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Treatment of Developmental Dysplasia of the HIp

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ClinicalTrials.gov Identifier: NCT03193385
Recruitment Status : Not yet recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Emad Abdelmaged Abdelqawi, Assiut University

Brief 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. 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.


Condition or disease Intervention/treatment
Hip Dysplasia Procedure: closed reduction

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


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Closed Reduction for Treatment of Developmental Dysplasia of the Hip in Children
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Group/Cohort Intervention/treatment
Closed reduction Procedure: closed reduction
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.




Primary Outcome Measures :
  1. Harris Hip score [ Time Frame: 6 month ]
    harris hip score for function of the hip



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Ages Eligible for Study:   6 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with neurological, septic, traumatic or syndromatic dislocation is not included in our study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193385


Contacts
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Contact: abdel-khalek Hafez ibrahim, MD 0201222302088 ortho2015@yahoo.com
Contact: Nariman aboloyoun, MD 0201222302343 Aboloyoun@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Emad Abdelmaged Abdelqawi, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03193385     History of Changes
Other Study ID Numbers: DDH
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hip Dislocation
Hip Dislocation, Congenital
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities