- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06176612
In Patients With Hip Dysplasia, Mid-Term Lower Extremities and Spine After Hip Arthroplasty Natural Course
March 26, 2025 updated by: Bezmialem Vakif University
In Patients With Crowe Type III and Crowe Type IV Hip Dysplasia, Mid-Term Lower Extremities and Spine After Total Hip Arthroplasty Natural Course
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Developmental hip dysplasia (DDH) describes the spectrum of anatomical changes in the acetabulum and proximal femur; these can cause limping, lower back pain, lumbar lordosis, and leg length variation.
DDH is the main cause of degenerative arthritis of the hip and valgus deformity of the knee.
The best treatment option for DDH is total hip arthroplasty (THA).
During THA, the distorted anatomy of the acetabulum and proximal femur poses great difficulties.
Additionally, the soft tissue can be released and the femur can be shortened while correcting the placement of the acetabulum to prevent neurological damage (sciatic nerve paralysis).
Postoperative evaluations focused on assessing joint function and alleviating preoperative clinical symptoms.
Some studies have examined changes in lower extremity and knee alignment after THA in patients with DDH.
In patients with DDH, THA may cause genu valgus deformity due to increased lower extremity length and Q angle immediately after the operation.
THA extends the lower extremity, affecting the patellofemoral joint and anterior knee pain.
However, the long-term effects of THA on the alignment of the lower extremity are unclear, especially in patients with Crowe type III and IV DDH, which involves femoral shortening osteotomy.
There are few studies examining changes in the knee and lower extremities as a result of THA in patients with DDH.
The aim of this study is to evaluate the mid- and long-term alignment of the spine and lower extremity after THA with or without femoral shortening osteotomy in patients with unilateral DDH (Crowe type III-IV).
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fatih
-
Istanbul, Fatih, Turkey, 34093
- Bezmialem Vakıf University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with unilateral Crowe type 3 hip dysplasia
- Patients with unilateral Crowe type 4 hip dysplasia
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent total hip replacement
|
Patients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent hip replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mechanical axis deviation (MAD)
Time Frame: From enrollment to the end of treatment at 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tibiofemoral angle (TFA)
Time Frame: From enrollment to the end of treatment at 2 years
|
the angle formed by the line from the center of the femoral canal to the center of the knee joint and the line from the center of the knee joint to the center of the ankle joint.
|
From enrollment to the end of treatment at 2 years
|
|
The femoral offset (FO)
Time Frame: From enrollment to the end of treatment at 2 years
|
the vertical distances from the center of the femoral head to the center of the femoral canal
|
From enrollment to the end of treatment at 2 years
|
|
The hip-knee-ankle angle (HKA)
Time Frame: From enrollment to the end of treatment at 2 years
|
the angle formed by the mechanical axis of the femur and the mechanical axis of the tibia
|
From enrollment to the end of treatment at 2 years
|
|
The lateral distal femoral angle (LDFA)
Time Frame: From enrollment to the end of treatment at 2 years
|
the angle formed by the anatomic axis of the femur and the distal femoral joint orientation line
|
From enrollment to the end of treatment at 2 years
|
|
The medial proximal tibial angle (MPTA)
Time Frame: From enrollment to the end of treatment at 2 years
|
the angle formed by the anatomic axis of the tibia and the proximal tibial joint orientation line
|
From enrollment to the end of treatment at 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2021
Primary Completion (Actual)
November 15, 2023
Study Completion (Actual)
October 1, 2024
Study Registration Dates
First Submitted
December 10, 2023
First Submitted That Met QC Criteria
December 10, 2023
First Posted (Actual)
December 19, 2023
Study Record Updates
Last Update Posted (Actual)
April 1, 2025
Last Update Submitted That Met QC Criteria
March 26, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A10207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
I do not think it is right that the data of the patients in the study can be seen by everyone.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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