Level of Iliopsoas Tenotomy in DDH Surgery

NCT06742749 | Completed DMC

• 1 other identifier: Jagar Doski
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Dysplasia of the Hip (DDH)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• complications

  12 months

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

ACTIVE COMPARATOR

. 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

Interventions

Proximal level 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 1

Distal level 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.

Group 2

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Duhok: lead

Study Sites (1)

College of Medicine/University of Duhok

Duhok, 42001, Iraq

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 19, 2024
• Study Start: January 2, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 27, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from 1 year till 5 years
• Access Criteria: contact author

Locations

IR (1)