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Level of Iliopsoas Tenotomy in DDH Surgery

NCT ID: NCT06742749

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-02

Study Completion Date

2024-12-27

Brief Summary

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The goal of this clinical trial is to compare the postoperative clinical outcome of iliopsoas tenotomy in open reduction operation for developmental dysplasia of the hip. The main aim is to compare the postoperative clinical outcome of division of iliopsoas tendon at two levels, proximally at the pelvic brim and distally just above the lesser trochanter.

Detailed Description

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All the patients with DDH included in the current study underwent open reduction of their dislocated hip through the anterior approach. None of the included patients underwent hip surgery through the medial approach.

For the proximal level of psoas tenotomy at the pelvic brim, the hip was slightly flexed to relax the iliopsoas muscle; the iliacus muscle fibers were retracted anteriorly until the deeply seated posteromedially psoas tendon was isolated and transected. For the distal level of iliopsoas tenotomy just above the lesser trochanter, the thigh was put in the position of FABER (flexion, abduction, and external rotation). A curved right-angle hemostatic clamp was used to retract and bring the iliopsoas tendon into the field. Then, the tendinous fibers were transected.

Conditions

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Developmental Dysplasia of the Hip (DDH)

Keywords

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Hip Developmental Dysplasia of the hip surgical treatment Iliopsoas Tenotomy Randomized Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was a randomized clinical trial. It was done to check the equivalence between two parallel groups of patients with DDH who underwent open reduction operation for their hips. In the first group, the psoas tendon was sectioned at the pelvic brim (proximal level), while in the second group, the section of the tendon was done just above the lesser trochanter (distal level). The allocation ratio was 1:1.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patients, their parents/guardians, and the person who assessed the primary outcome were blinded to the type of intervention and the randomization sequence. The primary outcome assessor was a physiotherapist already trained in rehabilitating children with orthopedic disorders and the manual muscle strength testing scale. The assessment of the primary outcome was done in the physiotherapy department of the EDCD center.

Study Groups

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Group 1

For the proximal level of psoas tenotomy at the pelvic brim, the hip was slightly flexed to relax the iliopsoas muscle; the iliacus muscle fibers were retracted anteriorly until the deeply seated posteromedially psoas tendon was isolated and transected

Group Type EXPERIMENTAL

Proximal level

Intervention Type PROCEDURE

For the proximal level of psoas tenotomy at the pelvic brim, the hip was slightly flexed to relax the iliopsoas muscle; the iliacus muscle fibers were retracted anteriorly until the deeply seated posteromedially psoas tendon was isolated and transected

Group 2

. For the distal level of iliopsoas tenotomy just above the lesser trochanter, the thigh was put in the position of FABER (flexion, abduction, and external rotation). A curved right-angle hemostatic clamp was used to retract and bring the iliopsoas tendon into the field. Then, the tendinous fibers were transected.

Group Type ACTIVE_COMPARATOR

Distal level

Intervention Type PROCEDURE

For the distal level of iliopsoas tenotomy just above the lesser trochanter, the thigh was put in the position of FABER (flexion, abduction, and external rotation). A curved right-angle hemostatic clamp was used to retract and bring the iliopsoas tendon into the field. Then, the tendinous fibers were transected.

Interventions

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Proximal level

For the proximal level of psoas tenotomy at the pelvic brim, the hip was slightly flexed to relax the iliopsoas muscle; the iliacus muscle fibers were retracted anteriorly until the deeply seated posteromedially psoas tendon was isolated and transected

Intervention Type PROCEDURE

Distal level

For the distal level of iliopsoas tenotomy just above the lesser trochanter, the thigh was put in the position of FABER (flexion, abduction, and external rotation). A curved right-angle hemostatic clamp was used to retract and bring the iliopsoas tendon into the field. Then, the tendinous fibers were transected.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children with DDH.
* Required open reduction of their hip problem.

Exclusion Criteria

* Patients who underwent hip surgery without the need for sectioning the iliopsoas tendon.
* Children with mental retardation who were not cooperative in the assessment of the hip flexion strength.
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Duhok

OTHER

Sponsor Role lead

Responsible Party

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Jagar Omar Doski

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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College of Medicine/University of Duhok

Dihok, , Iraq

Site Status

Countries

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Iraq

Other Identifiers

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Jagar Doski

Identifier Type: -

Identifier Source: org_study_id