Level of Iliopsoas Tenotomy in DDH Surgery

Not Applicable

Completed

• Conditions: Developmental Dysplasia of the Hip (DDH)

• Registration Number: NCT06742749
• Lead Sponsor: University of Duhok

Brief Summary

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

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 Timeline

• Study Start: 2021-01-02
• Primary Completion: 2022-12-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-14
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-19
• Study Completion: 2024-12-27
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
hip flexion strength	at 6th, 12th, and 24th months post-operatively	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.

Secondary Outcome Measures

Name	Time	Method
complications	12 months	: 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

Trial Locations

Locations (1)

College of Medicine/University of Duhok; 🇮🇶 Duhok, Iraq