Level of Iliopsoas Tenotomy in DDH Surgery

Proximal Versus Distal Tenotomy of the Iliopsoas Tendon in the Surgical Treatment of Developmental Dysplasia of the Hip: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Developmental Dysplasia of the Hip (DDH)
• Intervention / Treatment: Procedure: Proximal level; Procedure: Distal level

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Duhok, Iraq, 42001
    • College of Medicine/University of Duhok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hip flexion strength	The strength was assessed clinically using the Medical Research Council Manual Muscle Testing scale. It evaluated muscle strength by testing the key muscle against gravity and the examiner's resistance. The scale graded muscle strength into six grades (from 0 to 5): Grade 0, no muscle activation and no movement; Grade 1, trace muscle activation, a flicker of movement, but without achieving full range of motion; Grade 2, muscle activation and achieving full range of motion with eliminated gravity; Grade 3, muscle activation and achieving full range of motion against gravity; Grade 4, muscle activation and achieving full range of motion against some resistance; Grade 5, muscle activation and achieving full range of motion against strong resistance.	at 6th, 12th, and 24th months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	: femoral nerve injury detected postoperatively by the inability to extend the knee actively from paralysis of the quadriceps muscle; medial circumflex femoral vessels injury detected intraoperatively by the active bleeding that may occur during iliopsoas tenotomy at the distal level (just above the lesser trochanter); avascular necrosis (AVN) of the femoral epiphysis detected postoperatively by the radiographic film when the femoral head failed to ossify or to grow within one year after being reduced, widening of the femoral neck within one year of reduction, changes in the bone density of the femoral head, and residual deformity that suggested growth disturbance	12 months

Collaborators and Investigators

• Sponsor: University of Duhok

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 27, 2024

Study Registration Dates

• First Submitted: December 14, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Hip; surgical treatment; Randomized Clinical Trial; Developmental Dysplasia of the hip; Iliopsoas Tenotomy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: Jagar Doski

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: from 1 year till 5 years
• IPD Sharing Access Criteria: contact author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No