NCT03193385

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

June 16, 2017

Last Update Submit

June 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Harris Hip score

    harris hip score for function of the hip

    6 month

Study Arms (1)

Closed reduction

Procedure: closed reduction

Interventions

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.

Closed reduction

Eligibility Criteria

Age6 Months - 4 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 28611908BACKGROUND
  • de 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.

    PMID: 22824571BACKGROUND
  • Brady 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.

    PMID: 12774997BACKGROUND
  • Sarkissian 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.

    PMID: 24590335BACKGROUND
  • Race 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.

    PMID: 6863522BACKGROUND

MeSH Terms

Conditions

Hip Dislocation

Interventions

Closed Fracture Reduction

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeutics

Central Study Contacts

abdel-khalek Hafez ibrahim, MD

CONTACT

Nariman aboloyoun, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 20, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share