NCT06176612

Brief Summary

Patients with developmental hip dysplasia often present to the outpatient clinic in adulthood with hip pain due to progressive hip osteoarthritis. However, they may have complaints such as limping, lumbar lordosis, lower back pain, and leg length difference. Today, the best treatment option for these patients is hip arthroplasty. Hip arthroplasty causes a high rate of functional improvement and pain relief. According to the hip arthroplasty technique applied, improvement in lameness, leg length difference and spinal curvatures is expected. The aim of our study is to show the change in postoperative spine and lower extremity curvatures after hip arthroplasty in patients with advanced developmental hip dislocation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 15, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

2.6 years

First QC Date

December 10, 2023

Last Update Submit

March 26, 2025

Conditions

Keywords

hipTotal hip arthroplastydevelopmental hip dysplasia

Outcome Measures

Primary Outcomes (1)

  • Mechanical axis deviation (MAD)

    the lower limb was defined as the distance from the center of the knee to the mechanical axis of the lower limb

    From enrollment to the end of treatment at 2 years

Secondary Outcomes (5)

  • tibiofemoral angle (TFA)

    From enrollment to the end of treatment at 2 years

  • The femoral offset (FO)

    From enrollment to the end of treatment at 2 years

  • The hip-knee-ankle angle (HKA)

    From enrollment to the end of treatment at 2 years

  • The lateral distal femoral angle (LDFA)

    From enrollment to the end of treatment at 2 years

  • The medial proximal tibial angle (MPTA)

    From enrollment to the end of treatment at 2 years

Study Arms (1)

Patients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent total hip replacement

EXPERIMENTAL
Procedure: total hip arthroplasty

Interventions

Patients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent hip replacement

Patients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent total hip replacement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with unilateral Crowe type 3 hip dysplasia
  • Patients with unilateral Crowe type 4 hip dysplasia

You may not qualify if:

  • Patients with unilateral Crowe type 1 hip dysplasia
  • Patients with unilateral Crowe type 2 hip dysplasia
  • History of previous surgery on the hip for which surgery is planned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (3)

  • Can A, Erdogan F, Yontar NS, Ovul Erdogan A, Erdem MN, Sarikaya IA. Spinopelvic alignment does not change after bilateral total hip arthroplasty in patients with bilateral Crowe type-IV developmental dysplasia of the hip. Acta Orthop Traumatol Turc. 2020 Nov;54(6):583-586. doi: 10.5152/j.aott.2020.19043.

  • Zhao HY, Kang PD, Shi XJ, Zhou ZK, Yang J, Shen B, Pei FX. Effects of Total Hip Arthroplasty on Axial Alignment of the Lower Limb in Patients with Unilateral Developmental Hip Dysplasia (Crowe type IV). J Arthroplasty. 2019 Oct;34(10):2406-2414. doi: 10.1016/j.arth.2019.04.028. Epub 2019 Apr 20.

  • Kocabiyik A, Misir A, Kizkapan TB, Yildiz KI, Kaygusuz MA, Alpay Y, Ezici A. Changes in Hip, Knee, and Ankle Coronal Alignments After Total Hip Arthroplasty With Transverse Femoral Shortening Osteotomy for Unilateral Crowe Type IV Developmental Dysplasia of the Hip. J Arthroplasty. 2017 Nov;32(11):3449-3456. doi: 10.1016/j.arth.2017.05.044. Epub 2017 Jun 1.

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Hip DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2023

First Posted

December 19, 2023

Study Start

April 15, 2021

Primary Completion

November 15, 2023

Study Completion

October 1, 2024

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

I do not think it is right that the data of the patients in the study can be seen by everyone.

Locations