpose of the spica cast is to maintain the hip in 100 of flexion and 40-50 of abduction, which is commonly referred to as the "human position" of the hip . The spica cast is technically demanding, but close attention to detail can ensure hip positioning and maintenance of the reduction. Because the padding over the anterior aspect of the hip has a tendency to extend the hip, it is prudent to maintain necessary flexion until the casting material has hardened. The femoral head will often migrate posteriorly leading to a loss in the reduction, but the use of a greater trochanter mold can help prevent the migration .
Confirming of closed reduction by arthrography inter operative and C T /MRI post-operative
- Conditions
- Hip Dysplasia
- Being tested
- closed reduction
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed reductionProcedure or surgery
Closed reduction is where the thigh bone is placed into the socket without any surgical incision being made. This is more likely to be performed in a child under the age of four year. The femoral head is gently manipulated into the socket, whilst the child is under anaesthetic. Once the femoral head is in place, a hip Spica is applied and can remain in place for up to three months to maintain the hip in the correct position. This allows time for healing and for the socket and the thigh bone to mould together as a joint.
| Study group | Role | What they receive |
|---|---|---|
| Closed reduction | Not described Receives: Procedure: closed reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip score
harris hip score for function of the hip
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study startJul 2017 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
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 Hip DysplasiaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Abdelmaged Abdelqawi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193385
- Sponsor's protocol ID
- DDH
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anuar R, Mohd-Hisyamudin HP, Ahmad MH, Zulkiflee O. The Economic Impact of Managing Late Presentation of Developmental Dysplasia of Hip (DDH). Malays Orthop J. 2015 Nov;9(3):40-43. doi: 10.5704/MOJ.1511.006.
PubMed 28611908de Hundt M, Vlemmix F, Bais JM, Hutton EK, de Groot CJ, Mol BW, Kok M. Risk factors for developmental dysplasia of the hip: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):8-17. doi: 10.1016/j.ejogrb.2012.06.030. Epub 2012 Jul 21.
PubMed 22824571Brady RJ, Dean JB, Skinner TM, Gross MT. Limb length inequality: clinical implications for assessment and intervention. J Orthop Sports Phys Ther. 2003 May;33(5):221-34. doi: 10.2519/jospt.2003.33.5.221.
PubMed 12774997Sarkissian EJ, Sankar WN, Baldwin K, Flynn JM. Is there a predilection for breech infants to demonstrate spontaneous stabilization of DDH instability? J Pediatr Orthop. 2014 Jul-Aug;34(5):509-13. doi: 10.1097/BPO.0000000000000134.
PubMed 24590335Race C, Herring JA. Congenital dislocation of the hip: an evaluation of closed reduction. J Pediatr Orthop. 1983 May;3(2):166-72. doi: 10.1097/01241398-198305000-00004.
PubMed 6863522
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Closed Reduction for Treatment of Developmental Dysplasia of the Hip in Children
- ClinicalTrials.gov ID
- NCT03193385
- Acronym / sponsor ID
- DDH
- Conditions
- Hip Dysplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 20 Jun 2017 (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.
Closed reduction is where the thigh bone is placed into the socket without any surgical incision being made. This is more likely to be performed in a child under the age of four year. The femoral head is gently manipulated into the socket, whilst the child is under anaesthetic. Once the femoral head is in place, a hip Spica is applied and can remain in place for up to three months to maintain the hip in the correct position. This allows time for healing and for the socket and the thigh bone to mould together as a joint.
The purpose of this study was to identify and evaluate risk factors of avascular necrosis (AVN) after closed treatment for developmental dysplasia of the hip (DDH).
assessed according to Salter's classification system.
Detailed description
Technique of closed reduction Preoperative Patients were admitted one day before operation in the pediatric ward and when possible skin traction was applied for the affected side. Blood sample was extracted for basic lab work investigations Blood bank was contacted to prepare cross matching for blood in case of shifting the procedure to open reduction. The side of DDH was marked and patient kept fasting starting from midnight before operation.The consent was signed by the legal guardian and we included the possibility of turning closed to open reduction in case of failure to obtain concentric reduction intraoperatively Operative technique After induction of general anesthesia with proper muscle relaxant,the patient was examined gently for hip mobility and possibility of closed reduction.Vigorous maneuvers were avoided.The hip was reduced by placing it in flexion beyond 90 degrees and gradually abducting it while gently lifting the greater trochanter, as is done during the Ortolani maneuver. The minimum possible force was applied and after a palpable reduction was felt, the hip was moved to determine the range of motion in which it remained reduce as described by Ramsey and associates. The hip was adducted to the point of redislocation, and that position was noted. The hip was again reduced and then extended until it dislocates, and the point of dislocation was noted. If the hip required internal rotation to maintain reduction, this was also noted
Tenotomy
At times, an adductor tenotomy was used to increase the safe zone by allowing for a wider range of abduction. However,wide abduction should never be used because It is known that this can predispose to AVN.Excessive internal rotation is also a known cause of AVN and thus must be avoided.A percutaneous adductor tenotomy under sterile conditions was performed for mild adduction contractures. For more severe adduction contracture or one of long duration,an open adductor tenotomy through a small transverse incision was done
Technique of cast application Closed reduction of the hip should be performed under general anesthesia in the operating room to provide adequate muscle paralysis. The reduction maneuver involves longitudinal traction, flexion, and abduction of the hip, all while applying posterior pressure on the greater trochanter [12]. Frequently an adductor tenotomy is necessary via an open or percutaneous technique, which relieves one of the opposing forces and widens the "safe zone." After reduction of the hip, intraoperative arthrography will confirm a concentric reduction of the femoral head by demonstrating a collection of dye in the space between the femoral head and medial border of the acetabulum of less than 5-7 mm [13]. The previously described collection of dye is often referred to as the "medial dye pool." If the medial dye pool measures greater than 7 mm, it is an indication to proceed with an open reduction [13]. Once reduction of the hip has been documented, the stable zones of the hip in all planes of direction (abduction/adduction, flexion/extension, internal/ external rotation) should be identified to ensure stability of the hip in the "human position" prior to applying the spica cast. The purpose of the spica cast is to maintain the hip in 100 of flexion and 40-50 of abduction, which is commonly referred to as the "human position" of the hip . The spica cast is technically demanding, but close attention to detail can ensure hip positioning and maintenance of the reduction. Because the padding over the anterior aspect of the hip has a tendency to extend the hip, it is prudent to maintain necessary flexion until the casting material has hardened. The femoral head will often migrate posteriorly leading to a loss in the reduction, but the use of a greater trochanter mold can help prevent the migration .
Confirming of closed reduction by arthrography inter operative and C T /MRI post-operative
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed reduction | – | Procedure: closed reduction |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Age groups
- Child
- Study population
- closed reduction of the neglected hip dyplasia The purpose of this study to identify predictive factors that would best indicate the satisfactory function and radiological outcome after close redaction of developmentlal dysplasia of the hip in children
Key inclusion criteria (1 listed)
- Children that missed the initial diagnosis after birth and presented around six months up to four years which included in this study. All patients did not receive prior treatment such as Pavlik harness or splints.
Key exclusion criteria (1 listed)
- Patients with neurological, septic, traumatic or syndromatic dislocation is not included in our study.
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 |
|---|---|---|
| closed reductionClosed reduction is where the thigh bone is placed into the socket without any surgical incision being made. This is more likely to be performed in a child under the age of four year. The femoral head is gently manipulated into the socket, whilst the child is under anaesthetic. Once the femoral head is in place, a hip Spica is applied and can remain in place for up to three months to maintain the hip in the correct position. This allows time for healing and for the socket and the thigh bone to mould together as a joint. | Procedure or surgery | Closed reduction |
Primary outcome
Harris Hip score
Time frame: 6 month
harris hip 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 20 Jun 2017.
- Background: PubMed 28611908Anuar R, Mohd-Hisyamudin HP, Ahmad MH, Zulkiflee O. The Economic Impact of Managing Late Presentation of Developmental Dysplasia of Hip (DDH). Malays Orthop J. 2015 Nov;9(3):40-43. doi: 10.5704/MOJ.1511.006.
- Background: PubMed 22824571de Hundt M, Vlemmix F, Bais JM, Hutton EK, de Groot CJ, Mol BW, Kok M. Risk factors for developmental dysplasia of the hip: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):8-17. doi: 10.1016/j.ejogrb.2012.06.030. Epub 2012 Jul 21.
- Background: PubMed 12774997Brady RJ, Dean JB, Skinner TM, Gross MT. Limb length inequality: clinical implications for assessment and intervention. J Orthop Sports Phys Ther. 2003 May;33(5):221-34. doi: 10.2519/jospt.2003.33.5.221.
- Background: PubMed 24590335Sarkissian EJ, Sankar WN, Baldwin K, Flynn JM. Is there a predilection for breech infants to demonstrate spontaneous stabilization of DDH instability? J Pediatr Orthop. 2014 Jul-Aug;34(5):509-13. doi: 10.1097/BPO.0000000000000134.
- Background: PubMed 6863522Race C, Herring JA. Congenital dislocation of the hip: an evaluation of closed reduction. J Pediatr Orthop. 1983 May;3(2):166-72. doi: 10.1097/01241398-198305000-00004.
- Individual participant dataSharing planned: No
Related trials for Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Dysplasia, 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 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 20 Jun 2017. 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 abdel-khalek Hafez ibrahim, MD (0201222302088, ortho2015@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip score (time frame: 6 month). 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 NCT03193385, 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 20 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.