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Completed

NCT Number: NCT06176612

In Patients With Hip Dysplasia, Mid-Term Lower Extremities and Spine After 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.

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Key information

Conditions

Total Hip Arthroplasty Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip Hip Dislocation Joint Diseases Joint Dislocations Musculoskeletal Abnormalities Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Hip Arthroplasty

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

In Patients With Crowe Type III and Crowe Type IV Hip Dysplasia, Mid-Term Lower Extremities and Spine After Total Hip Arthroplasty Natural Course

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 19, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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